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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


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
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