Clinical trials: BRCA Mutation
Metastatic Triple Negative Breast Cancer
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and…
- Trial name
- NCT03330847
- Testing
- Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle)., Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).
- Where
- 141 sites in United States, Belgium and 13 more
- Volunteers
- 273 people
- Sponsor
- AstraZeneca
Breast Neoplasms, BRCA 1 Gene Mutation
A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or…
- Conditions
- Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- ABRAZO (NCT02034916)
- Testing
- talazoparib
- Where
- 71 sites in United States, France and 3 more
- Volunteers
- 84 people
- Sponsor
- Pfizer
Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at…
- Trial name
- SOLO3 (NCT02282020)
- Testing
- OLAPARIB, Single agent chemotherapy
- Where
- 94 sites in United States, Argentina and 11 more
- Volunteers
- 266 people
- Sponsor
- AstraZeneca
Platinum Sensitive, BRCA Mutated
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with…
- Conditions
- Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy
- Trial name
- NCT01874353
- Testing
- Olaparib 300mg tablets
- Where
- 126 sites in United States, Australia and 15 more
- Volunteers
- 327 people
- Sponsor
- AstraZeneca
Cancer of Ovary, Pancreatic Ductal Adenocarcinoma
Promitil Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After Therapy
This multicenter Phase 2a study was designed to evaluate the safety, tolerability, and efficacy of Promitil in patients with recurrent ovarian cancer and inoperable, locally advanced or metastatic pancreatic cancer, which bears…
- Trial name
- NCT06478862
- Testing
- Promitil
- Where
- 6 sites in Israel
- Volunteers
- 19 people
- Sponsor
- Lipomedix Pharmaceuticals Inc.
Newly Diagnosed, Advanced Ovarian Cancer
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
- Conditions
- Newly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV, BRCA Mutation
- Trial name
- SOLO-1 (NCT01844986)
- Testing
- Olaparib 300mg tablets
- Where
- 177 sites in United States, Australia and 13 more
- Volunteers
- 450 people
- Sponsor
- AstraZeneca
Ovarian Cancer
A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer
This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated…
- Trial name
- NCT07069335
- Testing
- Olaparib 150 MG
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Advanced Solid Cancer, Metastatic Solid Tumor
Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors
This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors
- Conditions
- Advanced Solid Cancer, Metastatic Solid Tumor, Ovarian Cancer, Breast Cancer
- Trial name
- NCT07088588
- Testing
- SYN608
- Where
- 2 sites in China
- Volunteers
- 105 people
- Sponsor
- Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd
Ovarian Cancer
Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
The objective of this study was to evaluate the efficacy and safety of alpelisib in combination with olaparib compared with single-agent cytotoxic chemotherapy in participants with platinum-resistant or platinum-refractory…
- Trial name
- NCT04729387
- Testing
- Alpelisib, Olaparib, Paclitaxel
- Where
- 93 sites in United States, Argentina and 24 more
- Volunteers
- 358 people
- Sponsor
- Novartis Pharmaceuticals
Recurrent Platinum Resistant Ovarian Cancer
Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer
This is an open label, single arm, multi-center study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade serous, high grade endometroid or clear cell…
- Trial name
- CONCERTO (NCT02889900)
- Testing
- cediranib and olaparib
- Where
- 25 sites in United States
- Volunteers
- 62 people
- Sponsor
- AstraZeneca
Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound, Triple Negative Breast Cancer (TNBC)
Expanded Access to Veliparib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to veliparib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound, Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Cancer, Patients Requiring Veliparib Suspension Formulation
- Trial name
- NCT03123211
- Testing
- Veliparib
- Sponsor
- AbbVie
Ovarian Carcinoma, Breast Cancer
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to…
- Trial name
- NCT00679783
- Testing
- AZD2281
- Where
- 6 sites in Canada
- Volunteers
- 99 people
- Sponsor
- AstraZeneca
Ovarian Cancer, Breast Cancer
A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer
This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
- Trial name
- NCT05258747
- Testing
- Olaparib tablets, 150 mg, Lynparza® (olaparib) tablets 150 mg
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Sandoz
Germline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the Pancreas
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum…
- Trial name
- POLO (NCT02184195)
- Testing
- Olaparib
- Where
- 103 sites in United States, Australia and 10 more
- Volunteers
- 154 people
- Sponsor
- AstraZeneca
Solid Cancers, BRCA Mutation
A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway
The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss of function…
- Conditions
- Solid Cancers, BRCA Mutation, HRD Cancer, Breast Cancer
- Trial name
- NCT06614751
- Testing
- DAT-2645 tablet
- Where
- 2 sites in China
- Volunteers
- 112 people
- Sponsor
- Danatlas Pharmaceuticals Co., Ltd
Ovarian Cancer
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between…
- Trial name
- NCT06433219
- Testing
- Tuvusertib (M1774), Niraparib, Lartesertib (M4076)
- Where
- 84 sites in United States, Australia and 11 more
- Volunteers
- 63 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cancer, Ovarian Cancer
Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade…
- Trial name
- NCT07371104
- Testing
- DWZ2501 (Olaparib 150mg), DWC202510 (Olaparib 150mg)
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Advanced Ovarian Cancer
A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.
- Trial name
- FLAME (NCT05775549)
- Testing
- None (Observational Study)
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA…
- Trial name
- NCT04296370
- Testing
- Fluzoparib; Apatinib, Fluzoparib, Physician's choice chemotherapy
- Where
- China
- Volunteers
- 474 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Triple Negative Breast Cancer, Natural Killer Cells
A Pilot Surveillance Study to Monitor Natural Killer Cells and Circulating Tumor Cells in Women With Previously Treated Non-metastatic Triple Negative Breast Cancer and Women With Previously Treated Non-metastatic Breast Cancer With a Confirmed BRCA Mutation.
The purpose of this research study is: To test blood for the presence of tumor derived circulating tumor cells (CTCs) or circulating tumor DNA (ctDNA) using an investigational medical device called the LiquidBiopsy®.
- Conditions
- Triple Negative Breast Cancer, Natural Killer Cells, BRCA Mutation
- Trial name
- NCT02639832
- Testing
- LiquidBiopsy®, NK VueTM
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Cynvenio Biosystems