<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/NCT03287271</url>
  </required_header>
  <id_info>
    <org_study_id>170517</org_study_id>
    <nct_id>NCT03287271</nct_id>
  </id_info>
  <brief_title>ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK</brief_title>
  <official_title>ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael McHale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Verastem, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nine Girls Ask</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the combination VS-6063, carboplatin, and&#xD;
      paclitaxel. in the treatment of patients with ovarian cancer. The study will evaluate whether&#xD;
      this regimen is safe. The study will also evaluate whether the regimen can reduce the amount&#xD;
      of cancerous cells in your body. If you agree, you will be treated with VS-6063 by mouth, as&#xD;
      well as carboplatin and paclitaxel infusions. Carboplatin and paclitaxel are approved by the&#xD;
      FDA for the treatment of ovarian cancer. VS-6063 is considered experimental because it is not&#xD;
      approved by the FDA for the treatment of cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)</measure>
    <time_frame>4 years</time_frame>
    <description>Measured Via Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>4 years</time_frame>
    <description>ORR by RECIST 1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)</measure>
    <time_frame>4 years</time_frame>
    <description>Measured Via Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire)</measure>
    <time_frame>4 years</time_frame>
    <description>Measured Via Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression free survival (PFS)</measure>
    <time_frame>4 years</time_frame>
    <description>PFS by RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival (OS)</measure>
    <time_frame>4 years</time_frame>
    <description>OS by RECIST 1.1.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Defactinib (VS-6063) +Carboplatin/Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VS-6063</intervention_name>
    <description>Phase 1:&#xD;
First 3 patient cohort: VS-6063 200 mg PO twice daily&#xD;
IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,&#xD;
Phase 2:&#xD;
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.</description>
    <arm_group_label>Defactinib (VS-6063) +Carboplatin/Paclitaxel</arm_group_label>
    <other_name>defactinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Phase 1:&#xD;
First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.&#xD;
IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.&#xD;
Phase 2:&#xD;
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.</description>
    <arm_group_label>Defactinib (VS-6063) +Carboplatin/Paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Phase 1:&#xD;
First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.&#xD;
IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.&#xD;
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.</description>
    <arm_group_label>Defactinib (VS-6063) +Carboplatin/Paclitaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal&#xD;
             carcinoma, diagnosed within 6 months of completing their most recent&#xD;
             platinum-containing chemotherapy.&#xD;
&#xD;
          -  Patients with the following histologic cell types are eligible: Serous adenocarcinoma,&#xD;
             endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma,&#xD;
             clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma,&#xD;
             malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)&#xD;
&#xD;
          -  Must have had one prior platinum-based chemotherapeutic regimen for management of&#xD;
             primary disease containing carboplatin, cisplatin, or another organoplatinum compound.&#xD;
             This initial treatment may have included intraperitoneal therapy, high-dose therapy,&#xD;
             consolidation, noncytotoxic agents or extended therapy administered after surgical or&#xD;
             non-surgical assessment.&#xD;
&#xD;
          -  Must have NOT received more than two total prior lines of cytotoxic chemotherapy for&#xD;
             management of recurrent or persistent disease, including retreatment with initial&#xD;
             chemotherapy regimens.&#xD;
&#xD;
          -  May have received one additional non-cytotoxic regimen for management of recurrent or&#xD;
             persistent disease according to the following definition: Non-cytotoxic (biologic or&#xD;
             cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies,&#xD;
             cytokines, and small molecule inhibitors of signal transduction.&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum pregnancy test prior to&#xD;
             study entry and be practicing an effective form of contraception.&#xD;
&#xD;
        Must have adequate:&#xD;
&#xD;
          -  Bone marrow function&#xD;
&#xD;
          -  Renal function&#xD;
&#xD;
          -  Hepatic function&#xD;
&#xD;
          -  Neurologic function&#xD;
&#xD;
          -  Recovered from effects of recent surgery, radiotherapy, or chemotherapy. All&#xD;
             persistent clinically significant toxicities from prior chemotherapy must be less than&#xD;
             or equal to Grade 1.&#xD;
&#xD;
          -  Free of active infection requiring antibiotics (with the exception of uncomplicated&#xD;
             UTI).&#xD;
&#xD;
          -  Any hormonal therapy directed at the malignant tumor must be discontinued at least one&#xD;
             week prior to registration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma.&#xD;
&#xD;
          -  Known second primary or prior malignancy diagnosed within 5 years of study start date&#xD;
             (other than previously treated non-melanoma skin cancer).&#xD;
&#xD;
          -  Current treatment with chemotherapy or radiation therapy. Any prior therapy directed&#xD;
             at the malignant tumor, including biologic and immunologic agents, must be&#xD;
             discontinued at least three weeks prior to registration.&#xD;
&#xD;
          -  History of treatment with known kinase inhibiting agents.&#xD;
&#xD;
          -  History of gastrointestinal fistula, hemorrhage, perforation or peptic ulcer disease.&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#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>Michael McHale</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael McHale, MD</last_name>
    <phone>(858) 822-6275</phone>
    <email>mtmchale@ucsd.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexandrea Cronin, MPH</last_name>
    <phone>(858) 822-3975</phone>
    <email>aocronin@health.ucsd.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92023</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandrea Cronin, MPH</last_name>
      <phone>858-822-3975</phone>
      <email>aocronin@health.ucsd.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Michael McHale</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>cancer</keyword>
  <keyword>ovary</keyword>
  <keyword>carboplatin</keyword>
  <keyword>paclitaxel</keyword>
  <keyword>VS-6063</keyword>
  <keyword>primary peritoneal carcinoma</keyword>
  <keyword>fallopian tube</keyword>
  <keyword>defactinib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</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/NCT03287271
org study id: 170517
nct id: NCT03287271
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to investigate the combination VS-6063, carboplatin, and
      paclitaxel. in the treatment of patients with ovarian cancer. The study will evaluate whether
      this regimen is safe. The study will also evaluate whether the regimen can reduce the amount
      of cancerous cells in your body. If you agree, you will be treated with VS-6063 by mouth, as
      well as carboplatin and paclitaxel infusions. Carboplatin and paclitaxel are approved by the
      FDA for the treatment of ovarian cancer. VS-6063 is considered experimental because it is not
      approved by the FDA for the treatment of cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
time frame: 4 years
description: Measured Via Adverse Events
measure: Objective response rate (ORR)
time frame: 4 years
description: ORR by RECIST 1.1.
measure: To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
time frame: 4 years
description: Measured Via Adverse Events
measure: To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire)
time frame: 4 years
description: Measured Via Questionnaire
measure: progression free survival (PFS)
time frame: 4 years
description: PFS by RECIST 1.1.
measure: overall survival (OS)
time frame: 4 years
description: OS by RECIST 1.1.
arm group label: Defactinib (VS-6063) +Carboplatin/Paclitaxel
arm group type: Experimental
intervention type: Drug
intervention name: VS-6063
description: Phase 1:
First 3 patient cohort: VS-6063 200 mg PO twice daily
IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
Phase 2:
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
arm group label: Defactinib (VS-6063) +Carboplatin/Paclitaxel
other name: defactinib
intervention type: Drug
intervention name: Paclitaxel
description: Phase 1:
First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
Phase 2:
Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
arm group label: Defactinib (VS-6063) +Carboplatin/Paclitaxel
intervention type: Drug
intervention name: Carboplatin
description: Phase 1:
First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
arm group label: Defactinib (VS-6063) +Carboplatin/Paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael McHale
role: Principal Investigator
affiliation: University of California, San Diego
last name: Michael McHale, MD
phone: (858) 822-6275
email: mtmchale@ucsd.edu
last name: Alexandrea Cronin, MPH
phone: (858) 822-3975
email: aocronin@health.ucsd.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, San Diego
investigator full name: Michael McHale
investigator title: Clinical Professor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Paclitaxel
mesh term: Carboplatin
sharing ipd: No