<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/NCT01702714</url>
  </required_header>
  <id_info>
    <org_study_id>BP28577</org_study_id>
    <secondary_id>2012-003376-39</secondary_id>
    <nct_id>NCT01702714</nct_id>
  </id_info>
  <brief_title>A Study of RO5083945 in Combination With Cisplatin and Gemcitabine or Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer of Squamous Histology Who Have Not Received Prior Chemotherapy for The Metastatic Disease</brief_title>
  <official_title>A MULTICENTER, OPEN-LABEL PHASE IB STUDY OF RO5083945 IN COMBINATION WITH CISPLATIN AND GEMCITABINE OR CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH ADVANCED OR RECURRENT NON SMALL CELL LUNG CANCER OF SQUAMOUS HISTOLOGY WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR THE METASTATIC DISEASE.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an&#xD;
      expansion cohort will determine the recommended Phase II dose and schedule to investigate&#xD;
      safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine&#xD;
      or carboplatin and paclitaxel in patients with advanced or recurrent non-small cell lung&#xD;
      cancer of squamous histology who have not received prior chemotherapy for the metastatic&#xD;
      disease. Cohorts of patients will receive escalating doses of RO5083945 in combination with&#xD;
      up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time&#xD;
      on study treatment is until disease progression or unacceptable toxicity occurs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Project Team decision&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Anticipated">February 2016</primary_completion_date>
  <phase>Phase 1</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>Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel</measure>
    <time_frame>approximately 1.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel</measure>
    <time_frame>approximately 1.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 1.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel</measure>
    <time_frame>up to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin</measure>
    <time_frame>up to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine</measure>
    <time_frame>up to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin</measure>
    <time_frame>up to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel</measure>
    <time_frame>up to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease)</measure>
    <time_frame>approximately 1.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>approximately 1.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker assessments : Immune effector cells/EGFR markers</measure>
    <time_frame>up to 18 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-Squamous Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>RO5083945 + carboplatin + paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>RO5083945 + cisplatin +gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5083945</intervention_name>
    <description>multiple ascending doses</description>
    <arm_group_label>RO5083945 + carboplatin + paclitaxel</arm_group_label>
    <arm_group_label>RO5083945 + cisplatin +gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>carboplatin</intervention_name>
    <description>up to 6 cycles</description>
    <arm_group_label>RO5083945 + carboplatin + paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <description>up to 6 cycles</description>
    <arm_group_label>RO5083945 + cisplatin +gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemcitabine</intervention_name>
    <description>up to 6 cycles</description>
    <arm_group_label>RO5083945 + cisplatin +gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paclitaxel</intervention_name>
    <description>up to 6 cycles</description>
    <arm_group_label>RO5083945 + carboplatin + paclitaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Locally advanced (stage IIIB, excluding patients who are candidates for&#xD;
             chemo-radiotherapy or radical thoracic radiotherapy), metastatic (stage IV) or&#xD;
             recurrent squamous non-small cell lung cancer (NSCLC)&#xD;
&#xD;
          -  Histologically documented squamous NSCLC. Mixed tumors should be categorized according&#xD;
             to the predominant cell type&#xD;
&#xD;
          -  Histological tumor tissue sample from initial diagnosis or new tumor biopsy&#xD;
             representative of the disease&#xD;
&#xD;
          -  Patients who have received adjuvant chemotherapy are eligible if the last&#xD;
             administration of the prior adjuvant regimen occurred at least 3 months prior to&#xD;
             enrollment&#xD;
&#xD;
          -  At least one measurable disease lesion as per RECIST 1.1 criteria&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          -  Adequate hematological, liver and renal function&#xD;
&#xD;
          -  Females of childbearing potential must commit to using a reliable and appropriate&#xD;
             method of contraception until at least 3 months after the end of the last dose of&#xD;
             study treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior chemotherapy (excluding neoadjuvant/adjuvant chemotherapy/chemo-radiotherapy) or&#xD;
             treatment with another systemic anti-cancer agent (e.g. monoclonal antibody, tyrosine&#xD;
             kinase inhibitor)&#xD;
&#xD;
          -  Radiotherapy within the last 4 weeks prior to first dosing, except for limited field&#xD;
             palliative radiotherapy for bone pain relief&#xD;
&#xD;
          -  Treatment with any other investigational agent within 30 days prior to starting study&#xD;
             treatment or participation in another clinical trial (e.g. CTC blood collection)&#xD;
             within 7 days prior to starting study treatment&#xD;
&#xD;
          -  Historical or clinical evidence of central nervous system (CNS) metastases (except for&#xD;
             previously treated CNS metastases in patients that are asymptomatic, have had no&#xD;
             evidence of active CNS metastases for &gt;/= 3 months prior to first dose and have had no&#xD;
             requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days)&#xD;
&#xD;
          -  Recent history of poorly controlled hypertension (systolic &gt;180 mmHg or diastolic &gt;100&#xD;
             mmHg)&#xD;
&#xD;
          -  Severe uncontrolled illness, including poorly controlled diabetes mellitus and active&#xD;
             or uncontrolled infection&#xD;
&#xD;
          -  Hypersensitivity to the active substance or to any excipients or to any of the study&#xD;
             drugs including premedication (corticosteroids, anti-histamine, paracetamol)&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>November 3, 2016</last_update_submitted>
  <last_update_submitted_qc>November 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2016</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Neoplasm Metastasis</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>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01702714
org study id: BP28577
secondary id: 2012-003376-39
nct id: NCT01702714
lead sponsor: 
This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an
      expansion cohort will determine the recommended Phase II dose and schedule to investigate
      safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine
      or carboplatin and paclitaxel in patients with advanced or recurrent non-small cell lung
      cancer of squamous histology who have not received prior chemotherapy for the metastatic
      disease. Cohorts of patients will receive escalating doses of RO5083945 in combination with
      up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time
      on study treatment is until disease progression or unacceptable toxicity occurs.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
time frame: approximately 1.5 years
measure: Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
time frame: approximately 1.5 years
measure: Safety: Incidence of adverse events
time frame: approximately 1.5 years
measure: Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
time frame: up to 18 weeks
measure: Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin
time frame: up to 18 weeks
measure: Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine
time frame: up to 18 weeks
measure: Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin
time frame: up to 18 weeks
measure: Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel
time frame: up to 18 weeks
measure: Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease)
time frame: approximately 1.5 years
measure: Duration of response
time frame: approximately 1.5 years
measure: Biomarker assessments : Immune effector cells/EGFR markers
time frame: up to 18 weeks
arm group label: RO5083945 + carboplatin + paclitaxel
arm group type: Experimental
arm group label: RO5083945 + cisplatin +gemcitabine
arm group type: Experimental
intervention type: Drug
intervention name: RO5083945
description: multiple ascending doses
arm group label: RO5083945 + carboplatin + paclitaxel
arm group label: RO5083945 + cisplatin +gemcitabine
intervention type: Drug
intervention name: carboplatin
description: up to 6 cycles
arm group label: RO5083945 + carboplatin + paclitaxel
intervention type: Drug
intervention name: cisplatin
description: up to 6 cycles
arm group label: RO5083945 + cisplatin +gemcitabine
intervention type: Drug
intervention name: gemcitabine
description: up to 6 cycles
arm group label: RO5083945 + cisplatin +gemcitabine
intervention type: Drug
intervention name: paclitaxel
description: up to 6 cycles
arm group label: RO5083945 + carboplatin + paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Neoplasm Metastasis
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Gemcitabine