<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03297606</url>
  </required_header>
  <id_info>
    <org_study_id>PM1</org_study_id>
    <secondary_id>ESR-17-12831</secondary_id>
    <secondary_id>CA209-9DL</secondary_id>
    <secondary_id>ML39800</secondary_id>
    <secondary_id>WI233446</secondary_id>
    <nct_id>NCT03297606</nct_id>
  </id_info>
  <brief_title>Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)</brief_title>
  <acronym>CAPTUR</acronym>
  <official_title>Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canadian Cancer Trials Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seagen Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Canadian Cancer Trials Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer drugs which target the effects of abnormal gene changes are called 'targeted&#xD;
      therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are&#xD;
      currently available. The purpose of this study is to find out what are the effects on a&#xD;
      patient and their cancer when they are given a targeted therapy drug that is specific to an&#xD;
      abnormal gene change in their cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent advances in laboratory technology have enabled the identification of changes in the&#xD;
      genetic makeup of tumors that might be responsible for their malignant behavior such as&#xD;
      uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be&#xD;
      cancer medicines that can specifically act on the tumour's genetic abnormality. Several&#xD;
      cancer centers and programs have initiated this type of molecular profiling across Canada,&#xD;
      with the goal to identify 'druggable' changes in tumors to find matching therapy for&#xD;
      patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian&#xD;
      Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of&#xD;
      commercially available targeted agents in patients who have undergone tumor profiling and&#xD;
      have 'druggable' changes identified in their cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 23, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2026</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate defined as the number of patients with complete response or partial response</measure>
    <time_frame>4 years</time_frame>
    <description>over the total number of patients in a given cohort.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and severity of adverse events grade &gt;3, or of lesser grade resulting in discontinuation, delay or reduction in dose of study drug</measure>
    <time_frame>4 years</time_frame>
    <description>measured by CTCAE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival by disease-appropriate objective criteria</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <number_of_arms>14</number_of_arms>
  <enrollment type="Anticipated">720</enrollment>
  <condition>Lymphoma, Non-Hodgkin</condition>
  <condition>Multiple Myeloma</condition>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Group 1 - Arm CLOSED, no patients recruited</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VEGFR1, VEGFR2, VEGFR3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Arm CLOSED, no patients recruited</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BCR-ABL, SRC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 - Arm CLOSED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALK, ROS1, MET</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 - Arm CLOSED, no patients recruited</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KIT, PDGFRA, PDGFRB, ABL1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6 - Arm CLOSED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high mutation burden, POLE, POLD1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BRCA1, BRCA2, mutations in HRD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CDKN2A, CDK4, CCND1, SMARCA4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 9 Arm CLOSED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STK11, TSC1, TSC2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 11 - Arm CLOSED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ERBB2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BRAFV600</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 13</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTCH1, SMO</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 14</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ERBB2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>300mg taken twice daily</description>
    <arm_group_label>Group 7</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dasatinib</intervention_name>
    <description>100mg administered orally once daily</description>
    <arm_group_label>Group 4 - Arm CLOSED, no patients recruited</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab plus Ipilimumab</intervention_name>
    <description>Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase.&#xD;
Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks.</description>
    <arm_group_label>Group 6 - Arm CLOSED</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Axitinib</intervention_name>
    <description>5mg orally twice daily</description>
    <arm_group_label>Group 1 - Arm CLOSED, no patients recruited</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bosutinib</intervention_name>
    <description>500mg orally once daily</description>
    <arm_group_label>Group 2 - Arm CLOSED, no patients recruited</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crizotinib</intervention_name>
    <description>250mg orally twice daily</description>
    <arm_group_label>Group 3 - Arm CLOSED</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palbociclib</intervention_name>
    <description>125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days</description>
    <arm_group_label>Group 8</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sunitinib</intervention_name>
    <description>50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off</description>
    <arm_group_label>Group 9 Arm CLOSED</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temsirolimus</intervention_name>
    <description>25mg infused over a 30-60 minute period once a week</description>
    <arm_group_label>Group 10</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erlotinib</intervention_name>
    <description>150mg orally, once daily</description>
    <arm_group_label>Group 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab plus Pertuzumab</intervention_name>
    <description>Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion.&#xD;
Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.</description>
    <arm_group_label>Group 11 - Arm CLOSED</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vemurafenib plus Cobimetinib</intervention_name>
    <description>Vemurafenib = 960 mg orally every 12 hours.&#xD;
Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest</description>
    <arm_group_label>Group 12</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vismodegib</intervention_name>
    <description>150mg taken orally, once daily</description>
    <arm_group_label>Group 13</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tucatinib</intervention_name>
    <description>300mg taken orally, twice daily</description>
    <arm_group_label>Group 14</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: (screening step - non-drug specific)&#xD;
&#xD;
          -  Adult (≥ 18 yrs) patient with a histologically-proven incurable metastatic solid&#xD;
             tumour (excluding primary brain tumours), multiple myeloma or B cell non-Hodgkin&#xD;
             lymphoma (excluding CLL, SLL and HCL), for whom there is no standard treatment known&#xD;
             to prolong life, or who has refused such treatment.&#xD;
&#xD;
          -  ECOG performance status 0-2.&#xD;
&#xD;
          -  Patients must have normal organ function as follows:&#xD;
&#xD;
               -  Absolute neutrophil count: ≥ 1.5 x 10^9/L for solid tumours; ≥ 1.0 x 10^9/L for&#xD;
                  neurologic malignancies&#xD;
&#xD;
               -  Platelets ≥ 75 x 10^9/L (or ≥ 50 x 10^9/L if bone marrow involvement by myeloma&#xD;
                  or lymphoma).&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x UNL.&#xD;
&#xD;
               -  AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal value unless&#xD;
                  liver metastases are present in which case they must be &lt; 5 x ULN;&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x UNL or calculated or measured creatinine clearance ≥&#xD;
                  50mg/min/1.73µ^2&#xD;
&#xD;
          -  Patients must have measurable disease&#xD;
&#xD;
          -  Results must be available from tumour genomic or protein expression testing (if used&#xD;
             to identify genetic variants), from one of the initiatives / groups listed in protocol&#xD;
             Appendix VII. The test may have been performed on the primary tumour or a metastatic&#xD;
             deposit (including bone marrow), or blood, in a diagnostic or research laboratory and&#xD;
             must reveal a potentially actionable variant.&#xD;
&#xD;
          -  Patient consent (Main Study Consent for the screening step) must be appropriately&#xD;
             obtained in accordance with applicable local and regulatory requirements. Each patient&#xD;
             must sign a consent form prior to the screening step to document their willingness to&#xD;
             participate&#xD;
&#xD;
          -  Patients must be accessible for treatment and follow-up. Patients registered on this&#xD;
             trial must be treated and followed at the participating centre or a CCTG IND site.&#xD;
             This implies there must be reasonable geographical limits (for example: 1 ½ hour's&#xD;
             driving distance) placed on patients being considered for this trial.&#xD;
&#xD;
          -  Women/men of childbearing potential must have agreed to use a highly effective&#xD;
             contraceptive method.&#xD;
&#xD;
        Exclusion Criteria: (screening step - non-drug specific)&#xD;
&#xD;
          -  Patients with prior or concurrent malignancy whose natural history or treatment has&#xD;
             the potential to interfere with the safety or efficacy assessment of the&#xD;
             investigational regimen.&#xD;
&#xD;
          -  Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy or&#xD;
             asymptomatic, corrected biochemical toxicities (e.g. hypothyroidism corrected by&#xD;
             thyroid replacement), related to prior anti-tumour treatment. Patients with ongoing&#xD;
             peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.&#xD;
&#xD;
          -  Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic,&#xD;
             radiation, or hormonal other than for replacement) except for medications that are&#xD;
             prescribed for supportive care but may potentially have an anti-cancer effect (e.g.&#xD;
             megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate&#xD;
             cancer. These medications must have been started ≥ one month prior to enrollment on&#xD;
             this study. Patients may be on warfarin, low molecular weight heparin or direct factor&#xD;
             Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility&#xD;
             criteria.&#xD;
&#xD;
          -  Patients with known active progressive brain metastases. Patients with previously&#xD;
             treated brain metastases are eligible, provided that the patient has not experienced a&#xD;
             seizure or had a clinically significant change in neurological status within one month&#xD;
             prior to screening. All patients with previously treated brain metastases must be&#xD;
             stable (clinically and radiologically) for at least one month after completion of&#xD;
             treatment and either off steroid treatment or only taking physiological doses of&#xD;
             steroids prior to the screening step.&#xD;
&#xD;
          -  Patients with clinically significant pre-existing cardiac conditions, including&#xD;
             uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or&#xD;
             symptomatic congestive heart failure.&#xD;
&#xD;
          -  Patients with known left ventricular ejection fraction (LVEF) &lt; 40%.&#xD;
&#xD;
          -  Patients with stroke (including TIA) or acute myocardial infarction within three&#xD;
             months prior to the screening step.&#xD;
&#xD;
          -  Patients with acute gastrointestinal bleeding within one month prior to the screening&#xD;
             step.&#xD;
&#xD;
          -  Patients with any other clinically significant medical condition which, in the opinion&#xD;
             of the treating physician, makes it undesirable for the patient to participate in the&#xD;
             study or which could jeopardize compliance with study requirements including, but not&#xD;
             limited to: ongoing or active infection, significant uncontrolled hypertension, or&#xD;
             severe psychiatric illness/social situations.&#xD;
&#xD;
          -  Lactating and nursing women&#xD;
&#xD;
          -  Patients who do not meet drug-specific eligibility requirements for the drug selected&#xD;
             by the treating physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lillian Siu</last_name>
    <role>Study Chair</role>
    <affiliation>Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel J Renouf</last_name>
    <role>Study Chair</role>
    <affiliation>BCCA - Vancouver Cancer Centre, Vancouver BC, Canada</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Janet Dancey</last_name>
    <phone>613-533-6430</phone>
    <email>jdancey@ctg.queensu.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quincy Chu</last_name>
      <phone>780 432-8248</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>BCCA - Cancer Centre for the Southern Interior</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5L3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Kristina Taylor</last_name>
      <phone>250 712-3996</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>BCCA - Vancouver Cancer Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel John Renouf</last_name>
      <phone>604 877-6000</phone>
      <phone_ext>672357</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kingston Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francisco Vera-Badillo</last_name>
      <phone>613 533-6430</phone>
      <phone_ext>79893</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>London Regional Cancer Program</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Welch</last_name>
      <phone>519 685-8640</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Hilton</last_name>
      <phone>613 737-7700</phone>
      <phone_ext>75086</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lillian Siu</last_name>
      <phone>416 946-2911</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petr Kavan</last_name>
      <phone>514 398-1444</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Allan Blair Cancer Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4T 7T1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Hagel</last_name>
      <phone>306 766-2691</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saskatoon Cancer Centre</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sunil K. Yadav</last_name>
      <phone>306 655-2710</phone>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
    <mesh_term>Pertuzumab</mesh_term>
    <mesh_term>Sunitinib</mesh_term>
    <mesh_term>Dasatinib</mesh_term>
    <mesh_term>Olaparib</mesh_term>
    <mesh_term>Palbociclib</mesh_term>
    <mesh_term>Temsirolimus</mesh_term>
    <mesh_term>Axitinib</mesh_term>
    <mesh_term>Vemurafenib</mesh_term>
    <mesh_term>Crizotinib</mesh_term>
    <mesh_term>Tucatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297606
org study id: PM1
secondary id: ESR-17-12831
secondary id: CA209-9DL
secondary id: ML39800
secondary id: WI233446
nct id: NCT03297606
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cancer drugs which target the effects of abnormal gene changes are called 'targeted
      therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are
      currently available. The purpose of this study is to find out what are the effects on a
      patient and their cancer when they are given a targeted therapy drug that is specific to an
      abnormal gene change in their cancer.
Recent advances in laboratory technology have enabled the identification of changes in the
      genetic makeup of tumors that might be responsible for their malignant behavior such as
      uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be
      cancer medicines that can specifically act on the tumour's genetic abnormality. Several
      cancer centers and programs have initiated this type of molecular profiling across Canada,
      with the goal to identify 'druggable' changes in tumors to find matching therapy for
      patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian
      Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of
      commercially available targeted agents in patients who have undergone tumor profiling and
      have 'druggable' changes identified in their cancers.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate defined as the number of patients with complete response or partial response
time frame: 4 years
description: over the total number of patients in a given cohort.
measure: Number and severity of adverse events grade >3, or of lesser grade resulting in discontinuation, delay or reduction in dose of study drug
time frame: 4 years
description: measured by CTCAE
measure: Progression-free survival by disease-appropriate objective criteria
time frame: 4 years
arm group label: Group 1 - Arm CLOSED, no patients recruited
arm group type: Experimental
description: VEGFR1, VEGFR2, VEGFR3
arm group label: Group 2 - Arm CLOSED, no patients recruited
arm group type: Experimental
description: BCR-ABL, SRC
arm group label: Group 3 - Arm CLOSED
arm group type: Experimental
description: ALK, ROS1, MET
arm group label: Group 4 - Arm CLOSED, no patients recruited
arm group type: Experimental
description: KIT, PDGFRA, PDGFRB, ABL1
arm group label: Group 5
arm group type: Experimental
description: EGFR
arm group label: Group 6 - Arm CLOSED
arm group type: Experimental
description: high mutation burden, POLE, POLD1
arm group label: Group 7
arm group type: Experimental
description: BRCA1, BRCA2, mutations in HRD
arm group label: Group 8
arm group type: Experimental
description: CDKN2A, CDK4, CCND1, SMARCA4
arm group label: Group 9 Arm CLOSED
arm group type: Experimental
description: CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL
arm group label: Group 10
arm group type: Experimental
description: AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STK11, TSC1, TSC2
arm group label: Group 11 - Arm CLOSED
arm group type: Experimental
description: ERBB2
arm group label: Group 12
arm group type: Experimental
description: BRAFV600
arm group label: Group 13
arm group type: Experimental
description: PTCH1, SMO
arm group label: Group 14
arm group type: Experimental
description: ERBB2
intervention type: Drug
intervention name: Olaparib
description: 300mg taken twice daily
arm group label: Group 7
intervention type: Drug
intervention name: Dasatinib
description: 100mg administered orally once daily
arm group label: Group 4 - Arm CLOSED, no patients recruited
intervention type: Drug
intervention name: Nivolumab plus Ipilimumab
description: Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase.
Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks.
arm group label: Group 6 - Arm CLOSED
intervention type: Drug
intervention name: Axitinib
description: 5mg orally twice daily
arm group label: Group 1 - Arm CLOSED, no patients recruited
intervention type: Drug
intervention name: Bosutinib
description: 500mg orally once daily
arm group label: Group 2 - Arm CLOSED, no patients recruited
intervention type: Drug
intervention name: Crizotinib
description: 250mg orally twice daily
arm group label: Group 3 - Arm CLOSED
intervention type: Drug
intervention name: Palbociclib
description: 125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
arm group label: Group 8
intervention type: Drug
intervention name: Sunitinib
description: 50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off
arm group label: Group 9 Arm CLOSED
intervention type: Drug
intervention name: Temsirolimus
description: 25mg infused over a 30-60 minute period once a week
arm group label: Group 10
intervention type: Drug
intervention name: Erlotinib
description: 150mg orally, once daily
arm group label: Group 5
intervention type: Drug
intervention name: Trastuzumab plus Pertuzumab
description: Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion.
Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.
arm group label: Group 11 - Arm CLOSED
intervention type: Drug
intervention name: Vemurafenib plus Cobimetinib
description: Vemurafenib = 960 mg orally every 12 hours.
Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest
arm group label: Group 12
intervention type: Drug
intervention name: Vismodegib
description: 150mg taken orally, once daily
arm group label: Group 13
intervention type: Drug
intervention name: Tucatinib
description: 300mg taken orally, twice daily
arm group label: Group 14
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lillian Siu
role: Study Chair
affiliation: Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
last name: Daniel J Renouf
role: Study Chair
affiliation: BCCA - Vancouver Cancer Centre, Vancouver BC, Canada
last name: Janet Dancey
phone: 613-533-6430
email: jdancey@ctg.queensu.ca
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Nivolumab
mesh term: Trastuzumab
mesh term: Ipilimumab
mesh term: Pertuzumab
mesh term: Sunitinib
mesh term: Dasatinib
mesh term: Olaparib
mesh term: Palbociclib
mesh term: Temsirolimus
mesh term: Axitinib
mesh term: Vemurafenib
mesh term: Crizotinib
mesh term: Tucatinib
sharing ipd: No