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

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ClinicalTrials.gov Identifier: NCT01677390
Recruitment Status : Terminated
First Posted : September 3, 2012
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: SGN-75 Drug: everolimus Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
SGN-75, everolimus
Drug: SGN-75
1-2 mg/kg IV every 21 days
Drug: everolimus
10 mg PO daily


Outcome Measures

Primary Outcome Measures :
  1. Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month post last dose ]

Secondary Outcome Measures :
  1. Best clinical response according to RECIST Version 1.1 [ Time Frame: Through 1 month post last dose ]
  2. Progression-free survival [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months ]
  3. Overall survival [ Time Frame: Until death or study closure, an expected average of 1 year ]
  4. 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 ]
  5. Incidence of antitherapeutic antibodies [ Time Frame: Pre-dose in most cycles and 1 month post last dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01677390     History of Changes
Other Study ID Numbers: SGN75-002
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

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
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents