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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