A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma

Phase 1

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: SGN-75; Drug: everolimus

• Registration Number: NCT01677390
• Lead Sponsor: Seagen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	SGN-75	SGN-75, everolimus
Arm 1	everolimus	SGN-75, everolimus

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and laboratory abnormalities	Through 1 month post last dose

Secondary Outcome Measures

Name	Time	Method
Best clinical response according to RECIST Version 1.1	Through 1 month post last dose
Overall survival	Until death or study closure, an expected average of 1 year
Blood concentrations of SGN-75 and metabolites	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
Incidence of antitherapeutic antibodies	Pre-dose in most cycles and 1 month post last dose
Progression-free survival	Until disease progression or start of new anticancer treatment, an expected average of 6 months

Trial Locations

Locations (8)

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Rocky Mountain Cancer Centers - Midtown; 🇺🇸 Denver, Colorado, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

UNC Lineberger Comprehensive Cancer Center / University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Miriam Hospital, The; 🇺🇸 Providence, Rhode Island, United States

Karmanos Cancer Institute / Wayne State University; 🇺🇸 Detroit, Michigan, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Seattle Cancer Care Alliance / University of Washington; 🇺🇸 Seattle, Washington, United States