Multiple Dose Study of MPC-6827 in Subjects With Refracto... | NCT00393965

Studies
Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases

NCT00393965

Sponsor

Myrexis Inc.

Status

Completed

Last Update Posted

Feb 13, 2008Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Brain Neoplasms

Interventions

MPC-6827

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

Feb 2008

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

Dec 2005

Primary Completion Date

Aug 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

Oct 30, 2006

First Submission Date that Met QC Criteria

Oct 30, 2006

First Posted Date

Oct 31, 2006Estimated

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

Feb 11, 2008

Last Update Posted Date

Feb 13, 2008Estimated

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

18Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MPC-6827	Drug	2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.

Measure	Description	Time Frame
Maximum Tolerated Dose		1 year
Pharmacokinetics		1 year

Measure	Description	Time Frame
Antitumor Activity		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Refractory Brain Metastases
At least 1 measurable intracranial lesion as defined by RECIST
ECOG less than or equal to 1
Adequate hematology/organ function
No baseline peripheral or central neuropathy above grade 1

Exclusion Criteria:

Hypersensitivity to Cremophor EL
Pregnant or Lactating
Spinal Cord Compression
Pre-existing dementia/cognitive disfunction
Require Neupogen or Neulasta to Maintain Neutrophil Count
Have Primary Brain Cancer
Have History of Ischemic Heart Disease
Have Diabetes

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
Margaret Yu, MD	Myrexis Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522974	verubulin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided