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

Phase I 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 Solid Tumors.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00394446
Enrollment
48
Registered
2006-11-01
Start date
2005-03-31
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

Refractory Solid Tumors

Keywords

Solid Tumors, Refractory, Brain

Brief summary

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

Interventions

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

Sponsors

Myrexis Inc.
Lead SponsorINDUSTRY

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
No

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

Design outcomes

Primary

MeasureTime frame
Maximum Tolerated Dose1 year
Pharmacokinetics22 months

Secondary

MeasureTime frame
Antitumor Activity2 years

Countries

United States

Outcome results

None listed

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