Mechanism of Action of Galiximab in Subjects With Previou... | NCT00651443

Studies
Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma

NCT00651443

Sponsor

Biogen

Status

Terminated

Last Update Posted

Jan 7, 2011Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Lymphoma, Non-Hodgkin's

Interventions

Galiximab

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

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Nov 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 31, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 2, 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

Jan 6, 2011

Last Update Posted Date

Jan 7, 2011Estimated

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

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

20Estimated

Label	Type	Description	Intervention Names
1	Experimental		Drug: Galiximab

Name	Type	Description	Arm Group Labels	Other Names
Galiximab	Drug	Galiximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.		24 months

Secondary Outcomes

Measure	Description	Time Frame
1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab.		48 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent (signed and dated).
Age equal or greater than 18 at the time of consent.
Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
At least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
Acceptable hematologic, hepatic, and renal function parameters.
WHO Performance Status equal or less than 2.
Subjects of reproductive potential must agree to follow accepted birth control methods.

Exclusion Criteria:

Presence of lymphoma in CNS.
Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
Concurrent treatment with systemic steroids within 14 days of Day 1.
Evidence of transformed lymphoma.
Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
History of HIV infection or AIDS.
Serious nonmalignant disease.
Pregnant.
Inability to comply with study and follow-up procedures.
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.

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

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders