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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00393965

Enrollment

Registered

2006-10-31

Start date

2005-12-31

Completion date

2008-02-29

Last updated

2008-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

Keywords

Metastases, Refractory, Brain

Brief summary

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

Interventions

DRUGMPC-6827

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Maximum Tolerated Dose	1 year
Pharmacokinetics	1 year

Secondary

Measure	Time frame
Antitumor Activity	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026