CancerPhase 2NCT00109057
An Extension Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study
A Phase 2 study testing Avastin (bevacizumab) in people with Cancer, run by Genentech, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Avastin (bevacizumab)
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to Feb 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
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.
- Conditions
- Cancer
- Being tested
- Avastin (bevacizumab)
- Keywords
- Cancer, Advanced malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (bevacizumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2005 (estimated)
- Study startFeb 1998
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109057
- Sponsor's protocol ID
- AVF0778g
- Status last verified
- Jun 2013
- First submitted
- 22 Apr 2005
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00109057
- Acronym / sponsor ID
- AVF0778g
- Conditions
- Cancer
- Keywords
- Cancer, Advanced malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 1998
- Study completion
- Feb 2004 (actual)
- First posted
- 25 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avastin (bevacizumab) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin (bevacizumab) in people with Cancer, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.