deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT00233948

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

Updated 8 times since 2017 Last updated: Mar 30, 2015 Started: Mar 31, 2006 Primary completion: Jul 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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this PHASE1/PHASE2 trial focuses on Adult Liposarcoma and Recurrent Adult Soft Tissue Sarcoma and remains terminated or withdrawn.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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 7 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE1_PHASE2

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE1_PHASE2

  2. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE1_PHASE2

  3. 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

Sponsor contact:
  • City of Hope Medical Center
Data source: City of Hope Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .