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:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01015911
First received: November 13, 2009
Last updated: September 17, 2014
Last verified: September 2014
  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
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: 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

Publications:
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: September 17, 2014
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
Adenocarcinoma
Immune System Diseases
Immunoproliferative Disorders
Kidney Diseases
Kidney Neoplasms
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014