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NCT01111825 · ClinicalTrials.gov registry record · Phase 1
Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
A Phase 1 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT01111825: Completed Phase 1 study, sponsored by Puma Biotechnology.
NCT01111825 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01111825, a Phase 1 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease.
Primary Outcome
ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met.
Interventions
- DRUG Neratinib
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT01111825 record still lists
NCT01111825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Neratinib is the first listed.
NCT01111825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01111825 about?
NCT01111825 is a clinical study titled "Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer". This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced brea...
What is the current status of trial NCT01111825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2010-04. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01111825?
The interventions under investigation include: Neratinib (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01111825?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01111825's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 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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