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NCT01087554 · ClinicalTrials.gov registry record · Phase 1
Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer
A Phase 1 study of Advanced Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 249
- Enrollment target
- 1
- Study location
NCT01087554: Active Phase 1 study of Advanced Cancer, sponsored by M.D. Anderson Cancer Center.
NCT01087554 is a Phase 1 study of Advanced Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 249 participants, roughly in line with the 244-participant average among 122 other Advanced Cancer trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087554, a Phase 1 study of Advanced Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 249 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination vorinostat given in combination with either sirolimus, everolimus or temsirolimus that can be given to patients with advanced cancer. The safety of this drug combination will also be studied. The Study Drugs: Vorinostat is designed to prevent or slow down the growth of cancer cells by blocking proteins. Everolimus is designed to stop cells from dividing. This may stop or slow the growth or spread of cancer cells. Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread of cancer cells or possibly kill them. Sirolimus is designed to block a protein called mTOR inside the cancer cell. This may interfere with the growth or spread of cancer cells or possibly kill the cancer cells. This is an investigational study. Sirolimus is FDA approved and commercially available as an anti-rejection drug for kidney transplant recipients. Everolimus is FDA-approved and commercially available for the treatment of pancreatic neuroendocrine tumor, subependymal giant cell astrocytoma, and renal cell carcinoma. Temsirolimus is FDA approved and commercially available for the treatment of renal cell carcinoma. Vorinostat is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma. The combination of these drugs is investigational. Up to 249 patients will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
Maximum tolerated dose (MTD) defined by dose-limiting toxicities (DLTs) that 1) occur during the first four weeks of therapy, 2) are related to the study medications (attributions: possible, probable, and likely) and 3) fulfill one of the following criteria (as graded by the NCI Common Terminology Criteria for Adverse Events). MTD is defined as highest dose level in which 6 patients have been treated with less than 2 DLTs.
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Everolimus
- DRUG Vorinostat
- DRUG Temsirolimus
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2010-03 |
| Est. Completion | 2026-08-18 |
| Phase | Phase 1 |
What the registry record for NCT01087554 still lists
NCT01087554 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 244-participant average among 122 other Advanced Cancer trials with a reported enrollment target.
The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 4 interventions - of which Sirolimus is the first listed.
NCT01087554 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01087554 about?
NCT01087554 is a clinical study titled "Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer". The goal of this clinical research study is to find the highest tolerable dose of the combination vorinostat given in combination with either sirolimus, everolimus or temsirolimus that can be given to patients with advanced cancer. The safety of this drug combination will also be studied. The Study...
What is the current status of trial NCT01087554?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 249 participants. The study started on 2010-03. Estimated completion is 2026-08-18.
What conditions does trial NCT01087554 study?
This clinical trial studies the following conditions: Advanced Cancer.
What interventions are being tested in trial NCT01087554?
The interventions under investigation include: Sirolimus (DRUG), Everolimus (DRUG), Vorinostat (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01087554?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01087554 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01087554's enrollment target sits among peer trials
249 27th of 122 higher than 96 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer 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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