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

NCT01442090 | Completed Phase 2

• 3 other identifiers: PIM4973gGO008852011-000493-56
• Study Type: interventional
• Target: 85
• Locations: 5 countries
• Sites: 22

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (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 Outcomes (8)

• 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)

• 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

• 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

• Cmin of everolimus

  pre-dose on Week 1 Day 1 and Week 9 Day 1

• Number of participants with adverse events

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

Study Arms (2)

Everolimus

ACTIVE COMPARATOR

Participants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.

Drug: Everolimus

GDC-0980

EXPERIMENTAL

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

Interventions

Everolimus DRUG

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

Everolimus

GDC-0980 DRUG

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

GDC-0980

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (22)

Unknown Facility

Fort Myers, Florida, 33908, United States

Location

Unknown Facility

St. Petersburg, Florida, 33705, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Las Vegas, Nevada, 89148, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Bordeaux, 33075, France

Location

Unknown Facility

Paris, 75908, France

Location

Unknown Facility

Villejuif, 94800, France

Location

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

München, 81377, Germany

Location

Unknown Facility

Barcelona, Barcelona, 08003, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Madrid, Madrid, 28041, Spain

Location

Unknown Facility

Leeds, LS9 7TF, United Kingdom

Location

Unknown Facility

London, EC1A 7BE, United Kingdom

Location

Unknown Facility

London, SW3 6JJ, United Kingdom

Location

Unknown Facility

Manchester, M20 4BX, United Kingdom

Location

Unknown Facility

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26951309 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Everolimus; 1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2015
• Last Updated: August 10, 2016

Record last verified: 2016-05

Locations

GB (5); US (8); DE (3); FR (3); ES (3)