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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01677390
• Other study ID #: SGN75-002
• Status: Terminated
• Phase: Phase 1
• First received: August 23, 2012
• Last updated: January 24, 2014
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• SGN-75
1-2 mg/kg IV every 21 days
• everolimus
10 mg PO daily

Locations

Country	Name	City	State
United States	UNC Lineberger Comprehensive Cancer Center / University of North Carolina	Chapel Hill	North Carolina
United States	Rocky Mountain Cancer Centers - Midtown	Denver	Colorado
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Miriam Hospital, The	Providence	Rhode Island
United States	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington
United States	Stanford Cancer Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and laboratory abnormalities		Through 1 month post last dose	Yes
Secondary	Best clinical response according to RECIST Version 1.1		Through 1 month post last dose	No
Secondary	Progression-free survival		Until disease progression or start of new anticancer treatment, an expected average of 6 months	No
Secondary	Overall survival		Until death or study closure, an expected average of 1 year	No
Secondary	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	No
Secondary	Incidence of antitherapeutic antibodies		Pre-dose in most cycles and 1 month post last dose	Yes