Study identifier:D6010C00005
ClinicalTrials.gov identifier:NCT02511795
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase Ib Study of AZD1775 and Olaparib in Patients with Refractory Solid Tumours
Refractory Solid Tumours
Phase 1
No
AZD1775, Olaparib
All
128
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Oct 2021 by AstraZeneca
AstraZeneca
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The purpose of this Phase 1b, multi-centre, dose escalation study is to find the maximum tolerated dose (MTD) of AZD1775 combined with olaparib in patients with refractory solid tumours
This is a Phase Ib, multi-centre study of AZD1775 combined with olaparib administered orally in patients with refractory solid tumours, or as combination therapy for relapsed small-cell lung cancer (SCLC). There are 2 parts to the study: Part A: Dose Escalation Part B: Dose Expansion In Part A, patients with refractory solid tumours will be assessed for safety, tolerability, and pharmacokinetics (PK) of AZD 1775 when combined with olaparib. Different dose levels will be administered to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D). The dose expansion part (Part B) will further explore the safety, PK, and preliminary efficacy of the AZD1775 RP2D and dosing schedule for the treatment of patients with SCLC who previously had a confirmed response (either a Complete Response or Partial Response) to first-line platinum therapy and then relapsed. Patients who progressed whilst on platinum-containing therapy (platinum refractory) are not permitted to enter the study.. An olaparib pharmacokinetic (PK) sub-study will precede the combined treatment with AZD1775 and olaparib for all patients in Part A. In the sub-study single agent olaparib will be given orally BID for 3 or 5 consecutive days and venous blood samples will be collected on Day 3 or Day 5 as appropriate for assessment of the multiple dose pharmacokinetics of single agent olaparib. Patients will experience a short gap in treatment (approximately 4-5 days) between Day 3 or Day 5 of the olaparib PK sub-study and Cycle 1 Day 1 of the combination treatment. Patients will continue to receive treatment with AZD1775 and Olaparib until disease progression, intolerable toxicity, or discontinuation criteria have been met.
Location
Location
Nashville, TN, United States, 37203
Location
Sarasota, FL, United States, 34232
Location
Denver, CO, United States, 80218
Location
Houston, TX, United States, 77030
Location
New York, NY, United States, 10033
Location
Toronto, ON, Canada, M5G 2M9
Arms | Assigned Interventions |
---|---|
Experimental: Part A: AZD1775 + Olaparib in solid tumors Patients received 125mg, 150mg, or 175mg AZD1775 twice daily (BID) for 3 Days & 100mg olaparib BID, both for 2 weeks; 150mg or 175mg AZD1775 BID for 3 Days & 200mg olaparib BID, both for 2 weeks; 175mg AZD1775 BID for 3 Days for 3 weeks & 200mg olaparib BID for 3 weeks; 175mg AZD1775 BID for 3 Days for 2 weeks & 200mg olaparib BID for 3 weeks; 175mg AZD1775 BID for 3 Days & 300mg olaparib BID, both for 2 weeks; 200mg or 250mg AZD1775 once daily (QD) for 5 Days for 2 weeks & 200mg olaparib BID for 3 weeks; 250mg AZD1775 QD for 3 Days for 2 Weeks & 200mg olaparib BID for 3 weeks; 250mg AZD1775 QD for 3 Days & 200mg olaparib BID, both for 3 weeks; 300mg AZD1775 QD for 3 Days x 2 Weeks & 300mg olaparib BID for 3 weeks; or 200mg AZD1775 QD for 3 Days x 2 Weeks & 200mg or 300mg olaparib BID for 3 weeks | Drug: AZD1775 AZD1775 will be given orally, daily over 3-5 days as part of a 21 day cycle. Other Name: adavosertib Drug: Olaparib Olaparib will be given daily, orally as part of a 21 day cycle Other Name: Lynparza |
Experimental: Part B: AZD1775 + Olaparib in small cell lung cancer AZD1775 200mg/Olaparib 200mg (AZD1775 QD 3/4 days x 2 weeks, Olaparib BID days 1-21) in patients with relapsed small cell lung cancer. | Drug: AZD1775 AZD1775 will be given orally, daily over 3-5 days as part of a 21 day cycle. Other Name: adavosertib Drug: Olaparib Olaparib will be given daily, orally as part of a 21 day cycle Other Name: Lynparza |
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