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Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

NCT00430846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-12-18

No results posted yet for this study

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 I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

Conditions

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

Interventions

DRUG

SGN-35

Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Andres Forero, MD · University of Alabama at Birmingham

  • Anas Younes, MD · M.D. Anderson Cancer Center

  • Nancy Bartlett, MD · Washington University School of Medicine

  • John Leonard, MD · Weill Medical College of Cornell University

  • Dana Kennedy, PharmD · Seagen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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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 NCT00430846 on ClinicalTrials.gov