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

Not Recruiting

Trial ID: NCT01455493

Purpose

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.

Official Title

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

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor

Eligibility

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

Intervention(s):

drug: GDC-0980

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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