Know Cancer

or
forgot password

An Open-Label, Multicenter Extension Study of Recombinant Humanized Monoclonal Anti-VEGF Antibody (rhuMAb VEGF, Bevacizumab) in Subjects Treated With rhuMAb VEGF in a Previous Genentech-Sponsored Phase I or Phase II Cancer Study


Phase 2
N/A
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

An Open-Label, Multicenter Extension Study of Recombinant Humanized Monoclonal Anti-VEGF Antibody (rhuMAb VEGF, Bevacizumab) in Subjects Treated With rhuMAb VEGF in a Previous Genentech-Sponsored Phase I or Phase II Cancer Study


Inclusion Criteria:



- Previous participation in and completion of a Genentech-sponsored rhuMAb VEGF Phase I
or Phase II cancer study

- No evidence of progressive disease at completion of the parent study

- For women of childbearing potential, use of an effective means of contraception

- Signed informed consent

Exclusion Criteria:

- Any unresolved or irreversible rhuMAb VEGF-related ongoing serious adverse events
occurring during the parent study

- Any history of central nervous system disease (e.g., primary brain tumor or seizures
within 12 months of the first infusion on this study), and/or any evidence of brain
metastases

- Compromised renal or hepatic function, as defined in the parent protocol

- Anemia, neutropenia, or thrombocytopenia, as defined in the parent protocol

- Pregnancy (positive pregnancy test) or lactation

- 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

- Recent (within 3 weeks of the first infusion of this study) major surgical procedure,
biopsy of a parenchymal organ, or significant traumatic injury

- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [blood
pressure of >160/110 mmHg on medication], 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)

- Serious, nonhealing wound, ulcer, or bone fracture

- Current or recent (within 10 days of the first infusion on this study) use of oral or
parenteral anticoagulants or aspirin (except as required to maintain patency of
permanent indwelling intravenous [IV] catheters)

- 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

AVF0778g

NCT ID:

NCT00109057

Start Date:

February 1998

Completion Date:

February 2004

Related Keywords:

  • Cancer
  • Cancer
  • Advanced malignancies

Name

Location