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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442090
• Other study ID #: PIM4973g
• Secondary ID: GO008852011-0004
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2011
• Last updated: August 8, 2016
• Start date: October 2011
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Everolimus
Everolimus will be administered orally at a 10 mg daily dose.
• GDC-0980
GDC-0980 will be administered orally at a 40 mg daily dose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	Cmin of everolimus		pre-dose on Week 1 Day 1 and Week 9 Day 1	No
Secondary	Number of participants with adverse events		up to 30 days after end of treatment (approximately up to 23 months)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Duration of overall survival (OS)		Baseline until death (up to approximately 45 months)	No