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NCT01529593 · ClinicalTrials.gov registry record · Phase 1
Temsirolimus in Combination With Metformin in Patients With Advanced Cancers
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01529593: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01529593 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01529593, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of temsirolimus and metformin hydrochloride in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced or metastatic). Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Metformin hydrochloride is a drug used to treat diabetes that may also prevent or slow the growth of cancers. Giving temsirolimus and metformin hydrochloride together may kill more tumor cells.
Primary Outcome
MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33%. DLTs defined as adverse events (AEs) related to study agents which occur during first cycle of treatment. Toxicity must have possible, probable or definite attribution to study drugs.
Interventions
- DRUG Metformin
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-03-26 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 1 |
Why NCT01529593 stopped before completion
NCT01529593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT01529593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01529593 about?
NCT01529593 is a clinical study titled "Temsirolimus in Combination With Metformin in Patients With Advanced Cancers". This phase I trial studies the side effects and best dose of temsirolimus and metformin hydrochloride in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced or metastatic). Temsirolimus may stop the growth of tu...
What is the current status of trial NCT01529593?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-03-26. Estimated completion is 2025-03-14.
What interventions are being tested in trial NCT01529593?
The interventions under investigation include: Metformin (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01529593?
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 NCT01529593's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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