A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Carcinoma
• Intervention / Treatment: Drug: GDC-0980

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
  • California
    • Newport Beach, California, United States, 92663
    • Orange, California, United States, 92868
    • Palo Alto, California, United States, 94305
    • San Francisco, California, United States, 94115
  • Colorado
    • Denver, Colorado, United States, 80220
  • Connecticut
    • New Haven, Connecticut, United States, 06511
  • Florida
    • Boca Raton, Florida, United States, 33487
    • Orlando, Florida, United States, 32804
    • West Palm Beach, Florida, United States, 33401
  • Illinois
    • Hinsdale, Illinois, United States, 60521
  • Indiana
    • Indianapolis, Indiana, United States, 46237
  • Kentucky
    • Louisville, Kentucky, United States, 40202
  • Maine
    • Scarborough, Maine, United States, 04074
  • Maryland
    • Baltimore, Maryland, United States, 21231
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
    • Boston, Massachusetts, United States, 02115-6084
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
  • New York
    • New York, New York, United States, 10016
    • New York, New York, United States, 10017
  • North Carolina
    • Durham, North Carolina, United States, 27710
    • Winston-salem, North Carolina, United States, 27103
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
    • Pittsburgh, Pennsylvania, United States, 15213
  • Utah
    • Salt Lake City, Utah, United States, 84112
  • Washington
    • Seattle, Washington, United States, 98195
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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
• Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory drugs
• Need for current chronic corticosteroid therapy
• Pregnancy, lactation, or breastfeeding
• Current severe, uncontrolled systemic disease
• Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment
• Uncontrolled hypercalcemia
• Leptomeningeal disease as a manifestation of cancer
• Known untreated or active brain metastases
• Grade >=2 hypercholesterolemia or hypertriglyceridemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: GDC-0980; Oral daily dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective tumor response as assessed by the investigator using RECIST v1.1	up to approximately 23 months
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	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Incidence of adverse events	up to approximately 23 months
Nature of adverse events	up to approximately 23 months
Severity of adverse events	up to approximately 23 months

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Carcinoma; Endometrial Neoplasms
• Other Study ID Numbers: PIM4972g