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

Phase 1CompletedNCT00394446

Myrexis Inc.48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Refractory Solid Tumors

Interventions

MPC-6827DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Advanced or Metastatic Cancer 2. Measurable / Evaluable Disease 3. Karnofsky score greater than or equal to 70% 4. Adequate Hematology / Organ function 5. No Baseline peripheral or central neuropathy above grade 1 Exclusion Criteria: 1. Hypersensitivity to Cremophor EL 2. Pregnant or Lactating 3. Spinal Cord Compression 4. Pre-existing Dementia / Cognitive Disfunction 5. Require Neupogen or Neulasta to Maintain Neutrophil Count 6. Have Primary Brain Cancer 7. Have history of Ischemic Heart Disease 8. Have Diabetes

Locations (2)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Maximum Tolerated Dose

Time frame: 1 year

Pharmacokinetics

Time frame: 22 months

Secondary Outcomes

Antitumor Activity

Time frame: 2 years

Data from ClinicalTrials.gov

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