Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: February 4, 2015
Last verified: February 2015

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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Nature of adverse events [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Severity of adverse events [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: December 2011
Study Completion Date: February 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
Genders 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

  Show 28 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc. Identifier: NCT01455493     History of Changes
Other Study ID Numbers: PIM4972g
Study First Received: October 18, 2011
Last Updated: February 4, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms processed this record on February 27, 2015