Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT03924245
Phase
PHASE1
Status
Terminated

Conditions

  • Fallopian Tube Cancer
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Recurrent Endometrial Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Entinostat — DRUG
    Given by mouth
  • Olaparib — DRUG
    Given by mouth

Study Details

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.

Key Dates

Start date
Oct 1, 2020
Status verified
Mar 2022
Primary completion
Feb 4, 2022
Completion
Feb 4, 2022

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (entinostat, olaparib)
    Patients receive entinostat PO 1 week before starting combination therapy (day -7). Patients then receive entinostat PO on days 1, 8, 15, and 22, olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression and unacceptable toxicity

Primary Outcome Measure

Maximum tolerated dose (phase I) [ Time Frame: 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Kansas City, KS

By research site
University of Kansas Cancer Center· Kansas City, KSVanderbilt-Ingram Cancer Center· Nashville, TN

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