NCT00394446

Brief Summary

Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

March 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
10 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

2.1 years

First QC Date

October 30, 2006

Last Update Submit

February 11, 2008

Conditions

Refractory Solid Tumors

Keywords

Solid TumorsRefractoryBrain

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose

    1 year

  • Pharmacokinetics

    22 months

Secondary Outcomes (1)

  • Antitumor Activity

    2 years

Interventions

MPC-6827DRUG

2-hour intravenous 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:

  • Advanced or Metastatic Cancer
  • Measurable / Evaluable Disease
  • Karnofsky score greater than or equal to 70%
  • 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 (2)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

verubulin

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

November 1, 2006

Study Start

March 1, 2005

Primary Completion

April 1, 2007

Study Completion

February 1, 2008

Last Updated

February 13, 2008

Record last verified: 2008-02

Locations

US(2)