Cardiac Safety Study of Brentuximab Vedotin (SGN-35) | NCT01026233

Studies
Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

NCT01026233

Sponsor

Seagen Inc.

Status

Completed

Last Update Posted

Dec 12, 2014Estimated

Enrollment

52Actual

Phase

Phase 1

Conditions

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

Interventions

brentuximab vedotin

Countries

United States
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

YesNCT01196208No longer available

Start Date

Jan 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 3, 2009

First Posted Date

Dec 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2014

Last Update Posted Date

Dec 12, 2014Estimated

Name	Class
Millennium Pharmaceuticals, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Disease, Hodgkin
Drug Therapy
Hematologic Diseases
Immunotherapy
Lymphoma
monomethylauristatin E
Lymphoma, Large-Cell, Anaplastic

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	brentuximab vedotin	Drug: brentuximab vedotin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
brentuximab vedotin	Drug	1.8 mg/kg IV every 21 days	1	SGN-35

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QTc interval		2-4 days postdose

Secondary Outcomes

Measure	Description	Time Frame
ECG parameters		2-4 days postdose
Blood MMAE levels		Through 4 days postdose
Incidence of proarrhythmic adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Relapsed or refractory CD30-positive malignancy
Adequate organ function
ECOG performance status <2

Exclusion Criteria:

Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)
Current diagnosis of primary cutaneous ALCL
Acute or chronic graft-versus-host disease
Prior hematopoietic stem cell transplant within specified timeframe

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Naomi Hunder, MD	Seagen Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-3300	United States
City of Hope National Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23719719	Result	Han TH, Chen R, Advani R, Berryman RB, Smith SE, Forero-Torres A, Rosenblatt JD, Smith MR, Zain J, Hunder NN, Engert A. Brentuximab vedotin does not cause clinically relevant QTc interval prolongation in patients with CD30-positive hematologic malignancies. Cancer Chemother Pharmacol. 2013 Jul;72(1):241-9. doi: 10.1007/s00280-013-2192-z. Epub 2013 May 30.
22786877

ID	Term
D006689	Hodgkin Disease
D017728	Lymphoma, Large-Cell, Anaplastic
D008228	Lymphoma, Non-Hodgkin
D006402	Hematologic Diseases
D008223	Lymphoma

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized