An evaluation of the investigational drug GDC-0980 in patients with metastatic kidney cancer who have already received up to three therapies, with the approved drug everolimus as a comparison

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2011-000493-56-GB
• Date of registration: 21/09/2011
• Prospective Registration: Yes
• Primary sponsor: GENENTECH, Inc.
• Public title: An evaluation of the investigational drug GDC-0980 in patients with metastatic kidney cancer who have already received up to three therapies, with the approved drug everolimus as a comparison
• Scientific 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
• Date of first enrolment: 25/10/2011
• Target sample size: 85
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000493-56
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: yes; Other specify the comparator: everolimus; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Spain, United Kingdom, United States

Contacts

• Name: Trial Information Support Line,TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line,TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

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
•Age = 18 years
•Karnofsky Performance Status Score (KPSS) of = 70%
•Disease that is measurable per RECIST v1.1
•Adequate hematologic and end organ function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion criteria:
•Requirement for chronic antihyperglycemic therapy
•Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
•Decreased oxygen saturation with exercise (pulse oximeter <88%)
•Previously established diagnosis of pulmonary fibrosis of any cause
•Current unstable angina
•History of myocardial infarction within 6 months prior to Day 1
•New York Heart Association (NYHA) Class II or greater congestive heart failure
•Clinically significant liver disease
•Known HIV infection
•Active infection requiring IV antibiotics
•Active autoimmune or inflammatory disease that is not controlled by nonsteroidal anti inflammatory drugs; Patients with active Crohn’s disease or ulcerative colitis are not allowed.
•Pregnancy, lactation, or breastfeeding
•Leptomeningeal disease as a manifestation of cancer
•Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control).
•Hypersensitivity to any rapamycin derivatives or to any excipients of everolimus
•History of other malignancies <= 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

METASTATIC RENAL CELL CARCINOMA
MedDRA version: 14.1 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1 Level: LLT Classification code 10038409 Term: Renal cell carcinoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: GDC-0980
Product Code: GDC-0980 (RO5490254)
Pharmaceutical Form: Film-coated tablet
CAS Number: 1032754-93-0
Current Sponsor code: GDC-0980 (RO5490254)
Other descriptive name: PI3K/mTOR INHIBITOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Afinitor 5 mg tablets
Product Name: everolimus
Pharmaceutical Form: Tablet
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Afinitor 10 mg tablets
Product Name: everolimus
Pharmaceutical Form: Tablet
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: •To evaluate the efficacy of GDC-0980 versus everolimus as measured by progression-free survival (PFS) defined as the time from randomization to disease progression

Timepoint(s) of evaluation of this end point: After approximately 60 PFS events have occurred (estimated to occur approximately 23 months after study start).

Secondary Objective: •To assess the clinical activity of GDC-0980 versus everolimus as measured by response rate, duration of response, and overall survival (OS)
•To evaluate the safety and tolerability of GDC-0980 versus everolimus
•To assess pharmacokinetic (PK) parameters (Cmax, Cmin) of GDC 0980 and everolimus

Primary end point(s): Progression-free survival (PFS)

Secondary Outcome(s)

Secondary end point(s): Response rate, duration of response, overall survival, safety, tolerability, PK parameters

Timepoint(s) of evaluation of this end point: Final analyses after approximately 60 PFS events have occurred. Interim analyses for safety and PK parameters after the first 10 patients in each arm have undergone the first tumor assessment while receiving study treatment (GDC-0980 or everolimus); and again when the same is the case for 20 and 30 patients in each arm.

Secondary ID(s)

2011-000493-56-ES

PIM4973g

Source(s) of Monetary Support

Genentech Inc. c/o F. Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 08/07/2016
• Date Completed: 23/06/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-000493-56/results