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

Tracking Information

First Received Date ^ICMJE

March 27, 2008

Last Updated Date

October 7, 2011

Start Date ^ICMJE

March 2008

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Adverse events; clinical laboratory parameters. [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00649584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

PK Profile; Immunogenicity; Cheson Response Criteria. [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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

Study Arms

Experimental: 1

SGN-35 alone or in combination with gemcitabine

Interventions:

Drug: SGN-35
Drug: gemcitabine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00649584

Other Study ID Numbers ^ICMJE

SG035-0002

Has Data Monitoring Committee

Responsible Party

Seattle Genetics, Inc.

Study Sponsor ^ICMJE

Seattle Genetics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Dana Kennedy, PharmD

Seattle Genetics, Inc.

Information Provided By

Seattle Genetics, Inc.

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP