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A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
bevacizumab
cetuximab
FOLFIRI regimen
irinotecan
PRO95780
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring CRC, Colon cancer, Avastin, APM4187g

Eligibility Criteria

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

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 years
  • Histologically confirmed CRC with evidence of metastases and measurable tumor lesions
  • Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy
  • Life expectancy > 3 months
  • For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment
  • Willingness and capability to be accessible for study follow-up

Exclusion Criteria:

  • Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens
  • Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
  • Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field
  • Recent chemotherapy, hormonal therapy, or immunotherapy
  • Evidence of clinically detectable ascites
  • Other invasive malignancies within 5 years
  • History or evidence of active central nervous system (CNS) disease
  • Current or recent participation in another experimental drug study
  • Clinically significant cardiovascular disease
  • Active infection requiring parenteral antibiotics
  • Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, or anticipation of need for major surgical procedure during the course of the study
  • Known or suspected to be positive for the human immunodeficiency virus (HIV)
  • Known to be positive for hepatitis C or hepatitis B surface antigen
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment
  • Pregnancy (positive pregnancy test) or breast feeding
  • Serious, non-healing wound, ulcer, or bone fracture
  • Known sensitivity to any of the products administered during the study
  • Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence and nature of dose-limiting toxicities

    Secondary Outcome Measures

    Incidence, nature, and severity of adverse events
    Change in vital signs
    Incidence and severity of infusion reactions

    Full Information

    First Posted
    July 3, 2007
    Last Updated
    May 18, 2017
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00497497
    Brief Title
    A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)
    Official Title
    A Phase Ib, Dose-Escalation Study of the Safety and Pharmacokinetics of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (Actual)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 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 Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    CRC, Colon cancer, Avastin, APM4187g

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    bevacizumab
    Intervention Description
    (Only for patients not previously treated with bevacizumab) Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    cetuximab
    Intervention Description
    Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    FOLFIRI regimen
    Intervention Description
    Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    irinotecan
    Intervention Description
    Intravenous repeating dose
    Intervention Type
    Drug
    Intervention Name(s)
    PRO95780
    Intervention Description
    Intravenous repeating dose
    Primary Outcome Measure Information:
    Title
    Incidence and nature of dose-limiting toxicities
    Time Frame
    Through study completion or early study discontinuation
    Secondary Outcome Measure Information:
    Title
    Incidence, nature, and severity of adverse events
    Time Frame
    Through study completion or early study discontinuation
    Title
    Change in vital signs
    Time Frame
    Through study completion or early study discontinuation
    Title
    Incidence and severity of infusion reactions
    Time Frame
    Through study completion or early study discontinuation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Age ≥ 18 years Histologically confirmed CRC with evidence of metastases and measurable tumor lesions Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy Life expectancy > 3 months For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment Willingness and capability to be accessible for study follow-up Exclusion Criteria: Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field Recent chemotherapy, hormonal therapy, or immunotherapy Evidence of clinically detectable ascites Other invasive malignancies within 5 years History or evidence of active central nervous system (CNS) disease Current or recent participation in another experimental drug study Clinically significant cardiovascular disease Active infection requiring parenteral antibiotics Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, or anticipation of need for major surgical procedure during the course of the study Known or suspected to be positive for the human immunodeficiency virus (HIV) Known to be positive for hepatitis C or hepatitis B surface antigen History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment Pregnancy (positive pregnancy test) or breast feeding Serious, non-healing wound, ulcer, or bone fracture Known sensitivity to any of the products administered during the study Any disorder that compromises the ability of the patient to provide written informed consent and/or 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 Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)

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