Status:
COMPLETED
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
Lead Sponsor:
Seagen Inc.
Conditions:
Lymphoma, Non-Hodgkin
Disease, Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00430846
Start Date
November 1 2006
End Date
July 1 2009
Last Update
December 18 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Washington University
St Louis, Missouri, United States, 63110
3
Weill Cornell Medical College
New York, New York, United States, 10021
4
University of Texas/MD Anderson Cancer Center
Houston, Texas, United States, 77030