search
Back to results

A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bevacizumab
carboplatin
paclitaxel
placebo
PRO95780
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC, Cancer, Avastin, APM4074g

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to understand and willingness to sign a written informed consent
  • Histologically or cytologically confirmed NSCLC
  • Advanced NSCLC
  • Measurable disease
  • ECOG performance status of 0 or 1
  • Age ≥ 18 years
  • Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men

Exclusion Criteria:

  • Squamous cell histology
  • Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization
  • Untreated or unstable CNS metastases
  • Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization
  • Uncontrolled hypertension
  • History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization
  • Major surgical procedure within 28 days prior to randomization
  • Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization
  • Persistent history of gross hemoptysis relating to the patient's NSCLC
  • Known HIV infection
  • Known to be positive for hepatitis C or hepatitis B surface antigen
  • Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function
  • Use of anticoagulation therapy
  • Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization
  • Pregnancy (e.g., positive HCG test) or breast feeding
  • Known sensitivity to any of the products to be administered during the study
  • Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Adverse events
    Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration
    Progression-free survival, as determined by independent review facility

    Secondary Outcome Measures

    Objective response and duration of response, as determined by independent review facility
    Overall survival
    Progression-free survival, objective response, and duration of objective response, as determined by the investigator
    Pharmacokinetic parameters

    Full Information

    First Posted
    May 30, 2007
    Last Updated
    May 16, 2017
    Sponsor
    Genentech, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00480831
    Brief Title
    A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)
    Official Title
    A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2007 (Actual)
    Primary Completion Date
    August 2010 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer
    Keywords
    NSCLC, Cancer, Avastin, APM4074g

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    bevacizumab
    Intervention Description
    Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin
    Intervention Description
    Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    paclitaxel
    Intervention Description
    Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    PRO95780
    Intervention Description
    Intravenous repeating dose
    Primary Outcome Measure Information:
    Title
    Adverse events
    Time Frame
    Length of study
    Title
    Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration
    Time Frame
    Length of study
    Title
    Progression-free survival, as determined by independent review facility
    Time Frame
    Length of study
    Secondary Outcome Measure Information:
    Title
    Objective response and duration of response, as determined by independent review facility
    Time Frame
    Length of study
    Title
    Overall survival
    Time Frame
    24 months
    Title
    Progression-free survival, objective response, and duration of objective response, as determined by the investigator
    Time Frame
    Length of study
    Title
    Pharmacokinetic parameters
    Time Frame
    Length of study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to understand and willingness to sign a written informed consent Histologically or cytologically confirmed NSCLC Advanced NSCLC Measurable disease ECOG performance status of 0 or 1 Age ≥ 18 years Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men Exclusion Criteria: Squamous cell histology Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization Untreated or unstable CNS metastases Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization Uncontrolled hypertension History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization Major surgical procedure within 28 days prior to randomization Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization Persistent history of gross hemoptysis relating to the patient's NSCLC Known HIV infection Known to be positive for hepatitis C or hepatitis B surface antigen Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function Use of anticoagulation therapy Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization Pregnancy (e.g., positive HCG test) or breast feeding Known sensitivity to any of the products to be administered during the study Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gordon Bray, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)

    We'll reach out to this number within 24 hrs