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

February 11, 2008 updated by: Myrexis Inc.

Phase 1 Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Brain Metastases

Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.

Study Overview

Status

Completed

Conditions

Brain Neoplasms

Intervention / Treatment

Drug: MPC-6827

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics Time Frame: 1 year	1 year
Maximum Tolerated Dose Time Frame: 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Antitumor Activity Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myrexis Inc.

Investigators

Study Director: Margaret Yu, MD, Myrexis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 30, 2006

First Submitted That Met QC Criteria