NCT00393965

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 13, 2008

Status Verified

February 1, 2008

Enrollment Period

1.7 years

First QC Date

October 30, 2006

Last Update Submit

February 11, 2008

Conditions

Brain Neoplasms

Keywords

MetastasesRefractoryBrain

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose

    1 year

  • Pharmacokinetics

    1 year

Secondary Outcomes (1)

  • Antitumor Activity

    2 years

Interventions

MPC-6827DRUG

2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsNeoplasm Metastasis

Interventions

verubulin

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret Yu, MD

    Myrexis Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 30, 2006

First Posted

October 31, 2006

Study Start

December 1, 2005

Primary Completion

August 1, 2007

Study Completion

February 1, 2008

Last Updated

February 13, 2008

Record last verified: 2008-02

Locations

US(1)