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NCT00112840 · ClinicalTrials.gov registry record · Phase 1
CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00112840: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00112840 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00112840, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of CCI-779 and bevacizumab and to see how well they work in treating patients with metastatic or unresectable kidney cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving CCI-779 together with bevacizumab may kill more tumor cells.
Primary Outcome
For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria: * Grade 4 Absolute neutrophil count (ANC) for 5+ days. * Grade 4 anemia or thrombocytopenia of any duration. * Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal. * Any other non-hematologic grade 3 or higher as per NCI
Interventions
- DRUG Bevacizumab
- DRUG CCI-779
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-05 |
| Est. Completion | 2015-09-10 |
| Phase | Phase 1 |
What the finished NCT00112840 record still lists
NCT00112840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00112840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00112840 about?
NCT00112840 is a clinical study titled "CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer". This phase I/II trial is studying the side effects and best dose of CCI-779 and bevacizumab and to see how well they work in treating patients with metastatic or unresectable kidney cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either ...
What is the current status of trial NCT00112840?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2005-05. Estimated completion is 2015-09-10.
What interventions are being tested in trial NCT00112840?
The interventions under investigation include: Bevacizumab (DRUG), CCI-779 (DRUG).
Who is sponsoring clinical trial NCT00112840?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00112840's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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