A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma - Full Text View

Sponsor:	Seattle Genetics, Inc.
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01015911

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 I

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:

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

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 ]

Estimated Enrollment:	113
Study Start Date:	November 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	January 2012 (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
UAB Comprehensive Cancer Center
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:	November 30, 2011
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 February 02, 2012