Phase 2
Completed N=29
Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
leukemia · Chronic myelomonocytic leukemia · Myelodysplastic Syndromes · Previously Treated Myelodysplastic Syndrome
Source: ClinicalTrials.gov NCT01664897 ↗
Enrolled (actual)
29
Serious AEs
79.3%
Results posted
Jan 2020
Primary outcomePrimary: Participants With a Response — 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Response |
3 | — |
| PRIMARY Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride |
10; 10; 8; 7 | — |
| PRIMARY Overall Survival |
14 | — |
| PRIMARY Event-free Survival |
5 | — |
| SECONDARY Biomarker Expressions |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with AML who have either been refractory to prior therapy or have relapsed after prior therapy; patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who received therapy with a hypomethylating agent and progress to AML are eligible if they have received any therapy for MDS and failed (i.e., lack or loss of response) regardless of whether they have received therapy for AML or not; the World Health Organization (WHO) classification will be used for AML
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Total bilirubin =< 2 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) =< 2.5 x ULN
- Creatinine =< 2 x ULN
- Patients must provide written informed consent
- 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
- Patients-both males and females-with reproductive potential (i.e., menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to initiation of study
Exclusion Criteria
- Patients with known allergy or hypersensitivity to erlotinib
- 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 unwilling or unable to comply with the protocol
- Significant gastrointestinal disorders that may interfere with absorption of erlotinib
- Patients who can receive a stem cell transplant within 4 weeks
Data sourced from ClinicalTrials.gov (NCT01664897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.