“These preliminary results suggest that PARP inhibition with niraparib may play an important role in the treatment of men with metastatic castration-resistant prostate cancer who have mutations in DNA-repair genes,” said GALAHAD is an ongoing open-label Phase 2 study assessing niraparib in patients with DRD who had progressed after treatment with next-generation androgen-receptor signaling therapies (ARSIs) and docetaxel.The most common Grade 3/4 adverse events (AEs) were primarily hematologic, which included anemia (26 percent), thrombocytopenia (15 percent), neutropenia (8 percent) and leukopenia (6 percent).“It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15 percent and a median progression-free survival of three months with currently available therapies,” said We are Janssen.
Please see our Galahad is a phase 2 clinical trial that will enroll approximately 215 participants. The GALAHAD study (NCT02854436), sponsored by Janssen, is testing 300 mg daily Zejula in patients whose disease worsened after treatment with next-generation androgen-receptor signaling therapies — a mainstay in the treatment of prostate cancer — and the chemotherapy docetaxel. The MAGNITUDE study is a phase III look into the use of the drug with abiraterone acetate (Zytiga) and prednisone versus just abiraterone acetate and prednisone for the treatment of …
Janssen Research & Development, LLC: ClinicalTrials.gov Identifier: NCT03748641 Other Study ID Numbers: CR108534 2017-003364-12 ( EudraCT Number ) 64091742PCR3001 ( Other Identifier: Janssen Research & Development, LLC ) First Posted: November 21, 2018 Key Record Dates: Last Update Posted: August 21, 2020 All contents © Copyright Johnson & Johnson Services, Inc.1997-2020. "It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15 percent and a median progression-free survival of three months with currently available therapies," said We are Janssen. Abstract #202. Learn more at SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson© 1985 - 2020 BioSpace.com. UPDATE: Tesaro Says Janssen Anticipates Re-opening Enrollment for Galahad Trial Soon -8-K This includes investigational medication, … "The GALAHAD study (NCT02854436), sponsored by Janssen, is testing 300 mg daily Zejula in patients whose disease worsened after treatment with next-generation androgen-receptor signaling therapies — a mainstay in the treatment of prostate cancer — and the chemotherapy docetaxel. Phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): preliminary results of GALAHAD. “Given these results, prospective biomarker testing could enable healthcare professionals to personalize therapy for patients with metastatic castration-resistant prostate cancer in the future.”This site is governed solely by applicable U.S. laws and governmental regulations. We collaborate with the world for the health of everyone in it. Janssen Research & Development, Los Angeles, U 11. Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects (DRD)Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects (DRD) Erdafitinib is a small molecule inhibitor of fibroblast growth factor receptor (FGFR) approved for treatment of cancer and marketed under the name Balversa.FGFRs are a subset of tyrosine kinases which are unregulated in some tumors and influence tumor cell differentiation, proliferation, angiogenesis, and cell survival.
Phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): preliminary results of GALAHAD.
All Rights Reserved. Please click below to continue to that site. San Francisco, February 14, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson will present today at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) early results from the ongoing Phase 2 GALAHAD study evaluating niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) … Possible patient benefits: Eligible participants may receive all study‐required care at no charge. Learn more at SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson RARITAN, N.J.,October 3, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer … "It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15 percent and a median progression-free survival of three months with currently available therapies," said We are Janssen. “Additional therapies are needed to address unmet medical needs in metastatic castration-resistant prostate cancer and we look forward to accumulating more evidence about the role of niraparib in this important setting. Powered by Madgex Job Board Software How We’re Mobilizing Our Resources to Help Find Solutions for COVID-19 We collaborate with the world for the health of everyone in it. Learn more at SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson© 1985 - 2020 BioSpace.com. GALAHAD is an ongoing open-label Phase II study assessing niraparib (300 mg daily) in patients with mCRPC and DNA repair defects with disease progression on taxane and androgen receptor-targeted therapy.