NCT01164709

Nelfinavir Mesylate and Bortezomib in Treating Patients With Relapsed or Progressive Advanced Hematologic Cancer

Phase I Trial of Nelfinavir and Bortezomib in Advanced Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Nelfinavir mesylate and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of hematologic cancer by blocking blood flow to the cancer. Giving nelfinavir mesylate together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with bortezomib in treating patients with relapsed or progressive advanced hematologic cancer.

Detailed description

OBJECTIVES: * To assess the safety of nelfinavir mesylate in combination with bortezomib in patients with relapsed or progressive, advanced hematologic malignancies. * To establish the phase II recommended dose of nelfinavir mesylate in these patients. OUTLINE: This is a multicenter, dose-escalation study of nelfinavir mesylate. Patients receive oral nelfinavir mesylate twice daily on days 1-21 and bortezomib IV on days 8, 11, 15, and 18 in course 1. Course 1 has a duration of 28 days. Beginning in course 2, patients receive oral nelfinavir mesylate twice daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for 2 courses. Patients with responding disease may continue to receive nelfinavir mesylate and bortezomib for up to 4 additional courses. After completion of study treatment, patients are followed for 30 days.

Conditions

• Leukemia
• Lymphoma
• Mature T-cell and Nk-cell Neoplasms
• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	bortezomib	Bortezomib i.v., day 8, 11, 15, 18; 1.3 mg/m2
DRUG	nelfinavir mesylate	p.o., days 1 to 21; dose level: (625), 1250, 1875, or 2500 mg, 2x/d

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-07-01
• Completion: 2013-11-01
• First posted: 2010-07-19
• Last updated: 2019-05-15

Locations

4 sites across 1 country: Switzerland