Renal Cell CancerPhase 3NCT00061178
Efficacy and Safety Study of rhuMAb VEGF to Treat Metastatic Renal Cell Carcinoma
A Phase 3 study testing rhuMAb VEGF (Bevacizumab) in people with Renal Cell Cancer, run by Genentech, Inc..
Trial summary
The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer
- What is being tested?
- rhuMAb VEGF (Bevacizumab)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Histologically confirmed, metastatic renal cell cancer (RCC) of clear cell histology
- Clinical or radiographic evidence of disease progression (as assessed by the investigator and reviewed by the Sponsor) during or after completion of one, and only one, cytokine-based regimen for metastatic disease
- At least 21 days since any prior therapy for RCC
- Prior nephrectomy
- Use of an acceptable means of contraception (potentially fertile men and women)
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- ECOG performance status of 0 or 1
- Life expectancy >= 3 months
- Age 18 years or older
Who cannot join
- RCC of papillary or collecting-duct type
- More than one nonsurgical therapy for metastatic RCC (note that medroxyprogesterone acetate not used for physiologic replacement or birth control is considered a therapy for RCC for the purposes of this study)
- Prior treatment with thalidomide
- Radiotherapy within 14 days of Day 0
- Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study
- Pregnant or breast-feeding subjects
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- Any of the following screening clinical laboratory values: 24-hour urine collection with >= 1 g of protein; Serum creatinine > 2.0 mg/dL; Absolute neutrophil count (ANC) <500/mL; Platelet count <75,000/mL; INR >= 1.5; Total bilirubin > 2.0 mg/dL; AST or ALT > 5 x the upper limit of normal (ULN) for subjects with documented liver metastases or > 2.5 x the ULN for subjects without evidence of liver metastases; Hemoglobin < 9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level)
- Other invasive malignancies within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
- 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
- Inability to comply with study and/or follow-up procedures
About this study
Official title: Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy & Safety of rhuMAb VEGF in Previously Treated Metastatic Renal Cell Carcinoma
The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed.
- Conditions
- Renal Cell Cancer
- Being tested
- rhuMAb VEGF (Bevacizumab)
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhuMAb VEGF (Bevacizumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2003 (estimated)
Why it stopped: No patients were enrolled, study cancelled before start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061178
- Sponsor's protocol ID
- AVF2665g
- Status last verified
- Oct 2016
- First submitted
- 21 May 2003
- Last updated
- 19 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy & Safety of rhuMAb VEGF in Previously Treated Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00061178
- Acronym / sponsor ID
- AVF2665g
- Conditions
- Renal Cell Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled, study cancelled before start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 23 May 2003 (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.
The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Histologically confirmed, metastatic renal cell cancer (RCC) of clear cell histology
- Clinical or radiographic evidence of disease progression (as assessed by the investigator and reviewed by the Sponsor) during or after completion of one, and only one, cytokine-based regimen for metastatic disease
- At least 21 days since any prior therapy for RCC
- Prior nephrectomy
Key exclusion criteria (10 listed)
- RCC of papillary or collecting-duct type
- More than one nonsurgical therapy for metastatic RCC (note that medroxyprogesterone acetate not used for physiologic replacement or birth control is considered a therapy for RCC for the purposes of this study)
- Prior treatment with thalidomide
- Radiotherapy within 14 days of Day 0
- Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study
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 |
|---|---|---|
| rhuMAb VEGF (Bevacizumab) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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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 rhuMAb VEGF (Bevacizumab) in people with Renal Cell 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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 19 Oct 2016. 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 was withdrawn before enrolling participants, so there are no results.
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 19 Oct 2016.