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
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Drug: SGN-75
Drug: everolimus
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
SGN-75, everolimus
Drug: SGN-75
1-2 mg/kg IV every 21 days
Drug: everolimus
10 mg PO daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677390

Locations
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States, 80218
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Rhode Island
Miriam Hospital, The
Providence, Rhode Island, United States, 02906
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Washington
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Elaina Gartner, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01677390     History of Changes
Other Study ID Numbers: SGN75-002
Study First Received: August 23, 2012
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
monomethylauristatin F
Carcinoma, Renal Cell
Antigens, CD70
Drug Therapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014