Completed

A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed AML

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What is being tested

Erlotinib Hydrochloride

+ Laboratory Biomarker Analysis

DrugOther
Who is being recruted

Bone Marrow Diseases+14

+ Chronic Disease

+ Hematologic Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 7, 2020
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Study start date: May 16, 2013

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To assess the efficacy of erlotinib (erlotinib hydrochloride) in patients with refractory or relapsed acute myeloid leukemia (AML). II. To determine the safety and tolerability of erlotinib in this patient population. SECONDARY OBJECTIVES: I. To investigate inhibitory effect of this drug on spleen tyrosine kinase (SYK) and its down-stream targets such as mitogen-activated protein kinase 8 (JNK), mitogen-activated protein kinase (MAPK) and mitogen-activated protein kinase 1 (Erk). II. To evaluate its role in janus kinase (Jak)/signal transducer and activator of transcription (STAT) pathway and to investigate erlotinib-mediated cell death and/or differentiation. III. To quantitate concentrations of plasma erlotinib. OUTLINE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

NCT01664897
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 7, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesMyelodysplastic-Myeloproliferative DiseasesMyelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Promyelocytic, AcuteLeukemia, Myelomonocytic, ChronicLeukemia, Myelomonocytic, Acute

Criteria

8 inclusion criteria required to participate
Alanine aminotransferase (ALT) = < 2.5 x ULN
Creatinine = < 2 x ULN
Eastern Cooperative Oncology Group (ECOG) performance status = < 2
Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the clinically significant toxic effects of that therapy to at least grade 1; use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy
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5 exclusion criteria prevent from participating
Patients unwilling or unable to comply with the protocol
Patients who can receive a stem cell transplant within 4 weeks
Patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association [NYHA] class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Patients with known allergy or hypersensitivity to erlotinib
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

M D Anderson Cancer Center

Houston, United StatesOpen M D Anderson Cancer Center in Google Maps
CompletedOne Study Center