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
NCT ID: NCT01442090
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2011-10-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Everolimus
Participants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Everolimus
Everolimus will be administered orally at a 10 mg daily dose.
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.
GDC-0980
GDC-0980 will be administered orally at a 40 mg daily dose.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Fort Myers, Florida, United States
St. Petersburg, Florida, United States
Boston, Massachusetts, United States
Las Vegas, Nevada, United States
New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Bordeaux, , France
Paris, , France
Villejuif, , France
Berlin, , Germany
Hanover, , Germany
München, , Germany
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Leeds, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Powles T, Lackner MR, Oudard S, Escudier B, Ralph C, Brown JE, Hawkins RE, Castellano D, Rini BI, Staehler MD, Ravaud A, Lin W, O'Keeffe B, Wang Y, Lu S, Spoerke JM, Huw LY, Byrtek M, Zhu R, Ware JA, Motzer RJ. Randomized Open-Label Phase II Trial of Apitolisib (GDC-0980), a Novel Inhibitor of the PI3K/Mammalian Target of Rapamycin Pathway, Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2016 May 10;34(14):1660-8. doi: 10.1200/JCO.2015.64.8808. Epub 2016 Mar 7.
Other Identifiers
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GO00885
Identifier Type: OTHER
Identifier Source: secondary_id
2011-000493-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PIM4973g
Identifier Type: -
Identifier Source: org_study_id
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