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NCT00838539 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
A Phase 1 study of Neoplasms and Malignant Carcinoma, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 5
- Study locations
NCT00838539 is a Phase 1 study of Neoplasms and Malignant Carcinoma that has completed, run by Puma Biotechnology. The registered enrollment target is 63 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 2 states.
The verdict
NCT00838539, a Phase 1 study of Neoplasms and Malignant Carcinoma, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.
Conditions Studied
Interventions
- DRUG Neratinib
- DRUG Temsirolimus
Study Locations (5)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Other
- Institut Gustave Roussy - Villejuif
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00838539
The ClinicalTrials.gov registry entry for NCT00838539 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Neratinib is the first listed.
NCT00838539 reports 5 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Other.
Frequently Asked Questions
What is clinical trial NCT00838539 about?
NCT00838539 is a clinical study titled "Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors". The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.
What is the current status of trial NCT00838539?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2009-04. Estimated completion is 2013-12.
What conditions does trial NCT00838539 study?
This clinical trial studies the following conditions: Neoplasms, Malignant Carcinoma.
What interventions are being tested in trial NCT00838539?
The interventions under investigation include: Neratinib (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT00838539?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00838539 being conducted?
This trial has 5 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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