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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01442090
First received: September 26, 2011
Last updated: August 8, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Renal Cell Carcinoma
Drug: Everolimus
Drug: GDC-0980
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cmin of everolimus [ Time Frame: pre-dose on Week 1 Day 1 and Week 9 Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to 30 days after end of treatment (approximately up to 23 months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Duration of overall survival (OS) [ Time Frame: Baseline until death (up to approximately 45 months) ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: October 2011
Study Completion Date: July 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442090

Locations
United States, Florida
Fort Myers, Florida, United States, 33908
Saint Petersburg, Florida, United States, 33705
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New York
New York, New York, United States, 10065
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Tennessee
Nashville, Tennessee, United States, 37203
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, EC1A 7BE
London, United Kingdom, SW3 6JJ
Manchester, United Kingdom, M20 4BX
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01442090     History of Changes
Other Study ID Numbers: PIM4973g  GO00885  2011-000493-56 
Study First Received: September 26, 2011
Last Updated: August 8, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Endothelial Growth Factors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Growth Substances

ClinicalTrials.gov processed this record on September 29, 2016