Study Stopped
Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.
A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
1 other identifier
interventional
44
1 country
5
Brief Summary
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 27, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedDecember 18, 2014
December 1, 2014
1.9 years
March 27, 2008
December 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events and laboratory abnormalities
1 month after last dose
Secondary Outcomes (3)
PK profile
2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)
1 month after last dose
Anti-tumor activity
1 month after last dose
Study Arms (1)
1
EXPERIMENTALSGN-35 alone or in combination with gemcitabine
Interventions
IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
Eligibility Criteria
You may qualify if:
- Histologically confirmed CD30-positive hematologic malignancy.
- Patients with HL must have failed systemic chemotherapy.
- Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
- Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.
You may not qualify if:
- Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
- History of allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (5)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
University of Miami
Miami, Florida, 33136, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4003, United States
Related Publications (1)
Fanale MA, Forero-Torres A, Rosenblatt JD, Advani RH, Franklin AR, Kennedy DA, Han TH, Sievers EL, Bartlett NL. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012 Jan 1;18(1):248-55. doi: 10.1158/1078-0432.CCR-11-1425. Epub 2011 Nov 11.
PMID: 22080439RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dana Kennedy, PharmD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2008
First Posted
April 1, 2008
Study Start
March 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
December 18, 2014
Record last verified: 2014-12