Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04469764
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Endometrial Carcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma

Eligibility Criteria

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

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Anastrozole — DRUG
    Given PO
  • Letrozole — DRUG
    Given PO

Study Details

This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib may work better for the treatment of recurrent ovarian and endometrial cancer.

Key Dates

Start date
Oct 16, 2020
Status verified
Jun 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (abemaciclib)
    Patients receive abemaciclib PO BID on days 1-28. Patients with tumors that are hormone receptor positive also receive and anastrozole or letrozole per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of patients who are progression-free [ Time Frame: At 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Kim Kelly
[email protected]
310-206-8309
Gottfried E. Konecny (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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