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

Endometrial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455493
• Other study ID #: PIM4972g
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2011
• Last updated: August 9, 2016
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: August 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms

Intervention

Drug:
• GDC-0980
Oral daily dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response as assessed by the investigator using RECIST v1.1		up to approximately 23 months	No
Primary	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	No
Secondary	Overall survival (OS), defined as the time from treatment initiation until death from any cause		up to approximately 36 months	No
Secondary	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	No
Secondary	Incidence of adverse events		up to approximately 23 months	No
Secondary	Nature of adverse events		up to approximately 23 months	No
Secondary	Severity of adverse events		up to approximately 23 months	No