NCT00430846

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

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

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

February 1, 2007

Last Update Submit

December 17, 2014

Conditions

Lymphoma, Non-HodgkinDisease, HodgkinLymphoma, Large-Cell, Anaplastic

Keywords

Antigens,CD30Antibody-Drug ConjugateAntibodies, MonoclonalLymphoma, Non-HodgkinDisease, HodgkinLymphoma, Large-Cell, AnaplasticHematologic DiseasesLymphoma

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)

A

EXPERIMENTAL
Drug: SGN-35

Interventions

SGN-35DRUG

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

Also known as: brentuximab vedotin
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically confirmed CD30-positive hematologic malignancy.
  • Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
  • Patients must have measurable disease of at least 10mm as documented by radiographic technique.
  • Must be at least 18 years of age.

You may not qualify if:

  • Patients with current diagnosis of pcALCL (systemic ALCL eligible).
  • Patients with 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

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

University of Texas/MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21. doi: 10.1056/NEJMoa1002965.

    PMID: 21047225RESULT

  • Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28.

    PMID: 32596842DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, AnaplasticHematologic DiseasesLymphoma

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Andres Forero, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Anas Younes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

  • Nancy Bartlett, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • John Leonard, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Dana Kennedy, PharmD

    Seagen Inc.

    STUDY DIRECTOR

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

February 1, 2007

First Posted

February 2, 2007

Study Start

November 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(4)