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A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Malignant Uveal Melanoma

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Trial Information

A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma

Inclusion Criteria:

- Uveal melanoma with histologic or cytologic confirmation of metastatic disease.

- One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at
least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion,
it must be >20 mm with conventional techniques or >10 mm with spiral CT scan. Bone
lesions are not considered measurable.

- Must not have received any prior systemic chemotherapy, immunotherapy, vaccine or
hepatic arterial chemotherapy for metastatic disease.

- Adequate liver, renal, and bone marrow function.

- Zubrod performance status of 0-2.

- Sign an informed consent form.

Exclusion Criteria:

- Major surgery within 4 weeks of enrollment.

- Advanced symptomatic central nervous system (CNS) involvement by melanoma and those
on phenytoin or requiring steroids for brain metastases, spinal cord compression, or
meningeal "carcinomatosis".

- History of neurological disorders unrelated to chemotherapy (including familial
neurological diseases and acquired demyelinating disorders).

- Grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any

- Receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by
cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate.

Outcome Time Frame:

Every 6 weeks

Safety Issue:


Principal Investigator

Deborah Sanders, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson


United States: Food and Drug Administration

Study ID:

HBS408 (formerly IST401)



Start Date:

November 2007

Completion Date:

July 2013

Related Keywords:

  • Metastatic Malignant Uveal Melanoma
  • Melanoma
  • Uveal Neoplasms



Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
University of Texas M.D. Anderson Cancer Center Houston, Texas  77030
University of California, Los Angeles Los Angeles, California  
University of Colorado, Denver Aurora, Colorado  80045