deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00064324

Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma

A Phase II Study of Perifosine in Soft Tissue Sarcoma

Sponsor: National Cancer Institute (NCI)

Updated 7 times since 2017 Last updated: Jun 3, 2013 Started: Jun 30, 2003 Primary completion: Nov 30, 2005
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Recurrent Adult Soft Tissue Sarcoma and Stage III Adult Soft Tissue Sarcoma, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 7 data snapshots since 2003. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To evaluate the 6-month progression-free rate in patients treated with perifosine and having advanced soft tissue sarcoma. SECONDARY OBJECTIVES: I. To evaluate survival and time to progression. II. To evaluate objective tumor response status and duration. III. To evaluate adverse event rates. IV. To evaluate patterns of treatment failure. V. To evaluate pharmacokinetics. OUTLINE: This is a multicenter study. Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 17-46 patients will be accrued for this study within 9-12 months.

PRIMARY OBJECTIVES:

I. To evaluate the 6-month progression-free rate in patients treated with perifosine and having advanced soft tissue sarcoma.

SECONDARY OBJECTIVES:

I. To evaluate survival and time to progression. II. To evaluate objective tumor response status and duration. III. To evaluate adverse event rates. IV. To evaluate patterns of treatment failure. V. To evaluate pharmacokinetics.

OUTLINE: This is a multicenter study.

Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 17-46 patients will be accrued for this study within 9-12 months.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Jun 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations