Onalespib and CDKI AT7519 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 37
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
- Unresectable Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To establish the safety, tolerability, and the maximum tolerated dose of the combination of onalespib and AT7519M (CDKI AT7519). SECONDARY OBJECTIVES: I. To determine the pharmacokinetics of the combination of onalespib and AT7519M. II. To assess the pharmacodynamic effect of ...
PRIMARY OBJECTIVES: I. To establish the safety, tolerability, and the maximum tolerated dose of the combination of onalespib and AT7519M (CDKI AT7519). SECONDARY OBJECTIVES: I. To determine the pharmacokinetics of the combination of onalespib and AT7519M. II. To assess the pharmacodynamic effect of the combination of onalespib and AT7519M on HSP70 expression and modulation of HSP90 client proteins in peripheral blood mononuclear cells (PBMCs), plasma, and tumor biopsies. III. To observe and record anti-tumor activity. OUTLINE: This is a dose-escalation study. Patients receive onalespib intravenously (IV) over 1 hour on days 1 and 4 (cycle 0 only). Patients then receive onalespib IV over 1 hour and CDKI AT7519 IV over 1 hour on days 1, 4, 8, and 11 (cycle 1 and subsequent cycles thereafter). Cycles repeat every 21 days (7 days for course 0 only) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Tracking Information
- NCT #
- NCT02503709
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Khanh T Do Dana-Farber - Harvard Cancer Center LAO