Clinical trial NCT01677390: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Cell Carcinoma
Keywords: Antibody-Drug Conjugate
monomethylauristatin F
Carcinoma, Renal Cell
Antigens, CD70
Drug Therapy
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: Through 1 month post last dose
Secondary outcomes:
measure: Best clinical response according to RECIST Version 1.1
timeFrame: Through 1 month post last dose
measure: Progression-free survival
timeFrame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
measure: Overall survival
timeFrame: Until death or study closure, an expected average of 1 year
measure: Blood concentrations of SGN-75 and metabolites
timeFrame: 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
measure: Incidence of antitherapeutic antibodies
timeFrame: Pre-dose in most cycles and 1 month post last dose
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Midtown
state: Colorado
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina
state: North Carolina
city: Providence
country: United States
facility: Miriam Hospital, The
state: Rhode Island
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Elaina Gartner, MD
role: STUDY_DIRECTOR
References: