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NCT01183663 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT01183663: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01183663 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 180 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01183663, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Primary Outcome
If more than 33% of patients enrolled in any particular dose level develop dose limiting toxicity (DLT), treatment will continue at dose level immediately below. If not more than 33% of patients in cohort develop DLT, this cohort considered the MTD. DLT defined as any Grade 3 or 4 non-hematologic toxicity, as defined in most current version of NCI CTCAE, even if expected and believed related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regim
Interventions
- DRUG Bevacizumab
- DRUG Lenalidomide
- DRUG Sorafenib
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2010-08 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT01183663 record still lists
NCT01183663 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher).
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT01183663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01183663 about?
NCT01183663 is a clinical study titled "Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)". The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
What is the current status of trial NCT01183663?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2010-08. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01183663?
The interventions under investigation include: Bevacizumab (DRUG), Lenalidomide (DRUG), Sorafenib (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01183663?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01183663's enrollment target sits among peer trials
180 299th of 2000 higher than 1,690 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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