Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT04469764|
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Endometrial Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Abemaciclib Drug: Anastrozole Drug: Letrozole||Phase 2|
I. To obtain an estimate of the proportion of patients' progression-free at 16 weeks (16 week progression free survival [PFS] rate) in patients with recurrent ovarian (including fallopian tube and primary peritoneal) or recurrent endometrial cancer following treatment with abemaciclib as a molecularly matched targeted therapy.
I. To assess objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST), progression free survival (PFS) and safety following treatment with abemaciclib as a molecularly matched targeted therapy.
I. To explore the relationship between response to abemaciclib and somatic gene alterations that lead to CDK4/6 activation in ovarian cancer.
II. To explore the relationship between response to abemaciclib and hormone receptor expression levels as well as somatic gene alterations that lead to CDK4/6 activation in endometrial cancer.
Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Patients with tumors that are hormone receptor positive also receive anastrozole or letrozole per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days, and then every 12 weeks up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase II Study of the Efficacy and Safety of Abemaciclib, a Cyclin Dependent Kinase (CDK4/6) Inhibitor in Selected Patients With Recurrent Ovarian or Endometrial Cancer|
|Actual Study Start Date :||October 16, 2020|
|Estimated Primary Completion Date :||July 1, 2024|
|Estimated Study Completion Date :||July 1, 2025|
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.
- Proportion of patients who are progression-free [ Time Frame: At 16 weeks ]Will be calculated with corresponding 95% unadjusted exact binomial confidence interval (CI).
- Objective response rate (ORR) [ Time Frame: Up to 1 year ]Assessed per Response Evaluation Criteria in Solid Tumors (RECIST).
- Progression free survival (PFS) [ Time Frame: Time from registration until date of progression or death, assessed up to 1 year ]Date of progression will be defined as the date of the first imaging or clinical exam or biochemical occurrence showing disease progression. PFS will be calculated with corresponding 95% unadjusted exact binomial confidence interval. Kaplan-Meier estimates and Kaplan Meier plots of this endpoint will be produced. Two-sided 95% confidence intervals will accompany the Kaplan-Meier estimate of the median.
- Incidence of adverse events [ Time Frame: At 16 weeks and up to 90 days after completion of treatment ]To assess safety
- Clinical benefit rate [ Time Frame: Up to 1 year after completion of treatment ]Defined as achieving a confirmed objective response (complete response [CR] or partial response [PR]) or achieving stable disease for a minimum duration of 4 months, will be provided with the exact two-sided 95% confidence interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469764
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Kim Kelly 310-206-8309 firstname.lastname@example.org|
|Principal Investigator: Gottfried E. Konecny|
|Principal Investigator:||Gottfried E Konecny||UCLA / Jonsson Comprehensive Cancer Center|