TriangleNCT01664897 · STUDY IN CONTEXT
Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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 is all CR criteria if abnormal prior to treatment except \>/= 50%reduction in bone marrow blast but still \> 5%. MLF is \</=5% myeloblasts on bone marrow . HI response must be described by the number of positively affected cell lines..
Safety summaries will include tabulations in the form of tables and listings. The number of participants affected by treatment-emergent adverse events will be reported.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Descriptive statistics will be used to summarize the expression of biomarkers and the concentrations of plasma erlotinib hydrochloride. The Wilcoxon rank sum test will be used to compare the expressions of biomarkers and concentrations of plasma erlotinib hydrochloride between patients with and without response.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- trial label
- Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0000
- source section id
- NCT01664897-om-0000
- source outcome index
- 0
- endpoint
- Participants With a Response
- endpoint definition
- 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 is all CR criteria if abnormal prior to treatment except \>/= 50%reduction in bone marrow blast but still \> 5%. MLF is \</=5% myeloblasts on bone marrow . HI response must be described by the number of positively affected cell lines..
- time origin
- Up to 3 months post-treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0001
- source section id
- NCT01664897-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride
- endpoint definition
- Safety summaries will include tabulations in the form of tables and listings. The number of participants affected by treatment-emergent adverse events will be reported.
- time origin
- Up to 30 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0002
- source section id
- NCT01664897-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Time from date of treatment start until date of death due to any cause or last Follow-up.
- time origin
- Up to 97 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0003
- source section id
- NCT01664897-om-0003
- source outcome index
- 3
- endpoint
- Event-free Survival
- endpoint definition
- Time from date of treatment start until the date of first objective documentation of disease-relapse.
- time origin
- Up to 21 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0004
- source section id
- NCT01664897-om-0004
- source outcome index
- 4
- endpoint
- Biomarker Expressions
- endpoint definition
- Descriptive statistics will be used to summarize the expression of biomarkers and the concentrations of plasma erlotinib hydrochloride. The Wilcoxon rank sum test will be used to compare the expressions of biomarkers and concentrations of plasma erlotinib hydrochloride between patients with and without response.
- time origin
- Up to 30 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Samples and data required for the above outcome measure were not done, therefore we cannot report any outcomes for the above outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Erlotinib Hydrochloride)
- regimen
- Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01664897-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Erlotinib Hydrochloride)
- regimen
- Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01664897-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Erlotinib Hydrochloride)
- regimen
- Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01664897-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Erlotinib Hydrochloride)
- regimen
- Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01664897-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Erlotinib Hydrochloride)
- regimen
- Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01664897-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chemotherapy-related-leukemia
- nct id
- NCT01664897
- harm key
- EG000
- source section id
- NCT01664897-ae
- event group key
- EG000
- event group label
- Treatment (Erlotinib Hydrochloride)
- serious affected
- 23
- serious at risk
- 29
- other affected
- 29
- other at risk
- 29
- frequency threshold
- 5
- collection period
- 1 year
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice