A Phase 2 trial of Nirogacestat in Patients with Recurrent Ovarian Granulosa Cell Tumors

SpringWorks Therapeutics, Inc.0 个研究点目标入组 43 人2022年10月11日

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注册库

who.int

开始日期

2022年10月11日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

Female

发起方

•1\. Participant must be aged \= 18 years of age inclusive
•2\. Participant has histologically confirmed recurrent adult\-type granulosa cell tumor of the ovary prior to first dose of study treatment and agrees to provide archival or new tumor tissue.
•3\. Participant must have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by RECIST v1\.1 criteria. Prior systemic therapy is not limited to therapy type nor is any specific prior line of therapy required.
•4\. Participant must have a ECOG performance Grade of 0, 1, or 2 at Screening.
•5\. Participant must have adequate bone marrow, renal and hepatic function as defined by the following Screening laboratory values:
•a. Absolute neutrophil count (ANC) \=1,000 cells/µL;
•b. Platelets \= 75,000/µL;
•c. Estimated glomerular filtration rate (eGFR) \= 60 mL/min/1\.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD\-EPI) equation (Grade \= 1\).
•d. Total bilirubin \= 1\.5 ×ULN (isolated bilirubin \> 1\.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%);
•e. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine

•1\. Participant has any of the following:
•Signs of bowel obstruction who require parenteral nutrition.
•Malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat (e.g., gastric bypass, lap band, or other gastric procedures that would alter absorption).
•Participant has experienced any of the following within 6 months of signing informed consent:
•Clinically significant cardiac disease (New York Heart Association Class III or IV);
•Myocardial infarction;
•Severe/unstable angina;
•Coronary/peripheral artery bypass graft;
•Symptomatic congestive heart failure;
•Cerebrovascular accident;