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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Endometrial Carcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

up to approximately 23 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

PIM4972g

NCT ID:

NCT01455493

Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Endometrial Carcinoma
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Seattle, Washington  98195
Louisville, Kentucky  40207
Scarborough, Maine  04074
Hackensack, New Jersey  07601
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Tulsa, Oklahoma  
Salt Lake City, Utah  84112