Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Prima… (NCT03924245) | Clinical Trial Compass
TerminatedPhase 1
Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers
Stopped: Change in participant landscape and other treatment availability
United States3 participantsStarted 2020-10-01
Plain-language summary
This phase I/II trial studies the side effects and best dose of olaparib and entinostat and to see how well they work in treating patients with ovarian, primary peritoneal, or fallopian tube cancers that have come back or do not respond to platinum-based chemotherapy. Olaparib and entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* High-grade carciomas of the ovary, fallopian tube, or periteonum, based on local pathology review, including high grade serous carcinoma, high grade endometrioid carcinomas, clear cell carcinoma, and carcinosarcoma.
* Platinum-refractory or resistant disease, as defined by progressive disease while receiving platinum-based chemotherapy or with recurrent disease \< 6 months after the completion of platinum-based chemotherapy.
* May have received up to 2 prior therapies for platinum-resistant ovarian cancer.
* Must have received prior-platinum-based chemotherapy.
* BRCA1, BRCA2, RAD51, BRIP1, ATM, FANCL, PALB2 and other FA/BRCA pathway gene wild-type.
* Tumor HR-proficient, as assessed by Myriad myChoice HRD Test (HRD score \< 42).
* Provision of informed consent prior to any study specific procedures
* Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
* Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
* Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L
* Platelet count ≥ 100 x 109 /L
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
* Patient…