A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

Phase 2

Completed

• Conditions: Ovarian Epithelial Carcinoma
• Interventions: Drug: PD0332991

• Registration Number: NCT01536743
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-01
• Study Start: 2011-12-15
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-24
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD0332991	PD0332991	30 patients with recurrent ovarian epithelial carcinoma demonstrating Rb-proficiency and absent or low expression of p16 will be registered to receive PD0332991 once a day by mouth in the morning on an empty stomach. PD0332991 will be administered daily for 3 weeks followed by 1 week off treatment (28 day cycle).

Primary Outcome Measures

Name	Time	Method
Estimate biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma.	4 weeks	CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).

Secondary Outcome Measures

Name	Time	Method
Assess health-related quality of life (HRQL),	4 weeks
Toxicity of PD0332991.	4 weeks	Toxicity of PD0332991 will be graded using the NCI Common Toxicity Criteria, version 3.0

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States