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NCT01417065 · ClinicalTrials.gov registry record · Early Phase 1
Temsirolimus In Phase 0
A Early Phase 1 study of Advanced Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01417065: Completed Early Phase 1 study of Advanced Cancer, sponsored by M.D. Anderson Cancer Center.
NCT01417065 is a Early Phase 1 study of Advanced Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01417065, a Early Phase 1 study of Advanced Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested. The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.
Primary Outcome
PD response, significant S6 Kinase 1 (S6K1) inhibition, is defined at both the patient level and the dose level, 1) as compared with baseline, at least 50% reductions of S6K1 after treatment (biological criterion); 2) differences in log transformed S6K1 activity between post-treatment and baseline should be greater than threshold of 1.8 times standard deviation (SD) of baseline, which yields a 90% statistical confidence that it is not due to chance variation (statistical criterion).
Conditions Studied
Interventions
- DRUG Temsirolimus
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-08 |
| Phase | Early Phase 1 |
What the finished NCT01417065 record still lists
NCT01417065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 1 intervention - of which Temsirolimus is the first listed.
NCT01417065 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01417065 about?
NCT01417065 is a clinical study titled "Temsirolimus In Phase 0". The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from ...
What is the current status of trial NCT01417065?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2010-08.
What conditions does trial NCT01417065 study?
This clinical trial studies the following conditions: Advanced Cancer.
What interventions are being tested in trial NCT01417065?
The interventions under investigation include: Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01417065?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01417065 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
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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 NCT01417065's enrollment target sits among peer trials
15 116th of 122 higher than 6 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.
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