Trial record 5 of 53 for:    SGN-35

Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00430846
First received: February 1, 2007
Last updated: June 6, 2013
Last verified: October 2011

February 1, 2007
June 6, 2013
November 2006
July 2009   (final data collection date for primary outcome measure)
Incidence of adverse events and laboratory abnormalities [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]
  • Response Criteria for NHL
  • International Workshop
Complete list of historical versions of study NCT00430846 on ClinicalTrials.gov Archive Site
  • PK profile [ Time Frame: 2 months after last dose ] [ Designated as safety issue: No ]
  • Immunogenicity (anti-SGN-35 antibodies) [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]
  • Anti-tumor activity [ Time Frame: 1 month after last dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.

Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma, Non-Hodgkin
  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
Drug: SGN-35
Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
Other Name: brentuximab vedotin
Experimental: A
Intervention: Drug: SGN-35
Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically confirmed CD30-positive hematologic malignancy.
  • Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
  • Patients must have measurable disease of at least 10mm as documented by radiographic technique.
  • Must be at least 18 years of age.

Exclusion Criteria:

  • Patients with current diagnosis of pcALCL (systemic ALCL eligible).
  • Patients with history of allogeneic stem cell transplant.
  • Patients who have had previous treatment with any anti-CD30 antibody.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00430846
SG035-0001
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Principal Investigator: Andres Forero, MD University of Alabama at Birmingham
Principal Investigator: Anas Younes, MD M.D. Anderson Cancer Center
Principal Investigator: Nancy Bartlett, MD Washington University Early Recognition Center
Principal Investigator: John Leonard, MD Weill Medical College of Cornell University
Study Director: Dana Kennedy, PharmD Seattle Genetics, Inc.
Seattle Genetics, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP