Clinical Trials Logo

Clinical Trial Summary

This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours. Part A will assess the single and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2


Clinical Trial Description

Part A will access the pharmacokinetics of olaparib: Cohort 1 will investigate the single and multiple dose pharmacokinetics of olaparib following 300mg bd monotherapy dose(s); Cohort 2 will investigate the single and multiple dose pharmacokinetics of olaparib following 100mg bd monotherapy dose(s) and the multiple dose pharmacokinetics in the presence of co-administered paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle).

In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in combination with weekly paclitaxel will also be investigated in Chinese patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02430311
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date June 10, 2015
Completion date April 28, 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05514132 - A Study to Evaluate the Safety and Pharmacokinetics of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours Phase 1
Terminated NCT04949425 - A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours Phase 1
Not yet recruiting NCT05537051 - A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours Phase 1
Completed NCT02579226 - A Phase I Study of Safety, Tolerability, and PK of AZD2811 in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT01668550 - A Phase I Study of AZD0424 Alone and in Combination in Advanced Solid Tumours Phase 1
Completed NCT01058538 - A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours Phase 1/Phase 2
Completed NCT02588105 - Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer Phase 1
Recruiting NCT03852823 - Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours Phase 1
Not yet recruiting NCT06380816 - A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer Phase 1/Phase 2
Completed NCT01585701 - Phase I Study of AT13148, a Novel AGC Kinase Inhibitor Phase 1
Completed NCT03101839 - Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid Tumours Phase 1
Completed NCT03150368 - Extended Use of ModraDoc006/r Phase 1
Active, not recruiting NCT02389842 - PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib Phase 1
Terminated NCT01581060 - Phase I/II Dose-escalation Study to Investigate Safety and Pharmacokinetics/ Pharmacodynamics of WX-554 in Patients With Solid Tumours Phase 1/Phase 2
Terminated NCT04959266 - A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib Phase 1
Completed NCT04462952 - Study of Adavosertib(AZD1775) in Japanese Patients With Advanced Solid Tumours Phase 1
Active, not recruiting NCT03518606 - Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours Phase 1/Phase 2
Terminated NCT01859351 - Phase I Study of WX-037 Alone and in Combination With WX-554 in Solid Tumours Phase 1
Completed NCT01163903 - Pantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours Phase 1
Recruiting NCT05804526 - A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours Phase 1/Phase 2