Breast CancerPhase 3NCT00096967
A Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study
A Phase 3 study testing Avastin (bevacizumab) in people with Breast Cancer and Colorectal Cancer, run by Genentech, Inc..
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Metastases
- What is being tested?
- Avastin (bevacizumab)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Jul 2004
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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)
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- 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
About this study
Official title: An Open-Label, Multicenter Extension Study of rhuMAb VEGF (Bevacizumab) in Subjects Treated in a Previous Genentech-Sponsored Cancer Study
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.
- Conditions
- Breast Cancer, Colorectal Cancer, Metastases
- Being tested
- Avastin (bevacizumab)
- Keywords
- Metastatic breast cancer, Metastatic colorectal cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis
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 posted18 Nov 2004 (estimated)
- Study startOct 2002
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096967
- Sponsor's protocol ID
- AVF2540g
- Status last verified
- Mar 2014
- First submitted
- 17 Nov 2004
- Last updated
- 26 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Extension Study of rhuMAb VEGF (Bevacizumab) in Subjects Treated in a Previous Genentech-Sponsored Cancer Study
- ClinicalTrials.gov ID
- NCT00096967
- Acronym / sponsor ID
- AVF2540g
- Conditions
- Breast Cancer, Colorectal Cancer, Metastases
- Keywords
- Metastatic breast cancer, Metastatic colorectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Jul 2004 (actual)
- First posted
- 18 Nov 2004 (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 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.
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)
- 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
Key exclusion criteria (22 listed)
- 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
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 26 Mar 2014.
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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 3 study testing Avastin (bevacizumab) in people with Breast Cancer and Colorectal 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 22 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 26 Mar 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Mar 2014.