Phase I AZD2281/Cisplatin in Advanced Solid Tumour participants
Study identifier:D0810C00021
ClinicalTrials.gov identifier:NCT00782574
EudraCT identifier:2008-000062-24
CTIS identifier:N/A
Study Complete
Official Title
A Phase I Open label, Multi centre study of AZD2281 Administered Orally in combination With Cisplatin, to assess the Safety and Tolerability in Patients with Advanced Solid Tumours
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD2281, Cisplatin
Sex
All
Actual Enrollment
57
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 12 Nov 2008
Primary Completion Date: 01 Feb 2012
Study Completion Date: 07 Dec 2023
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1: Continuous Dosing Participants will receive oral olaparib capsule 50 mg once on Study Day 1 and thereafter will receive combination therapy of oral olaparib capsule 50 mg twice daily (BID) and intravenous (IV) cisplatin infusion 75 mg/m^2 on Day 1 (Study Day 8) of 21-day cycle. Participants will continue receiving oral olaparib 50 mg BID until Day 21 of the cycle. Participants will continue receiving combination therapy until Cycle 6 or until they receive benefit and are free from significant toxicity. Post cisplatin discontinuation after Cycle 6, participants will continue receiving oral olaparib capsule 400 mg BID (monotherapy phase) at the investigator’s discretion until participants receive benefit or not met disease progression or any other discontinuation criteria. | Drug: AZD2281 Participants will receive oral olaparib capsule as stated in arm description. Other Name: Olaparib; Lynparza Drug: Cisplatin Participants will receive IV infusion of cisplatin as stated in arm description. |
| Experimental: Cohort 2: Continuous Dosing Participants will receive oral olaparib capsule 100 mg once on Study Day 1 and thereafter will receive combination therapy of oral olaparib capsule 100 mg twice daily (BID) and intravenous (IV) cisplatin infusion 75 mg/m^2 on Day 1 (Study Day 8) of 21-day cycle. Participants will continue receiving oral olaparib 100 mg BID until Day 21 of the cycle. Participants will continue receiving combination therapy until Cycle 6 or until they receive benefit and are free from significant toxicity. Post cisplatin discontinuation after Cycle 6, participants will continue receiving oral olaparib capsule 400 mg BID (monotherapy phase) at the investigator’s discretion until participants receive benefit or not met disease progression or any other discontinuation criteria. | Drug: AZD2281 Participants will receive oral olaparib capsule as stated in arm description. Other Name: Olaparib; Lynparza Drug: Cisplatin Participants will receive IV infusion of cisplatin as stated in arm description. |
| Experimental: Cohort 3: Continuous Dosing Participants will receive oral olaparib capsule 200 mg once on Study Day 1 and thereafter will receive combination therapy of oral olaparib capsule 200 mg twice daily (BID) and intravenous (IV) cisplatin infusion 75 mg/m^2 on Day 1 (Study Day 8) of 21-day cycle. Participants will continue receiving oral olaparib 200 mg BID until Day 21 of the cycle. Participants will continue receiving combination therapy until Cycle 6 or until they receive benefit and are free from significant toxicity. Post cisplatin discontinuation after Cycle 6, participants will continue receiving oral olaparib capsule 400 mg BID (monotherapy phase) at the investigator’s discretion until participants receive benefit or not met disease progression or any other discontinuation criteria. | Drug: AZD2281 Participants will receive oral olaparib capsule as stated in arm description. Other Name: Olaparib; Lynparza Drug: Cisplatin Participants will receive IV infusion of cisplatin as stated in arm description. |
| Experimental: Cohort 4: Intermittent Dosing Participants will receive oral olaparib capsule 100 mg BID on Days 1 to 10 and IV cisplatin infusion 75 mg/m^2 on Day 1 of 21-day cycle. Participants will continue receiving combination therapy until Cycle 6 or until they receive benefit and are free from significant toxicity. Post cisplatin discontinuation after Cycle 6, participants will continue receiving oral olaparib capsule 400 mg BID (monotherapy phase) at the investigator’s discretion until participants receive benefit or not met disease progression or any other discontinuation criteria. | Drug: AZD2281 Participants will receive oral olaparib capsule as stated in arm description. Other Name: Olaparib; Lynparza Drug: Cisplatin Participants will receive IV infusion of cisplatin as stated in arm description. |
| Experimental: Cohort 5: Intermittent Dosing Participants will receive oral olaparib capsule 50 mg BID on Days 1 to 10 and IV cisplatin infusion 75 mg/m^2 on Day 1 of 21-day cycle. Participants will continue receiving combination therapy until Cycle 6 or until they receive benefit and are free from significant toxicity. Post cisplatin discontinuation after Cycle 6, participants will continue receiving oral olaparib capsule 400 mg BID (monotherapy phase) at the investigator’s discretion until participants receive benefit or not met disease progression or any other discontinuation criteria. | Drug: AZD2281 Participants will receive oral olaparib capsule as stated in arm description. Other Name: Olaparib; Lynparza Drug: Cisplatin Participants will receive IV infusion of cisplatin as stated in arm description. |
| Experimental: Cohort 6: Intermittent Dosing Participants will receive oral olaparib capsule 50 mg BID on Days 1 to 10 and IV cisplatin infusion 60 mg/m^2 on Day 1 of 21-day cycle. Participants will continue receiving combination therapy until Cycle 6 or until they receive benefit and are free from significant toxicity. Post cisplatin discontinuation after Cycle 6, participants will continue receiving oral olaparib capsule 400 mg BID (monotherapy phase) at the investigator’s discretion until participants receive benefit or not met disease progression or any other discontinuation criteria. | Drug: AZD2281 Participants will receive oral olaparib capsule as stated in arm description. Other Name: Olaparib; Lynparza Drug: Cisplatin Participants will receive IV infusion of cisplatin as stated in arm description. |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
