Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
A Phase I/II Study of Nelfinavir in Liposarcoma
Sponsor: City of Hope Medical Center
Terminated
Drug availability issues
Listed as NCT00233948, this PHASE1/PHASE2 trial focuses on Adult Liposarcoma and Recurrent Adult Soft Tissue Sarcoma and remains terminated or withdrawn. Sponsored by City of Hope Medical Center, it has been updated 8 times since 2006, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)OBJECTIVES:
I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma.
II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single agent and to describe the toxicities at each does studied.
III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and progression free survival in patients with liposarcoma treated with nelfinavir.
V. To evaluate the expression and activity of certain proteins in the tumors of patients entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1, p21, NFkB (NFkappaB), caspase 3).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma.
II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single agent and to describe the toxicities at each does studied.
III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and progression free survival in patients with liposarcoma treated with nelfinavir.
V. To evaluate the expression and activity of certain proteins in the tumors of patients entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1, p21, NFkB (NFkappaB), caspase 3).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE1/PHASE2
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Dec 2021 — Jul 2024 [monthly]
Terminated PHASE1_PHASE2
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Jan 2021 — Dec 2021 [monthly]
Terminated PHASE1_PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Terminated PHASE1_PHASE2
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Feb 2017 — Jun 2018 [monthly]
Terminated PHASE1_PHASE2
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Jan 2017 — Feb 2017 [monthly]
Terminated PHASE1_PHASE2
First recorded
Mar 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- City of Hope Medical Center
For direct contact, visit the study record on ClinicalTrials.gov .