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

NCT ID: NCT00649584

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal monomethyl auristatin E Combined Modality Therapy Drug Therapy Immunotherapy 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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1

SGN-35 alone or in combination with gemcitabine

Group Type EXPERIMENTAL

SGN-35

Intervention Type DRUG

IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles

gemcitabine

Intervention Type DRUG

IV; 1000 mg/m2 weekly 3 out of 4 weeks

Interventions

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SGN-35

IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles

Intervention Type DRUG

gemcitabine

IV; 1000 mg/m2 weekly 3 out of 4 weeks

Intervention Type DRUG

Other Intervention Names

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brentuximab vedotin Gemzar

Eligibility Criteria

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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.
Minimum Eligible Age

12 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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Dana Kennedy, PharmD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Stanford University Medical Center

Palo Alto, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, 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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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.

Reference Type RESULT
PMID: 22080439 (View on PubMed)

Other Identifiers

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SG035-0002

Identifier Type: -

Identifier Source: org_study_id