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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01677390
First received: August 23, 2012
Last updated: January 24, 2014
Last verified: January 2014

August 23, 2012
January 24, 2014
August 2012
December 2013   (final data collection date for primary outcome measure)
Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01677390 on ClinicalTrials.gov Archive Site
  • Best clinical response according to RECIST Version 1.1 [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Pre-dose in most cycles and 1 month post last dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Drug: SGN-75
    1-2 mg/kg IV every 21 days
  • Drug: everolimus
    10 mg PO daily
Experimental: Arm 1
SGN-75, everolimus
Interventions:
  • Drug: SGN-75
  • Drug: everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01677390
SGN75-002
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Elaina Gartner, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP