A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms, Malignant Carcinoma
Both
Neoplasms, Malignant Carcinoma
Trial Information
A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
Inclusion Criteria:
- Pathologic diagnosis of advanced or metastatic solid tumor.
- Measurable disease per Response Criteria in Solid Tumors (RECIST criteria).
- Incurable cancer, with disease progression following at least 1 conventional or
standard therapy for locally advanced or metastatic disease.
- Negative pregnancy test for women of child bearing potential.
Exclusion Criteria:
- Chronic treatment with corticosteroids.
- Primary central nervous system (CNS) tumors and active metastases.
- Presence of clinically significant or uncontrolled cardiac disease.
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a
major symptom.
- Symptomatic or prior history of non-infectious interstitial pneumonitis.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the Maximum Tolerated Dose (MTD) toxicity contour of the combination of neratinib and temsirolimus.
Outcome Time Frame:
Approximately 12 months
Safety Issue:
Yes
Principal Investigator
Puma
Investigator Role:
Study Director
Investigator Affiliation:
Biotechnology
Authority:
United States: Food and Drug Administration
Study ID:
3144A1-2205
NCT ID:
NCT00838539
Start Date:
April 2009
Completion Date:
October 2012
Related Keywords:
- Neoplasms
- Malignant Carcinoma
- Neratinib in combination with Temsirolimus
- solid tumors
- phase 1
- dose finding study
- Neoplasms
- Carcinoma
Name | Location |
|---|---|
| Investigational Site | Boston, Massachusetts 02118 |
