Clinical trials: Olaparib, completed
Melanoma Neoplasms
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine
This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who have not previously received systemic cytotoxic…
- Trial name
- NCT00516802
- Testing
- KU-0059436 (AZD2281)(PARP inhibitor), dacarbazine
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Ovarian Cancer, Breast Cancer
Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer
A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic…
- Trial name
- SOLI (NCT04330040)
- Testing
- Olaparib
- Where
- 16 sites in India
- Volunteers
- 202 people
- Sponsor
- AstraZeneca
Pancreatic Neoplasms
LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)
To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual…
- Trial name
- NCT04889404
- Where
- 60 sites in Japan
- Volunteers
- 130 people
- Sponsor
- AstraZeneca
Solid Tumours
To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours
This is a 3-part study in patients with advanced solid tumours: Part A will assess the effect of itraconazole on the PK parameters of olaparib and will determine the effect of olaparib on the QT interval following single oral…
- Trial name
- NCT01900028
- Testing
- Pharmacokinetic sampling, Olaparib tablet dosing, Itraconazole
- Where
- 14 sites in Belgium, Denmark and 2 more
- Volunteers
- 85 people
- Sponsor
- AstraZeneca
Solid Tumours
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie…
- Trial name
- NCT01851265
- Testing
- Olaparib, Dietary Fasted, Dietary standard
- Where
- 7 sites in Belgium, Netherlands and 1 more
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Ovarian Cancer, Fallopian Tube Cancer
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
- Trial name
- NCT03740165
- Testing
- Pembrolizumab, Carboplatin, Paclitaxel
- Where
- 227 sites in United States, Australia and 20 more
- Volunteers
- 1,367 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer Metastatic, BRCA 1 Gene Mutation
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in…
- Conditions
- Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- OlympiAD (NCT02000622)
- Testing
- Olaparib, Physician's choice chemotherapy
- Where
- 171 sites in United States, Bulgaria and 17 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
Ovarian Cancer
Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)
[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use. 1. ADR development in actual clinical use 2. Factors which may affect safety and efficacy 3.
- Trial name
- NCT03505307
- Volunteers
- 846 people
- Sponsor
- AstraZeneca
Head and Neck Squamous Cell Carcinoma
A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).
This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies.
- Trial name
- NCT03022409
- Testing
- Ceralasertib, Olaparib
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 21 people
- Sponsor
- AstraZeneca
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Malignant Solid Tumors
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours
- Trial name
- NCT00516438
- Testing
- KU-0059436 (AZD2281)(PARP inhibitor), Topotecan
- Where
- 3 sites in United Kingdom
- Volunteers
- 48 people
- Sponsor
- AstraZeneca
Prostatic Neoplasms
Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants…
- Trial name
- KEYLYNK-010 (NCT03834519)
- Testing
- Pembrolizumab, Olaparib, Abiraterone acetate
- Where
- 193 sites in United States, Argentina and 18 more
- Volunteers
- 793 people
- Sponsor
- Merck Sharp & Dohme LLC
Ovarian Cancer, Prostate Cancer
Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients
This is a multi-centre, prospective, non-interventional study. The study will enrol about 860 Chinese cancer patients from around 56 sites.
- Trial name
- NCT04560452
- Where
- 37 sites in China
- Volunteers
- 1,018 people
- Sponsor
- AstraZeneca
Gastric Cancer
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line…
- Trial name
- NCT01924533
- Testing
- Olaparib, Paclitaxel
- Where
- 57 sites in China, Japan and 2 more
- Volunteers
- 525 people
- Sponsor
- AstraZeneca
Metastatic Castration-resistant Prostate Cancer
Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.
This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once…
- Trial name
- NCT01972217
- Testing
- Olaparib, Abiraterone, Prednisone or prednisolone
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 158 people
- Sponsor
- AstraZeneca
Solid Tumours
To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice…
- Trial name
- NCT02093351
- Testing
- Olaparib, Tamoxifen, Anastrozole
- Where
- 14 sites in Belgium, Denmark and 3 more
- Volunteers
- 79 people
- Sponsor
- AstraZeneca
Healthy Participants
Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects
This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days.
- Trial name
- NCT06360445
- Testing
- Olaparib Tablet test formulation 100mg, Olaparib Tablet reference formulation 100mg, Olaparib Tablet test formulation 150mg
- Where
- China
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
Breast Neoplasms
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer
The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no…
- Trial name
- ICEBERG 1 (NCT00494234)
- Testing
- Olaparib
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Advanced Solid Malignancies
Open Label, Dose Escalation Phase I Study of AZD2281
The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies
- Trial name
- NCT00572364
- Testing
- KU-0059436 (AZD2281)(PARP inhibitor)
- Where
- Japan
- Volunteers
- 18 people
- Sponsor
- AstraZeneca
Gastric Cancer
Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress…
- Trial name
- NCT01063517
- Testing
- olaparib, paclitaxel
- Where
- 7 sites in South Korea
- Volunteers
- 124 people
- Sponsor
- AstraZeneca