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NCT01529138 · ClinicalTrials.gov registry record · Phase 1
Study of Axitinib and Temsirolimus in Solid Tumors
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01529138: Completed Phase 1 study, sponsored by Emory University.
NCT01529138 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01529138, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment. The combination of the drugs temsirolimus and axitinib has not been studied before so it is unknown whether this treatment will have any benefit in the patient's cancer. Temsirolimus is commercially available and approved for treatment of some types of kidney cancer. Axitinib has been tested in several diseases but it is not yet commercially available for the treatment of any cancer in the United States. The combination of temsirolimus and axitinib is not approved for treatment of any cancer outside of a clinical trial.
Primary Outcome
Complete Response: Disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions.Note: the appearance of one or more new lesions is also considered progressions). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify
Interventions
- DRUG Axitinib
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01529138 record still lists
NCT01529138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Axitinib is the first listed.
NCT01529138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01529138 about?
NCT01529138 is a clinical study titled "Study of Axitinib and Temsirolimus in Solid Tumors". This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment. The combination of the drugs temsirolimus and axitinib has no...
What is the current status of trial NCT01529138?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-10. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01529138?
The interventions under investigation include: Axitinib (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01529138?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01529138's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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