Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-03 @ 8:15 PM
Study NCT ID:
NCT02511795
Status:
COMPLETED
Last Update Posted:
2019-11-07
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase Ib Study of AZD1775 and Olaparib in Patients With Refractory Solid Tumours
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03079687
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| REFMAL 384 | OTHER | Sarah Cannon Development Innovations, LLC | View |