Back to resultsA Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-75
everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Antibody-Drug Conjugate, monomethylauristatin F, Carcinoma, Renal Cell, Antigens, CD70, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression
- Previously treated with at least 1 tyrosine kinase inhibitor (TKI)
- Measurable disease
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate lung and renal function
Exclusion Criteria:
- Prior treatment with anti-CD70-directed therapy
- Received more than one prior treatment with an mTOR inhibitor
Sites / Locations
- Stanford Cancer Center
- Rocky Mountain Cancer Centers - Midtown
- Karmanos Cancer Institute / Wayne State University
- Memorial Sloan Kettering Cancer Center
- UNC Lineberger Comprehensive Cancer Center / University of North Carolina
- Miriam Hospital, The
- Sarah Cannon Research Institute
- Seattle Cancer Care Alliance / University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
SGN-75, everolimus
Outcomes
Primary Outcome Measures
Incidence of adverse events and laboratory abnormalities
Secondary Outcome Measures
Best clinical response according to RECIST Version 1.1
Progression-free survival
Overall survival
Blood concentrations of SGN-75 and metabolites
Incidence of antitherapeutic antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01677390
Brief Title
A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma
Official Title
A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Antibody-Drug Conjugate, monomethylauristatin F, Carcinoma, Renal Cell, Antigens, CD70, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
SGN-75, everolimus
Intervention Type
Drug
Intervention Name(s)
SGN-75
Intervention Description
1-2 mg/kg IV every 21 days
Intervention Type
Drug
Intervention Name(s)
everolimus
Intervention Description
10 mg PO daily
Primary Outcome Measure Information:
Title
Incidence of adverse events and laboratory abnormalities
Time Frame
Through 1 month post last dose
Secondary Outcome Measure Information:
Title
Best clinical response according to RECIST Version 1.1
Time Frame
Through 1 month post last dose
Title
Progression-free survival
Time Frame
Until disease progression or start of new anticancer treatment, an expected average of 6 months
Title
Overall survival
Time Frame
Until death or study closure, an expected average of 1 year
Title
Blood concentrations of SGN-75 and metabolites
Time Frame
Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
Title
Incidence of antitherapeutic antibodies
Time Frame
Pre-dose in most cycles and 1 month post last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression
Previously treated with at least 1 tyrosine kinase inhibitor (TKI)
Measurable disease
Eastern Cooperative Oncology Group performance status 0 or 1
Adequate lung and renal function
Exclusion Criteria:
Prior treatment with anti-CD70-directed therapy
Received more than one prior treatment with an mTOR inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaina Gartner, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Miriam Hospital, The
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma
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