At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
Erlotinib Hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed AML
In Brief
A Phase 2 clinical trial evaluating Erlotinib Hydrochloride and Laboratory Biomarker Analysis for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and 10 related conditions. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Adult Acute Promyelocytic Leukemia With PML-RARA, Alkylating Agent-Related Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Astellas Pharma Inc
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartMay 2013
Primary CompletionOct 2018
TodayJul 2026
First PostedAug 14, 2012
Enrollment StartMay 16, 2013
Primary CompletionOct 25, 2018
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 13.9 years ago
Interventions
Erlotinib Hydrochloridedrug
Given PO
Laboratory Biomarker Analysisother
Correlative studies