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NCT01361464 · ClinicalTrials.gov registry record · Phase 2

Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
21
Enrollment target

NCT01361464: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01361464 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01361464, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

This phase II trial is studying how well tipifarnib works in treating older patients with acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Complete Remission (CR) rate in Acute Myelogenous Leukemia (AML) patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. AML Complete Remission: Bone marrow aspiration - Less than 5% leukemic blasts, Auer rods not detected; Peripheral blood counts - Absolute neutrophil count \>/= 1,000/mm\^3, Platelet count \>/= 100,000/mm\^3, Leukemic blasts not present; Blood-product transfusion independence; Abs

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Tipifarnib

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2011-05
Est. Completion 2014-11
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01361464 record still lists

NCT01361464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01361464 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01361464 about?

NCT01361464 is a clinical study titled "Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia". This phase II trial is studying how well tipifarnib works in treating older patients with acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

What is the current status of trial NCT01361464?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2011-05. Estimated completion is 2014-11.

What interventions are being tested in trial NCT01361464?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Tipifarnib (DRUG).

Who is sponsoring clinical trial NCT01361464?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01361464's enrollment target sits among peer trials

21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01361464, the US trial registry maintained by the National Library of Medicine. NCT01361464 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.