A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
Overview
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.
Full Title of Study: “A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: February 2010
Interventions
- Drug: SGN-35
- IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
- Drug: gemcitabine
- IV; 1000 mg/m2 weekly 3 out of 4 weeks
Arms, Groups and Cohorts
- Experimental: 1
- SGN-35 alone or in combination with gemcitabine
Clinical Trial Outcome Measures
Primary Measures
- Incidence of adverse events and laboratory abnormalities
- Time Frame: 1 month after last dose
Secondary Measures
- PK profile
- Time Frame: 2 months after last dose
- Immunogenicity (anti-SGN-35 antibodies)
- Time Frame: 1 month after last dose
- Anti-tumor activity
- Time Frame: 1 month after last dose
Participating in This Clinical Trial
Inclusion Criteria
- 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. Exclusion Criteria:
- 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.
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Seagen Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Dana Kennedy, PharmD, Study Director, Seagen Inc.
Citations Reporting on Results
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.
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