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

NCT ID: NCT00430846

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Antigens,CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Lymphoma, Non-Hodgkin Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Hematologic Diseases Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

SGN-35

Intervention Type DRUG

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

Interventions

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SGN-35

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

Intervention Type DRUG

Other Intervention Names

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brentuximab vedotin

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andres Forero, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Anas Younes, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Nancy Bartlett, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

John Leonard, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Dana Kennedy, PharmD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

University of Texas/MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21047225 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32596842 (View on PubMed)

Other Identifiers

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SG035-0001

Identifier Type: -

Identifier Source: org_study_id

NCT00412282

Identifier Type: -

Identifier Source: nct_alias