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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00109057
First received: April 22, 2005
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF (Avastin) therapy in any Genentech-sponsored Phase I or Phase II cancer study and who did not show evidence of disease progression at completion of the parent study will be eligible for inclusion in this trial.


Condition Intervention Phase
Cancer
Drug: Avastin (bevacizumab)
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Enrollment: 56
Study Start Date: February 1998
Study Completion Date: February 2004
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00109057     History of Changes
Other Study ID Numbers: AVF0778g
Study First Received: April 22, 2005
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Cancer
Advanced malignancies

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014