NCT01455493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

October 18, 2011

Last Update Submit

August 9, 2016

Conditions

Endometrial Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

A

EXPERIMENTAL
Drug: GDC-0980

Interventions

GDC-0980DRUG

Oral daily dose

A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Phoenix, Arizona, 85013, United States

Location

Unknown Facility

Newport Beach, California, 92663, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Palo Alto, California, 94305, United States

Location

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Denver, Colorado, 80220, United States

Location

Unknown Facility

New Haven, Connecticut, 06511, United States

Location

Unknown Facility

Boca Raton, Florida, 33487, United States

Location

Unknown Facility

Orlando, Florida, 32804, United States

Location

Unknown Facility

West Palm Beach, Florida, 33401, United States

Location

Unknown Facility

Hinsdale, Illinois, 60521, United States

Location

Unknown Facility

Indianapolis, Indiana, 46237, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Scarborough, Maine, 04074, United States

Location

Unknown Facility

Baltimore, Maryland, 21231, United States

Location

Unknown Facility

Boston, Massachusetts, 02115-6084, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Voorhees Township, New Jersey, 08043, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

New York, New York, 10017, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73104, United States

Location

Unknown Facility

Abington, Pennsylvania, 19001, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Salt Lake City, Utah, 84112, United States

Location

Unknown Facility

Seattle, Washington, 98195, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 20, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

January 1, 2014

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

US(28)