Trials / Completed
CompletedNCT00838539
Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Puma Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Neratinib | |
| DRUG | Temsirolimus |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2011-06-01
- Completion
- 2013-12-01
- First posted
- 2009-02-06
- Last updated
- 2018-09-18
- Results posted
- 2018-02-26
Locations
5 sites across 2 countries: United States, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00838539. Inclusion in this directory is not an endorsement.