deltatrials
Completed PHASE2 INTERVENTIONAL NCT00020202

FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer

Phase II Study of FR901228 in Patients With Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Interventions FR901228
Updated 6 times since 2017 Last updated: Feb 29, 2024 Started: Jun 30, 2000 Completion: Mar 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Extensive Stage Small Cell Lung Cancer and Recurrent Non-small Cell Lung Cancer and is currently completed. National Cancer Institute (NCI) leads this study, which shows 6 recorded versions since 2000 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

OBJECTIVES: I. Determine the response of patients with refractory or progressive small cell or non-small cell lung cancer to FR901228. II. Determine the ability of FR901228 to mediate apoptosis and target gene induction relative to tumor histology in these patients. III. Determine the toxicity of this treatment in these patients. PROTOCOL OUTLINE: Patients are stratified according to disease histology (small cell lung cancer vs non-small cell lung cancer). Patients receive FR901228 IV over 4 hours on days 1 and 7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-43 patients (9-21 per arm) will be accrued for this study within 18 months.

OBJECTIVES: I. Determine the response of patients with refractory or progressive small cell or non-small cell lung cancer to FR901228.

II. Determine the ability of FR901228 to mediate apoptosis and target gene induction relative to tumor histology in these patients.

III. Determine the toxicity of this treatment in these patients.

PROTOCOL OUTLINE: Patients are stratified according to disease histology (small cell lung cancer vs non-small cell lung cancer).

Patients receive FR901228 IV over 4 hours on days 1 and 7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL:

A total of 18-43 patients (9-21 per arm) will be accrued for this study within 18 months.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2024 · 39 months · monthly snapshotCompleted~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Apr 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Jun 2000

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