Study of GDC-0980 Versus Everolimus in Participants With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following Vascular Endothelial Growth Factor- (VEGF) Targeted Therapy

August 8, 2016 updated by: Genentech, Inc.

A Phase II, Open-Label, Randomized Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy

Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
      • Paris, France, 75908
      • Villejuif, France, 94800
  • Germany
      • Berlin, Germany, 10117
      • Hannover, Germany, 30625
      • München, Germany, 81377
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
      • London, United Kingdom, SW3 6JJ
      • London, United Kingdom, EC1A 7BE
      • Manchester, United Kingdom, M20 4BX
      • Sutton, United Kingdom, SM2 5PT
  • United States
    • Florida
      • Fort Myers, Florida, United States, 33908
      • Saint Petersburg, Florida, United States, 33705
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Nevada
      • Las Vegas, Nevada, United States, 89148
    • New York
      • New York, New York, United States, 10065
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Tennessee
      • Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically documented, incurable metastatic renal cell carcinoma with clear-cell component that progressed on or within 6 months of stopping VEGF-targeted therapy
  • Disease that is measurable per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
  • Karnofsky performance status of greater than or equal to (>=) 70 percent (%)
  • Adequate hematologic and end organ function
  • For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use two effective forms of contraception and to continue its use for the duration of the study

Exclusion Criteria:

  • Any anti-cancer therapy, including chemotherapy, biologic or other targeted therapy, herbal therapy, hormonal therapy, or radiotherapy, within 5 half-lives (for systemic agents) or 2 weeks, whichever is shorter, prior to Day 1. Certain forms of radiation therapy may be considered for pain palliation if participants are deriving benefit
  • Previously established diagnosis of pulmonary fibrosis of any cause
  • New York Heart Association (NYHA) Class II or greater congestive heart failure
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Presence of positive test results for hepatitis B (hepatitis B [HB] surface antigen [HBsAg] and/or total HB core antibody [anti-HB-c; both tests are required]) or hepatitis C
  • Known human immunodeficiency virus (HIV) infection
  • Pregnancy, lactation, or breastfeeding
  • 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
  • Leptomeningeal disease as a manifestation of cancer
  • History of other malignancies less than equal to <= 5 years of Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Need for current chronic corticosteroid therapy (>= 10 milligrams [mg] of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids for greater than [>] 7 days) or use of other immunosuppressant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Everolimus
Participants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Drug: Everolimus
Everolimus will be administered orally at a 10 mg daily dose.
Experimental: GDC-0980
Participants will receive GDC-0980 (40 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Drug: GDC-0980
GDC-0980 will be administered orally at a 40 mg daily dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1
Time Frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration (Cmax) of GDC-0980
Time Frame: pre-dose and 1, 2, 4 hours post-dose on Week 1 Day 1, Pre-dose on Week 1 Day 2, pre-dose and 2 hours post dose on Week 3 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)
pre-dose and 1, 2, 4 hours post-dose on Week 1 Day 1, Pre-dose on Week 1 Day 2, pre-dose and 2 hours post dose on Week 3 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)
Cmax of everolimus
Time Frame: pre-dose and 2, hours post-dose on Week 1 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)\n
pre-dose and 2, hours post-dose on Week 1 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)\n
Minimum plasma concentration (Cmin) of GDC-0980
Time Frame: pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1
pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1
Cmin of everolimus
Time Frame: pre-dose on Week 1 Day 1 and Week 9 Day 1
pre-dose on Week 1 Day 1 and Week 9 Day 1
Number of participants with adverse events
Time Frame: up to 30 days after end of treatment (approximately up to 23 months)
up to 30 days after end of treatment (approximately up to 23 months)
Number of participants with objective tumor response as assessed by the investigator using RECIST v1.1
Time Frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Duration of objective tumour response as assessed by the investigator using RECIST v1.1
Time Frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Duration of overall survival (OS)
Time Frame: Baseline until death (up to approximately 45 months)
Baseline until death (up to approximately 45 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIM4973g
  • GO00885 (Other Identifier: Hoffmann-La Roche)
  • 2011-000493-56 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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