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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 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 99 participants.
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.
Interventions
- DRUG Neratinib
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01111825
The ClinicalTrials.gov registry entry for NCT01111825 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Neratinib is the first listed.
NCT01111825 reports 0 study locations.
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.
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