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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 ]
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 ]
  • Progression-free survival [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 1 year ]
  • 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 ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Pre-dose in most cycles and 1 month post last dose ]
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
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01677390
SGN75-002
No
Not Provided
Not Provided
Not Provided
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