A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma

Genentech, Inc.0 sites56 target enrollmentDecember 2011

ConditionsEndometrial Carcinoma

InterventionsGDC-0980

DrugsGDC-0980

Overview

Phase: Phase 2
Intervention: GDC-0980
Conditions: Endometrial Carcinoma
Sponsor: Genentech, Inc.
Enrollment: 56
Primary Endpoint: Progression-free survival (PFS), defined as the time from the first GDC-0980 treatment to disease progression as assessed by the investigator using RECIST v1.1, or death from any cause while on study
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

January 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments
•Histologic confirmation of the original primary tumor is required
•Histologic or cytologic confirmation of the recurrent/progressive disease is desired
•Patients must have had at least one but no more than two prior chemotherapeutic regimens for management of endometrial carcinoma
•Disease that is measurable per RECIST v1.1
•No active infection requiring antibiotics
•Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to first study treatment
•Any other prior therapy directed at the malignant tumor, including immunologic agents and radiotherapy, must be discontinued at least 2 weeks prior to first study treatment
•Adequate hematologic and end organ function

Exclusion Criteria

•Type I diabetes or Type II diabetes requiring insulin
•Prior use of mTOR/PI3K inhibitor
•Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
•Previous diagnosis of pulmonary fibrosis of any cause
•History of myocardial infarction or unstable angina within 6 months prior to first study treatment
•Congestive heart failure
•History of malabsorption syndrome or other condition that would interfere with enteral absorption
•Clinically significant history of liver disease, including cirrhosis and current alcohol abuse
•Presence of positive test results for hepatitis B or hepatitis C
•Known HIV infection

Arms & Interventions

A

Intervention: GDC-0980

Outcomes

Primary Outcomes

Progression-free survival (PFS), defined as the time from the first GDC-0980 treatment to disease progression as assessed by the investigator using RECIST v1.1, or death from any cause while on study

Time Frame: at 6 months

Objective tumor response as assessed by the investigator using RECIST v1.1

Time Frame: up to approximately 23 months

Secondary Outcomes

Incidence of adverse events(up to approximately 23 months)
Nature of adverse events(up to approximately 23 months)
Overall survival (OS), defined as the time from treatment initiation until death from any cause(up to approximately 36 months)
Duration of objective tumor response defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1(up to approximately 23 months)
Severity of adverse events(up to approximately 23 months)