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

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393965
• Other study ID #: MPC-6827-04-002
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2006
• Last updated: February 11, 2008
• Start date: December 2005
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Drug:
• MPC-6827
2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		1 year	Yes
Primary	Pharmacokinetics		1 year	No
Secondary	Antitumor Activity		2 years	No