Phase 1
Completed N=63
Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
Neoplasms · Malignant Carcinoma
Source: ClinicalTrials.gov NCT00838539 ↗
Enrolled (actual)
63
Serious AEs
52.4%
Results posted
Feb 2018
Primary outcomePrimary: Probability of Dose-Limiting Toxicity (DLT) — 0; 12.5; 12.5; 50 percent probability
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Dose-Limiting Toxicity (DLT) |
0; 12.5; 12.5; 50; 13.63; 13.64 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Neratinib in Combination With Temsirolimus |
200 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Neratinib |
50 | — |
| PRIMARY Adverse Events Causing Dose Limiting Toxicities |
0; 1; 1; 0; 1; 1 | — |
| SECONDARY Best Overall Response |
1; 0; 1; 0; 1; 3 | — |
| SECONDARY Clinical Benefit Rate |
38.5; 27.8; 20.0; 25.0 | — |
| SECONDARY Objective Response Rate |
15.4; 16.7; 20.0; 25.0 | — |
| SECONDARY Area Under the Curve Tau |
390.65; 621.20; 408.98; 477.37; 1146.53; 775.89 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00838539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.