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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: Completed Phase 1 study of Neoplasms and Malignant Carcinoma, sponsored by Puma Biotechnology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A DLT was defined as any dose-limiting Adverse Event related to neratinib + Temsirolimus as Grade 3 or higher nonhematologic toxicity (except neutropenia) or Grade 3 or higher diarrhea lasting \>2 days with optimal antidiarrheal therapy etc.
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 |
What the finished NCT00838539 record still lists
NCT00838539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower).
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 lists 5 locations in 2 states (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.
Learn More About Clinical Trials
Similar trials for Neoplasms
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 NCT00838539's enrollment target sits among peer trials
63 94th of 158 higher than 65 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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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