Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
- Unresectable Malignant 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 OBJECTIVE: I. To evaluate the safety and establish the recommended phase 2 dose (RP2D) of the doublet combination of copanlisib and olaparib and of the triplet combination of copanlisib, olaparib and MEDI4736 (durvalumab) in patients with molecularly-selected solid tumors. SECONDARY OBJECTIV...
PRIMARY OBJECTIVE: I. To evaluate the safety and establish the recommended phase 2 dose (RP2D) of the doublet combination of copanlisib and olaparib and of the triplet combination of copanlisib, olaparib and MEDI4736 (durvalumab) in patients with molecularly-selected solid tumors. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity of the doublet combination of copanlisib and olaparib, and of the triplet combination of copanlisib, olaparib and MEDI4736 (durvalumab) in patients with molecularly-selected advanced solid tumors, as measured by objective response rate (ORR) (complete response [CR] + partial response [PR]). Although the clinical benefit of the doublet and triplet combination of these drugs has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. II. To assess overall duration of response (DoR), progression free survival (PFS) and overall survival (OS). III. To assess the pharmacokinetic (PK) profiles of these combinations, and explore exposure-response relationships. IV. To correlate molecular alterations with OR (CR+PR). OUTLINE: This is a dose-escalation study of copanlisib and olaparib. Patients receive copanlisib hydrochloride intravenously (IV) over 1 hour on days 1, 8, and 15 and olaparib orally (PO) twice daily (BID). Beginning cycle 2, patients receive durvalumab IV over 1 hour on day 1. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3-6 months for up to 2 years.
Tracking Information
- NCT #
- NCT03842228
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Timothy A Yap University of Texas MD Anderson Cancer Center LAO
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