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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: October 18, 2011
Last updated: August 9, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Endometrial Carcinoma Drug: GDC-0980 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Objective tumor response as assessed by the investigator using RECIST v1.1 [ Time Frame: 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 [ Time Frame: at 6 months ]

Secondary Outcome Measures:
  • Overall survival (OS), defined as the time from treatment initiation until death from any cause [ Time Frame: 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 [ Time Frame: up to approximately 23 months ]
  • Incidence of adverse events [ Time Frame: up to approximately 23 months ]
  • Nature of adverse events [ Time Frame: up to approximately 23 months ]
  • Severity of adverse events [ Time Frame: up to approximately 23 months ]

Enrollment: 56
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0980
Oral daily dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01455493

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

Responsible Party: Genentech, Inc. Identifier: NCT01455493     History of Changes
Other Study ID Numbers: PIM4972g
Study First Received: October 18, 2011
Last Updated: August 9, 2016

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female processed this record on September 21, 2017