Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Subjects will receive a regimen of Olaparib tablets 300 mg twice daily until radiographic disease progression (assessed by the investigator according to RECIST1.1 and PCWG 3) or intolerable adverse events (assessed by the investigator according to the actual clinical situation).

Lynparza (Olaparib tablets) 300 mg should be taken orally twice daily

Hao Liu

This is a multi-center, single-arm, prospective study to assess the efficacy and safety of Olaparib in men with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) who carried homologous recombination repair (HRR) gene mutations and have progressed after treatment with novel endocrine agents (NHA) in the metastatic castration-sensitive prostate cancer or non-metastatic castration-resistant prostate cancer.

A total of 30 newly diagnosed mCRPC subjects with radiologically evaluable disease at baseline who have progressed on prior NHA and carry HRR gene mutations that meet the criteria will be included in the study. Eligible subjects will receive a treatment regimen of oral Olaparib tablets 300 mg twice daily until disease progression or intolerance. During the treatment and follow-up periods, all subjects will have regular visits to assess the efficacy and safety of Olaparib. Data on objective radiographic response (ORR), prostate-specific antigen response (PSA response), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) will be collected during the study.

The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation

A Multi-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Monotherapy in Newly Diagnosed mCRPC Patients Who Progressed on NHA and With HRR Gene Mutation

To explore the concordance rate of tissue samples and plasma ct-DNA samples by second-generation sequencing (NGS) testing

-Concordance rate between tissue and plasma ct-DNA testing results

1. To assess the efficacy of Olaparib in newly diagnosed metastatic castration-resistant prostate cancer with mutations in homologous recombination repair genes that have progressed after prior treatment with novel endocrine agents.

-The Overall response rate will be based on the following outcome definitions and a patient will be considered a response if any of these occur:

(1) Objective response (ORR) according to RECIST 1.1 (soft tissue)

Objective response (ORR) according to PCWG-3 (bone) criteria as determined by the local investigator

PSA response will be reported in ng/mL (≥ 50% reduction in PSA from baseline) according to PCWG 3 criteria as determined by the local investigator

Investigator-assessed confirmed radiographic progression-free survival (rPFS) will be reported in weeks per RECIST 1.1 (soft tissue) and PCWG3 (bone)

Investigator-assessed confirmed disease control rate (DCR) per RECIST 1.1 (soft tissue) and PCWG3 (bone)

Investigator-assessed confirmed the time to PSA progression (TTPP) per PCWG3

2. To assess the safety and tolerability of Olaparib in newly diagnosed metastatic castration-resistant prostate cancer with homologous recombination repair gene mutations that have progressed after prior treatment with novel endocrine agent.

-Adverse events/Serious adverse events/AE of special interest

AstraZeneca

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Cytochrome P-450 Enzyme Inhibitors

Subjects will receive a regimen of Olaparib tablets 300 mg twice daily in combination with Abiraterone acetate 1000 mg plus Prednisone 5mg once daily until radiographic disease progression (assessed by the investigator according to RECIST1.1 and PCWG3) or intolerable adverse events (assessed by the investigator according to the actual clinical situation).

Lynparza (Olaparib tablets) 300 mg should be taken orally twice daily.

Olaparib tablet

Qingkeshu (Abiraterone acetate tablets) 1000 mg should be taken orally once daily.

Abiraterone acetate

Prednisone Tablets should be taken 5 mg once daily.

Prednisone tablet

Junlong Zhuang, MD

This is a single-center, single-arm, prospective study to assess the efficacy and safety of Olaparib combined with Abiraterone plus Prednisone in subjects with metastatic hormone sensitive prostate cancer (mHSPC) who carry deleterious germline or homologous recombination repair (HRR) mutations.

Olaparib is an oral, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that potently inhibits the activity of deoxyribonucleic acid repair polymerases. Abiraterone acetate (AA) is a prodrug of abiraterone that potently inhibits cytochrome P450c17, a key enzyme in androgen biosynthesis.

A total of 30 mHSPC subjects with HRR gene mutations that meet the criteria will be included in the study. Eligible subjects will receive oral Olaparib tablets 300 mg BID, combined with Abiraterone acetate 1000 mg QD plus Prednisone 5 mg, and the study will end when the primary endpoint radiographic progression-free survival (rPFS) data maturity reaches 60%. During the treatment and follow-up periods, all subjects will have regular visits to assess the efficacy and safety of Olaparib in combination with abiraterone acetate plus prednisone. Radiographic progression-free survival (rPFS), prostate-specific antigen response (PSA response rate), prostate-specific antigen progression-free survival (PSA-PFS), radiological objective response rate (ORR) and other indicators will be assessed and calculated.

The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation

A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment

Time from the start of study drug to radiographic progression, or death due to any cause, whichever occurs first.

PSA response is defined as a ≥ 50% decline in PSA from baseline PSA value. This PSA decline must be confirmed as sustained by a second PSA value obtained ≥ 3 weeks later.

PSA-PFS is defined as the time from the start of study drug to the first PSA progression or death due to any cause without progression. PSA progression is defined as a first PSA increase greater than or equal to 25% of baseline and ≥ 2 ng/ml and confirmed a second time after 3 or more weeks.

ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = \>=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.

Nanjing Chia-tai Tianqing Pharmaceutical

Hongqian Guo

Director of Urology Department

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Sarcoma

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Urinary Bladder Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Leiomyosarcoma

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Herbal and Botanical

Rucaparib

Cola

Eligible participants will be enrolled in either Cohort A or Cohort B.

Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.

Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.

Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).

Kim Reiss-Binder, MD

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.

Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.

Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.

Measure of clinical benefit, defined as the duration from study enrollment to death.

pharmaand GmbH

Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.

Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

Rucaparib Cohort A

Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Rucaparib Cohort B

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Kim Reiss Binder

Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).

Best Overall Response Rate by Investigator

No data were collected as the independent radiology review was not performed.

Overall Response Rate by Independent Radiology Review

Participants with a deleterious mutation in one of the following genes: BRD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Duration of Response

Disease Control Rate

Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation	NCT05262608	Prostate Cancer Prostate Carcin... Metastatic Cast...	Olaparib	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation	NCT05167175	Prostate Cancer Prostate Carcin... Metastatic Pros...	Olaparib tablet Abiraterone ace... Prednisone tabl...	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes	NCT04171700	Solid Tumor	Rucaparib	18 Years -	pharmaand GmbH
The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation	NCT05167175	Prostate Cancer Prostate Carcin... Metastatic Pros...	Olaparib tablet Abiraterone ace... Prednisone tabl...	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Spots Global Cancer Trial Database for hrr

Every month we try and update this database with for hrr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hrr

Every month we try and update this database with for hrr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hrr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.