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NCT00975806 · ClinicalTrials.gov registry record · Phase 1
Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00975806: Clinical Trial Phase 1 study, sponsored by Celgene.
NCT00975806 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00975806, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.
Primary Outcome
The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were: • Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in: * Grade (GR) 3 or 4 non-hematological toxicity lasting for ≥ 14 days * Febrile neutropenia * Gr 4 neutropenia lasting for ≥ 7 days * Gr 4 thrombocytopenia The occurrence of one of the above dru
Interventions
- DRUG Lenalidomide
- DRUG Sunitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-09-01 |
| Est. Completion | 2011-10-01 |
| Phase | Phase 1 |
Why NCT00975806 stopped before completion
NCT00975806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Lenalidomide is the first listed.
NCT00975806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00975806 about?
NCT00975806 is a clinical study titled "Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma". The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.
What is the current status of trial NCT00975806?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2009-09-01. Estimated completion is 2011-10-01.
What interventions are being tested in trial NCT00975806?
The interventions under investigation include: Lenalidomide (DRUG), Sunitinib (DRUG).
Who is sponsoring clinical trial NCT00975806?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00975806's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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