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NCT01596140 · ClinicalTrials.gov registry record · Phase 1
Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01596140: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01596140 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596140, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with either everolimus or temsirolimus. The safety of these drug combinations will also be studied. Vemurafenib is designed to block BRAF inside the cancer cells, which is a mutation that is involved in cancer cell growth. Temsirolimus and everolimus are designed to block the growth of cancer cells, which may cause cancer cells to die.
Primary Outcome
The MTD of combination Vemurafenib and Everolimus or Vemurafenib and Temsirolimus is defined as the highest dose studied in which the incidence of dose limiting toxicity (DLT) was less than one third (33%) of the participants at that dose level. DLT defined as any Grade 3 or 4 non-hematologic toxicity, as defined in NCI CTC v4.0, even if expected and believed related to study medications, any Grade 4 hematologic toxicity lasting two weeks or longer despite supportive care; Grade 3 nausea/vomitin
Interventions
- DRUG Everolimus
- DRUG Vemurafenib
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-12-18 |
| Est. Completion | 2020-06-01 |
| Phase | Phase 1 |
What the finished NCT01596140 record still lists
NCT01596140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Everolimus is the first listed.
NCT01596140 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596140 about?
NCT01596140 is a clinical study titled "Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer". The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with either everolimus or temsirolimus. The safety of these drug combinations will also be studied. Vemurafenib is designed to block BRAF inside the cancer cells, which is ...
What is the current status of trial NCT01596140?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2012-12-18. Estimated completion is 2020-06-01.
What interventions are being tested in trial NCT01596140?
The interventions under investigation include: Everolimus (DRUG), Vemurafenib (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01596140?
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 NCT01596140's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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