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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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01442090
Collaborator
(none)
85
Enrollment
22
Locations
2
Arms
45
Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax) of GDC-0980 [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 [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 [pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1]

  4. Cmin of everolimus [pre-dose on Week 1 Day 1 and Week 9 Day 1]

  5. Number of participants with adverse events [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 [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 [Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)]

  8. Duration of overall survival (OS) [Baseline until death (up to approximately 45 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Fort Myers Florida United States 33908
2 Saint Petersburg Florida United States 33705
3 Boston Massachusetts United States 02215
4 Las Vegas Nevada United States 89148
5 New York New York United States 10065
6 Durham North Carolina United States 27710
7 Cleveland Ohio United States 44195
8 Nashville Tennessee United States 37203
9 Bordeaux France 33075
10 Paris France 75908
11 Villejuif France 94800
12 Berlin Germany 10117
13 Hannover Germany 30625
14 München Germany 81377
15 Barcelona Spain 08003
16 Barcelona Spain 08035
17 Madrid Spain 28041
18 Leeds United Kingdom LS9 7TF
19 London United Kingdom EC1A 7BE
20 London United Kingdom SW3 6JJ
21 Manchester United Kingdom M20 4BX
22 Sutton United Kingdom SM2 5PT

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01442090
Other Study ID Numbers:
  • PIM4973g
  • GO00885
  • 2011-000493-56
First Posted:
Sep 28, 2011
Last Update Posted:
Aug 10, 2016
Last Verified:
May 1, 2016
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Everolimus

Study Results

No Results Posted as of Aug 10, 2016