NCT01548482

Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

A Phase I Trial of AMG 386 and Temsirolimus in Advanced Solid Tumors With an Expansion Cohort in Uterine Cancer, Renal Cell Carcinoma and Carcinoid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and the best dose of trebananib and temsirolimus when given together in treating patients with solid tumors that are metastatic or cannot be removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trebananib with temsirolimus may be an effective treatment for solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) and safety profile of AMG 386 (trebananib) in combination with temsirolimus in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To evaluate pharmacodynamic (PD) effects of both drugs when administered in combination, with the goal of identifying potential predictive and PD markers that need further exploration and validation in future trials. II. To explore preliminary anti-tumor activity of both drugs when administered at the RP2D to patients with advanced endometrial cancer, renal cell carcinoma, or carcinoid tumor. OUTLINE: This is a dose-escalation study of trebananib. Patients receive trebananib intravenously (IV) over 60 minutes and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Adult Solid Neoplasm
• Lung Carcinoid Tumor
• Recurrent Digestive System Neuroendocrine Tumor G1
• Recurrent Renal Cell Carcinoma
• Recurrent Uterine Corpus Sarcoma
• Stage III Renal Cell Cancer
• Stage IIIB Uterine Sarcoma
• Stage IIIC Uterine Sarcoma
• Stage IV Renal Cell Cancer
• Stage IVA Uterine Sarcoma
• Stage IVB Uterine Sarcoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Temsirolimus	Given IV
BIOLOGICAL	Trebananib	Given IV

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-03-08
• Last updated: 2015-10-06

Locations

3 sites across 1 country: Canada