PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients

• Status: Not yet recruiting
• Trial end date: 2020-10-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acrotech Biopharma LLC
• Collaborator: Axis Clinicals Limited
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Vincristine

Criteria

Key Inclusion Criteria:

• Patient has a hematological malignancy and is eligible to receive CHOP or R-CHOP regimen.

• Patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment:

• Patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment.

Key Exclusion Criteria:

• Patient has severe neurologic disorders (Grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy.

• Patient has a history of persistent active neurologic disorders including the demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.

• Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.

• Patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation.

• Patient has severe, active and uncontrolled hepatic disease or dysfunction.