A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

NCT00649584 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-12-18

No results posted yet for this study

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.

Conditions

  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin

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

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Dana Kennedy, PharmD · Seagen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00649584 on ClinicalTrials.gov