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A Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study

Primary Purpose

Breast Cancer, Colorectal Cancer, Metastases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Avastin (bevacizumab)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic breast cancer, Metastatic colorectal cancer

Eligibility Criteria

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

Inclusion Criteria: Written informed consent Previous participation in and completion of one of the following Genentech-sponsored rhuMAb VEGF Phase II or Phase III cancer studies: AVF2107g, AVF2119g, or AVF2192g Use of an effective means of contraception in men and in women of childbearing potential For subjects who received placebo in the parent study, current antitumor therapy not exceeding third-line treatment for disease progression Exclusion Criteria: Compromised renal or hepatic function, as defined in the parent protocol EGOG status of 3 or greater Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored rhuMAb VEGF cancer study ANC of <1500/uL Platelet count of <75,000/uL International normalized ration (INR) >=1.5 (except those subjects who have been given approval to receive full-dose warfarin plus rhuMAb VEGF) Total bilirubin of >1.6 mg/dL for patients receiving irinotecan, for all others total bilirubin of >2.0 mg/dL AST or ALT >5 times upper limit of normal for subjects with documented liver metastases; >2.5 times the upper limit of normal for subjects without evidence of liver metastases Serum creatinine of >2.0 mg/dL Hemoglobin of <9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level) Inability to comply with study and/or follow-up procedures History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications Any unresolved or irreversible rhuMAb VEGF-related ongoing serious adverse event occurring during the parent study Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [blood pressure of >160/110 mmHg on medication], previous myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater) History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study Fine needle aspirations or core biopsies within 7 days prior to Day 0 Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases) Pregnancy (positive pregnancy test) or lactation Proteinuria at baseline or clinically significant impairment of renal function Serious, nonhealing wound, ulcer, or bone fracture Evidence of bleeding diathesis or coagulopathy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 17, 2004
    Last Updated
    March 25, 2014
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00096967
    Brief Title
    A Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study
    Official Title
    An Open-Label, Multicenter Extension Study of rhuMAb VEGF (Bevacizumab) in Subjects Treated in a Previous Genentech-Sponsored Cancer Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (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 multicenter, open-label extension study. Subjects who have received rhuMAb VEGF therapy in Study AVF2107g, AVF2119g, or AVF2192g and who completed the parent study are eligible for inclusion in this trial. Subjects who have received placebo in Study AVF2107g or AVF2192g are also eligible.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Colorectal Cancer, Metastases
    Keywords
    Metastatic breast cancer, Metastatic colorectal cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    None (Open Label)
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Avastin (bevacizumab)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written informed consent Previous participation in and completion of one of the following Genentech-sponsored rhuMAb VEGF Phase II or Phase III cancer studies: AVF2107g, AVF2119g, or AVF2192g Use of an effective means of contraception in men and in women of childbearing potential For subjects who received placebo in the parent study, current antitumor therapy not exceeding third-line treatment for disease progression Exclusion Criteria: Compromised renal or hepatic function, as defined in the parent protocol EGOG status of 3 or greater Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored rhuMAb VEGF cancer study ANC of <1500/uL Platelet count of <75,000/uL International normalized ration (INR) >=1.5 (except those subjects who have been given approval to receive full-dose warfarin plus rhuMAb VEGF) Total bilirubin of >1.6 mg/dL for patients receiving irinotecan, for all others total bilirubin of >2.0 mg/dL AST or ALT >5 times upper limit of normal for subjects with documented liver metastases; >2.5 times the upper limit of normal for subjects without evidence of liver metastases Serum creatinine of >2.0 mg/dL Hemoglobin of <9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level) Inability to comply with study and/or follow-up procedures History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications Any unresolved or irreversible rhuMAb VEGF-related ongoing serious adverse event occurring during the parent study Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [blood pressure of >160/110 mmHg on medication], previous myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater) History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study Fine needle aspirations or core biopsies within 7 days prior to Day 0 Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases) Pregnancy (positive pregnancy test) or lactation Proteinuria at baseline or clinically significant impairment of renal function Serious, nonhealing wound, ulcer, or bone fracture Evidence of bleeding diathesis or coagulopathy

    12. IPD Sharing Statement

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    A Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study

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