A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma
This study has been completed.
Sponsor:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01015911
First received: November 13, 2009
Last updated: July 20, 2012
Last verified: July 2012
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Purpose
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell Lymphoma, Non-Hodgkin |
Drug: SGN-75 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or 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 following last dose ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Best clinical response [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
- Duration of response, progression-free survival [ Time Frame: Every 3 months until progression of disease or initiation of new treatment for cancer ] [ Designated as safety issue: No ]
- Blood concentrations of SGN-75 and metabolites [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
- Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 58 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
SGN-75
|
Drug: SGN-75
SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically-confirmed diagnosis of NHL or RCC
- Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
- Confirmed CD70 expression
- Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC
Exclusion Criteria:
- Previously received an allogeneic transplant
- History of another primary malignancy that has not been in remission for at least 3 years
- Prior anti-CD70-directed therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015911
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, California | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010-3000 | |
| UCLA Medical Center / University of California at Los Angeles | |
| Los Angeles, California, United States, 90095-1678 | |
| United States, Michigan | |
| Karmanos Cancer Institute / Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| MD Anderson Cancer Center / University of Texas | |
| Houston, Texas, United States, 77030 | |
| 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: | Nancy Whiting, PharmD, BCOP | Seattle Genetics, Inc. |
More Information
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01015911 History of Changes |
| Other Study ID Numbers: | SGN75-001 |
| Study First Received: | November 13, 2009 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Genetics, Inc.:
|
Antibodies, Monoclonal Antibody-Drug Conjugate Antigens, CD70 Lymphoma, Non-Hodgkin |
Carcinoma, Renal Cell Immunotherapy Drug Therapy monomethylauristatin F |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Lymphoma Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013