^
Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Lynparza (olaparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers
Excerpt:
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers….The three approvals authorise Lynparza for:...maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.
Source:
Title:
A study, performed in several centers, to examine the treatment of Olaparib at the time of disease progression in ovarian, peritoneal or fallopian tube cancer before an operation.
Excerpt:
...• Biological effects in the primary tumour following a short pre-operative course of treatment with Olaparib in patients with platinum sensitive relapsed ovarian cancer; the biological effects are assess in terms of the degree of PAR or PARP-1 inhibition (in tissue and ctDNA) • Germline HRD mutations and tissue mutation with respect to BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 (in tissue and ctDNA)• Generate initial clinical efficacy data for future studies (RECIST 1.1)...
Trial ID:
Source:
Title:
an open explorative phase II, open label study of olaparib in the treatment of advanced cancer in patients carrying a somatic or germline mutation in a homologous recombination gene.
Excerpt:
...1- Provision of informed consent prior to any study specific procedures 2- Female or male aged > 18 years 3- Histologically proven advanced cancer, either locally or metastatic, harboring a specific pathogenic genetic alteration (with the exception of breast, pancreas, ovarian or prostate cancer patients harboring a BRCA1/2 mutation) 4- No approved targeted therapy for the specific genetic alteration in the specific tumor type 5- No other genomic driven phase I, II or III trial available for the specific genomic alteration in the specific tumor type 6- Available tumor tissue for verification of the mutation by Sanger sequencing. ...
Trial ID:
More C2 evidence
Source:
Title:
Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations
Excerpt:
...Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue....
Trial ID:
Source:
Title:
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Excerpt:
...- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Trial ID:
Source:
Title:
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.
Excerpt:
...- Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious....
Trial ID:
Source:
Title:
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)
Excerpt:
...Time from randomisation to second progression or clinical progression or death, whichever occurs earlier`To assess progression in pain severity domain, change in pain interference domain, and pain palliation`Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P) total score, Functional Assessment of Cancer Therapy- General (FACT-G) total score, trial outcome index, functional well-being, physical well-being, prostate cancer subscale, and Functional Assessment of Cancer Therapy (FACT) Advanced Prostate Symptom Index-6 (FAPSI-6)`Tumour samples for mutations in Breast Cancer 1 gene (BRCA1), or Breast Cancer 2 gene (BRCA2), Ataxia-telangiectasia mutated (ATM) and 12 other Homologous Recombination Repair (HRR) genes will be evaluated.`...
Trial ID:
Source:
Title:
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
Excerpt:
...Time from randomisation to second progression or clinical progression or death`To assess progression in pain severity domain, change in pain interference domain, and pain palliation`Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P) total score, Functional Assessment of Cancer Therapy- General (FACT-G) total score, trial outcome index, functional well-being, physical well-being, prostate cancer subscale, and Functional Assessment of Cancer Therapy (FACT) Advanced Prostate Symptom Index-6 (FAPSI-6)`Tumour and blood samples for mutations in Breast Cancer 1 gene (BRCA1), or Breast Cancer 2 gene (BRCA2), Ataxia-telangiectasia mutated (ATM) and 12 other Homologous Recombination Repair (HRR) genes will be evaluated.`...
Trial ID:
Source:
Title:
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Excerpt:
...- Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Trial ID:
Source:
Title:
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
Excerpt:
...For enrichment stage of trial only (if necessary): Confirmation of a suspected/known deleterious mutation in a gene of interest (ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or other DNA repair genes) via CLIA certified testing....
Trial ID:
Source:
Title:
Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors
Excerpt:
...- All participants must have documented BRCA 1/2 mutant or other HRD+ in solid tumor, which is identified through a validated sequencing test...
Trial ID:
Source:
Title:
Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2
Excerpt:
...- Participants must have a germline or somatic DNA damage repair mutation or deletion in BRCA1 or BRCA2....
Trial ID:
Source:
Title:
C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
Excerpt:
...- Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))...
Trial ID:
Source:
Title:
Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
Excerpt:
...somatic mutations in ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A] or germline mutations in the above genes....
Trial ID:
Source:
Title:
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Excerpt:
...- Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious...
Trial ID:
Source:
Title:
Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.
Excerpt:
......
Trial ID:
Source:
Title:
MITO 35a: Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wild-type Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer
Excerpt:
...Documented absence of somatic and germline mutations of BRCA 1 /2....
Trial ID:
Source:
Title:
Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study
Excerpt:
...Documented absence of somatic and germline mutations of BRCA1 or BRCA2 genes, that is predicted to be deleterious or suspected deleterious 4....
Trial ID:
Source:
Title:
Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients
Excerpt:
...- Documented gBRCA1/2 mutation status...
Trial ID:
Source:
Title:
Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab
Excerpt:
...Progression-free survival (PFS) and Overall survival (OS) will be evaluated according to biomarkers ((i.e., PD-L1, ERCC1, SLFN11, STK11, KEAP1, p53 expression, DNA repair genes [including BRCA 1-2 mutations] and tumor mutational burden)....
Trial ID:
Source:
Title:
To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer
Excerpt:
...Documented germline or somatic mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) [Genetic counselling for patients with germline BRCA mutations should be performed according to local regulations] Or Tumour BRCAwt status and documented qualifying mutation in any of 13 genes involved in the HRR pathway, excluding BRCA1 and BRCA2 (ATM, BARD1, BRIP1,CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D,and RAD54L), identified by the Lynparza HRR Assay in archival tumour tissue (i.e.,BRCA-independent HRRm) 4....
Trial ID:
Source:
Title:
Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer
Excerpt:
...Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation....
Trial ID:
Source:
Title:
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
Excerpt:
...Patients are eligible to undergo BRCA testing even if they have - Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) - At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment. ...
Trial ID:
Source:
Title:
Functional Analysis of BRCAness
Excerpt:
...time from start of maintenance olaparib to the date of first documented disease progression or death from any cause, whichever occurs first, of olaparib for the BRCA1 or BRCA2 mutant (germline or somatic) HR deficient group, the non BRCA mutant HR deficient group and the HR proficient group`time from start olaparib to death (any cause).`...
Trial ID:
Source:
Title:
Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations
Excerpt:
...1) BRCA1 or BRCA2 mutation, ATM deficiency, MRE11A mutation 2) Mutation of other HR(homologous recombination) pathway genes: BLM, NBN, RAD50, RAD52, RAD54L, RAD51, RAD51B, RAD51C, RAD51D, RECQL, RECQL4, RECQL5, RPA1, WRN etc....
Trial ID:
Source:
Title:
NUVOLA TRIAL Open-label Multicentre Study
Excerpt:
...Documented mutation in BRCA1 or BRCA2 germline and/or somatic that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function); 4....
Trial ID:
Source:
Title:
Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers
Excerpt:
...Men with BRCA1/2 mutation and metastatic breast cancer will be eligible for study....
Trial ID:
Source:
Title:
AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer
Excerpt:
...For patients enrolling in the sporadic serous epithelial ovarian cancer group, Group B, a negative family history (BRCAPRO score less than or equal to 20% or negative BRCA1/2 mutation test)....
Trial ID:
Source:
Title:
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
Excerpt:
...- Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious...
Trial ID:
Source:
Title:
Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan
Excerpt:
...Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious from germline or a tumour specimen, prior to provision of informed consent 5....
Trial ID:
Source:
Title:
Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients
Excerpt:
...Mutation of BRCA 1 and/or 2 for ARM B only...
Trial ID:
Source:
Title:
nd nd
Excerpt:
...Documented mutation in BRCA1 or BRCA2 germline and/or somatic that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function);4. ...
Trial ID:
Source:
Title:
ANZ 1103 Study of Olaparib Clinical Effect in Patients with Breast Cancer or Ovarian Cancer
Excerpt:
......
Trial ID:
Source:
Title:
Predicting olaparib sensitivity in metastatic HER2-negative breast cancer with BRCA1, BRCA2, PALB2, RAD51C or RAD51D mutation or RAD51-negative test Predicción de la sensibilidad a Olaparib en pacientes con cáncer de mama HER2 negativo localmente avanzado irresecable o metastásico con mutaciones en BRCA1, BRCA2, PALB2, RAD51C o RAD51D o con niveles bajos RAD51
Excerpt:
...Los pacientes deben ser hombres o mujeres de ≥18 años 3.Los pacientes deben de tener la capacidad de proporcionar un formulario de consentimiento informado por escrito firmado y fechado antes de cualquier procedimiento, muestreo y análisis.4.Cáncer de mama confirmado histológica o citológicamente con evidencia de enfermedad localmente avanzada5.Los pacientes pueden tener cáncer de mama triple negativo y HER2 negativo o cáncer de mama ER / PgR positivo, siempre que sean HER2 negativo y coherentes con los estándares locales y las pautas más recientes de ASCO CAP Cohorte 1: Mutación en BRCA1, BRCA2, PALB2, RAD51C o RAD51D 6.Pacientes que hayan recibido platino y no haya habido evidencia de progresión de la enfermedad durante la quimioterapia.7.Pacientes que hayan recibido platino y / o inhibidores de PARP y que hayan transcurrido al menos 6 meses entre la última dosis de PARP. ...
Trial ID:
Less C2 evidence
Source:
Title:
98P - Olaparib (O) in patients (pts) with solid tumors with BRCA1/2 mutation (mut): Results from the targeted agent and profiling utilization registry (TAPUR) study
Published date:
09/05/2022
Excerpt:
32 pts with solid tumors with BRCA1 (N=13) or BRCA2 (N=19) mut were enrolled from July 2016 to December 2018. All pts were evaluable for efficacy and toxicity. The table shows demographics and outcomes. 2 CR (1 BRCA1, stomach cancer; 1 BRCA2, unknown primary), 6 PR (2 BRCA1; 4 BRCA2; all had unique primary tumors) and 5 SD16+ (1 BRCA1; 4 BRCA2; 2/5 pts colorectal cancer, 3/5 had unique primary tumors) were observed for DC rate of 41% (90% CI, 29% to 100%) and OR rate of 25% (95% CI, 11% to 43%). The null DC rate was rejected. 12 pts had ≥1 Grade 3/4 adverse or serious adverse event at least possibly related to O. O monotherapy demonstrated evidence of anti-tumor activity in pts with various solid tumors with BRCA1/2 mut.
Trial ID: