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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01455493
First received: October 18, 2011
Last updated: July 21, 2014
Last verified: July 2014

October 18, 2011
July 21, 2014
December 2011
March 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01455493 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma

This is a multicenter, single-arm, open-label Phase II study to evaluate the act ivity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluate d.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Carcinoma
Drug: GDC-0980
Oral daily dose
Experimental: A
Intervention: Drug: GDC-0980
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
February 2014
March 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01455493
PIM4972g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP