AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors

Conditions

• Refractory Solid Tumours
• Relapsed Small Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• AZD1775 — DRUG
  AZD1775 will be given twice daily (PO BID) over 3 days (6 doses) on Days 1-3 and 8-10 of each 21 day cycle combined with olaparib PO BID on Days 1-14 of each 21 day cycle. Olaparib will be given orally BID on Days 1-14.
• Olaparib — DRUG
  AZD1775 will be given twice daily (PO BID) over 5 days (10 doses) on Days 1-5 and 8-12 of each 21 day cycle combined with olaparib PO BID on Days 1-14 of each 21 day cycle. Olaparib will be given orally BID on Days 1-14.

Study Details

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

Key Dates

Start date

Aug 6, 2015

Status verified

Nov 2019

Primary completion

Apr 25, 2019

Completion

Oct 16, 2019

Study Design

Enrollment

128 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AZD1775 (6 doses/week) + Olaparib
  In this Arm, AZD1775 will be given twice daily over 3 days (6 doses) on Days 1-3 of Week 1 and Days 8-10 of Week 2. Olaparib will be given orally BID on Days 1-14. All patients will enter an olaparib sub-study in order to assess multiple dose pharmacokinetics of olaparib prior to entering the main study. In the olaparib PK sub-study patients will take olaparib for 3 consecutive days and venous blood samples will be collected on Day 3. The PK sub-study must be initiated 10 days prior to the Cycle 1 Day 1 administration of the AZD1775 and olaparib combination. The patient will experience a short gap in treatment (approximately 4-5 days) between Day 3 of the olaparib PK sub-study and Cycle 1 Day 1 AZD1775 and olaparib combined dosing.
• Experimental: AZD1775 (10 doses/week) + Olaparib
  In this Arm, AZD1775 will be given twice daily over 5 days (10 doses) on Days 1-5 of Week 1 and Days 8-12 of Week 2. Olaparib will be given orally BID on Days 1-14. All patients will enter an olaparib sub-study in order to assess multiple dose pharmacokinetics of olaparib prior to entering the main study. In the olaparib PK sub-study patients will take olaparib for 3 consecutive days and venous blood samples will be collected on Day 3. The PK sub-study must be initiated 10 days prior to the Cycle 1 Day 1 administration of the AZD1775 and olaparib combination. The patient will experience a short gap in treatment (approximately 4-5 days) between Day 3 of the olaparib PK sub-study and Cycle 1 Day 1 AZD1775 and olaparib combined dosing.

Primary Outcome Measure

Part A: The incidence of dose-limiting toxicities (DLTs) [ Time Frame: 21 days (Cycle 1 duration) ]

Locations (5)

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