Abramson Cancer Center at Penn Medicine
The main purpose of this study is to study the effect of saruparib, an experimental PARP inhibitor, on tumors that have an Homologous Recombination Deficiency Signature (HRDsig) positive tumor by the investigational FoundationOne®CDx clinical trial assay.
This is an open-label, phase II study of saruparib in patients with locally advanced or metastatic solid tumors that are HRDsig+ by FoundationOneCDx (Foundation Medicine, Inc). Patients in Cohort A must also have a pathogenic germline or somatic variant in BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D or BARD1. The primary endpoint is overall response rate in Cohort A.
Inclusion Criteria: * Eastern Cooperative Oncology (ECOG) performance status of 0 to 1 * Diagnosis of a metastatic or locally advanced solid tumor malignancy for which no cure is considered possible. 1. Patients with breast, ovarian, prostate or pancreatic cancer may not enroll within Cohort A 2. Patients with ovarian cancer may not enroll in Cohort B * No history of resistance to platinum therapy, defined as disease progression within six months of exposure to platinum chemotherapy (ie cisplatin, oxaliplatin, carboplatin). Patients may be platinum-naïve at time of enrollment. * Progress…
Saruparib (AZD5305) 60mg PO daily
Tumors will be tested for positive HRDsig tumor by the investigational FoundationOne®CDx clinical trial assay.
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