A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma
This study is currently recruiting participants.
Verified May 2013 by Seattle Genetics, Inc.
Sponsor:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01677390
First received: August 23, 2012
Last updated: May 1, 2013
Last verified: May 2013
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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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | July 2014 (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
- Prior treatment with an mTOR inhibitor
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677390
Contacts
| Contact: Terri Lowe | 866-333-7436 | clinicaltrials@seagen.com |
Locations
| United States, California | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Sarah Barbeau 650-723-6286 sbarbeau@stanford.edu | |
| Principal Investigator: Sandhya Srinivas, M.D. | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers - Midtown | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Heather Harsh heather.harsh@usoncology.com | |
| Principal Investigator: Allen Cohn, MD | |
| United States, Michigan | |
| Karmanos Cancer Institute / Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Cindy Silski 313-576-9368 silskic@karmanos.org | |
| Principal Investigator: Elisabeth Heath, MD | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Brittany Szabo 646-227-2170 szabob@mskcc.org | |
| Principal Investigator: Ana Molina, M.D. | |
| United States, Rhode Island | |
| Miriam Hospital, The | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Contact: Maureen Jean 401-793-4283 mjean@lifespan.org | |
| Principal Investigator: Anthony Mega, M.D. | |
| United States, Washington | |
| Seattle Cancer Care Alliance / University of Washington | Recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Taylor Hain 206-288-6272 tayloh@u.washington.edu | |
| Principal Investigator: John Thompson, M.D. | |
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
| Study Director: | Nancy Whiting, Pharm D, BCOP | 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: | May 1, 2013 |
| 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 Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013