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

This study has been terminated.

( Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy. )

First Received on March 27, 2008. Last Updated on October 7, 2011 History of Changes

Sponsor:	Seattle Genetics, Inc.
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00649584

Purpose

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.

Condition	Intervention	Phase
Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin	Drug: SGN-35 Drug: gemcitabine	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Incidence of adverse events and laboratory abnormalities [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK profile [ Time Frame: 2 months after last dose ] [ Designated as safety issue: No ]
Immunogenicity (anti-SGN-35 antibodies) [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]
Anti-tumor activity [ Time Frame: 1 month after last dose ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	March 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 SGN-35 alone or in combination with gemcitabine	Drug: SGN-35 IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles Other Name: brentuximab vedotin Drug: gemcitabine IV; 1000 mg/m2 weekly 3 out of 4 weeks Other Name: Gemzar

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649584

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4003

Sponsors and Collaborators

Seattle Genetics, Inc.

Investigators

Study Director:

Dana Kennedy, PharmD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00649584 History of Changes
Other Study ID Numbers:	SG035-0002
Study First Received:	March 27, 2008
Last Updated:	October 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

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

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell
Gemcitabine

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012