Clinical trial · Interventional
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
NCT00838539CI-TRIAL-00034930completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Carcinoma | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neratinib | Drug | Neratinib | ALIAS |
| Temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Neratinib and Temsirolimus (Dose level 1)
- description
- Neratinib 120 mg and Temsirolimus 15 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen
- interventionNames
- Drug: Neratinib
- Drug: Temsirolimus
- type
- EXPERIMENTAL
- label
- Neratinib and Temsirolimus (Dose level 2)
- description
- Neratinib 120 mg and Temsirolimus 25 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen
- interventionNames
- Drug: Neratinib
- Drug: Temsirolimus
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGandhi L, Bahleda R, Tolaney SM, Kwak EL, Cleary JM, Pandya SS, Hollebecque A, Abbas R, Ananthakrishnan R, Berkenblit A, Krygowski M, Liang Y, Turnbull KW, Shapiro GI, Soria JC. Phase I study of neratinib in combination with temsirolimus in patients with human epidermal growth factor receptor 2-dependent and other solid tumors. J Clin Oncol. 2014 Jan 10;32(2):68-75. doi: 10.1200/JCO.2012.47.2787. Epub 2013 Dec 9. PMID 24323026