Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00838539
• Date of registration: 05/02/2009
• Prospective Registration: Yes
• Primary sponsor: Puma Biotechnology, Inc.
• Public title: Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
• Scientific title: A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
• Date of first enrolment: April 2009
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00838539
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, United States

Contacts

• Name: Puma
• Affiliation: Biotechnology

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malignant Carcinoma

Neoplasms

Intervention(s)

Drug: Neratinib

Drug: Temsirolimus

Primary Outcome(s)

Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Neratinib [Time Frame: From first dose date to day 28]

Adverse Events Causing Dose Limiting Toxicities [Time Frame: From first dose date to day 21]

Maximum Tolerated Dose (MTD) of Neratinib in Combination With Temsirolimus [Time Frame: From first dose date to day 28]

Probability of Dose-Limiting Toxicity (DLT) [Time Frame: From first dose date to day 28]

Secondary Outcome(s)

Area Under the Curve Tau [Time Frame: Week 4]

Best Overall Response [Time Frame: From first dose date to progression/death or last tumor assessment, up to 30 months]

Clinical Benefit Rate [Time Frame: From first dose date to progression/death or last tumor assessment, up to 30 months]

Objective Response Rate [Time Frame: From first dose date to progression/death or last tumor assessment, up to 30 months]

Secondary ID(s)

3144A1-2205 / B1891016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/02/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00838539