CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 63 enrolled
Drug / intervention
Neratinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00838539
NCT00838539Phase 1Completed

A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Puma Biotechnology, Inc.·interventional·Posted Feb 6, 2009·Updated Sep 18, 2018

In Brief

A Phase 1 clinical trial evaluating Neratinib and Temsirolimus for Neoplasms and Malignant Carcinoma. Completed, enrolled 63 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2009
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2011
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.4 years ago

Interventions

Neratinibdrug

Temsirolimusdrug