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Completed

NCT Number: NCT01442090

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

Everolimus will be administered orally at a 10 mg daily dose.

GDC-0980

Drug

GDC-0980 will be administered orally at a 40 mg daily dose.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Cmin of everolimus

    Time frame: pre-dose on Week 1 Day 1 and Week 9 Day 1

  5. Number of participants with adverse events

    Time frame: up to 30 days after end of treatment (approximately up to 23 months)

  6. 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)

  7. 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)

  8. Duration of overall survival (OS)

    Time frame: Baseline until death (up to approximately 45 months)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Sep 28, 2011
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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