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NCT01664897 · ClinicalTrials.gov registry record · Phase 2

Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT01664897: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01664897 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01664897, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

This pilot phase II trial studies how well erlotinib hydrochloride works in treating patients with relapsed or refractory acute myeloid leukemia. Erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Overall Response is complete remission (CR) + CR with incomplete hematologic recovery (CRi) + Partial remission (PR) + Hematologic improvement (HI) + Morphologic Leukemia-Free State (MLF). (CR) is Bone marrow; \</=5% blasts, no Auer rods or extramedullary disease and peripheral blood counts \>/= 1.0x10\^9/L Neutrophils, \>/= 100x10\^9/L platelets and no circulating blasts. (CRi), same as CR for bone marrow and \<1.0x10\^9/L neutrophils and \< 100x10\^9/L platelets in peripheral blood counts. PR

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Erlotinib Hydrochloride

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2013-05-16
Est. Completion 2018-10-25
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01664897 record still lists

NCT01664897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

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

NCT01664897 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01664897 about?

NCT01664897 is a clinical study titled "Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This pilot phase II trial studies how well erlotinib hydrochloride works in treating patients with relapsed or refractory acute myeloid leukemia. Erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

What is the current status of trial NCT01664897?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2013-05-16. Estimated completion is 2018-10-25.

What interventions are being tested in trial NCT01664897?

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

Who is sponsoring clinical trial NCT01664897?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01664897's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 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 NCT01664897, the US trial registry maintained by the National Library of Medicine. NCT01664897 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.