Phase 1 Study of MDX-1401 in Patients With CD30-positive... | NCT00634452

Studies
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

NCT00634452

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Dec 6, 2012Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Hodgkin's Lymphomas

Interventions

MDX-1401

Countries

United States

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

ID	Type	Description	Link
CA213-001	Other Identifier	BMS

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Mar 7, 2008

First Posted Date

Mar 13, 2008Estimated

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 5, 2012

Last Update Posted Date

Dec 6, 2012Estimated

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

To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).

Detailed Description

Not provided

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDX-1401	Experimental	MDX-1401 iv at various doses	Biological: MDX-1401

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MDX-1401	Biological	IV weekly for 4 weeks	MDX-1401

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability Profile		Two years

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)		Day 50
Tumor response assessment		Two year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
Bi-measurable disease
ECOG Performance Status of 0 - 2
Meet all screening laboratory values

Exclusion Criteria:

Previous treatment with any other anti-CD30 antibody
History of allogeneic transplant
Any tumor lesion greater than or equal to 10 cm in diameter
Any active or chronic significant infection
Underlying medical condition which will make the administration of MDX- 1401 hazardous
Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Winship Cancer Institute, Emory University		Atlanta	Georgia	30322	United States
Northwestern University Feinberg School of Medicine

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease
D009369	Neoplasms
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C542433	MDX-1401

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided