Trial Outcomes & Findings for Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT01664897)
NCT ID: NCT01664897
Last Updated: 2020-01-07
Results Overview
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..
COMPLETED
PHASE2
29 participants
Up to 3 months post-treatment
2020-01-07
Participant Flow
Recruitment Period: May 2013 to May 2014
Participant milestones
| Measure |
Treatment (Erlotinib Hydrochloride)
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
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Erlotinib Hydrochloride)
n=29 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months post-treatmentOverall 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..
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=29 Participants
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
|
|---|---|
|
Participants With a Response
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysSafety summaries will include tabulations in the form of tables and listings. The number of participants affected by treatment-emergent adverse events will be reported.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=29 Participants
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
|
|---|---|
|
Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride
Fatigue
|
10 Participants
|
|
Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride
Diarrhea
|
10 Participants
|
|
Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride
Nausea
|
8 Participants
|
|
Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride
Rash
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 97 weeksTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=29 Participants
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
|
|---|---|
|
Overall Survival
|
14 Weeks
Interval 2.3 to 96.9
|
PRIMARY outcome
Timeframe: Up to 21 weeksTime from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Treatment (Erlotinib Hydrochloride)
n=29 Participants
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
|
|---|---|
|
Event-free Survival
|
5 Weeks
Interval 1.7 to 21.0
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: Samples and data required for the above outcome measure were not done, therefore we cannot report any outcomes for the above outcome measure.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Erlotinib Hydrochloride)
Serious adverse events
| Measure |
Treatment (Erlotinib Hydrochloride)
n=29 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic System disorder - other
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
General disorders
Death
|
10.3%
3/29 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
3/29 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Espohageal Ulcer
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
10.3%
3/29 • Number of events 3 • 1 year
|
|
General disorders
Fever
|
10.3%
3/29 • Number of events 3 • 1 year
|
|
Vascular disorders
Hematoma
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung Infection
|
31.0%
9/29 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Infections and infestations
Neutropenic Fever
|
17.2%
5/29 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Oral Mucositis
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
3.4%
1/29 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
10.3%
3/29 • Number of events 4 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Vascular disorders
Thromboembolic Event
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
3.4%
1/29 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Treatment (Erlotinib Hydrochloride)
n=29 participants at risk
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
|
|---|---|
|
Infections and infestations
Pneumonia
|
48.3%
14/29 • Number of events 14 • 1 year
|
|
Infections and infestations
Neutropenic Fever
|
44.8%
13/29 • Number of events 13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
37.9%
11/29 • Number of events 11 • 1 year
|
|
General disorders
Fatigue
|
34.5%
10/29 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
34.5%
10/29 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
27.6%
8/29 • Number of events 8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.1%
7/29 • Number of events 7 • 1 year
|
|
General disorders
Edema
|
17.2%
5/29 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
17.2%
5/29 • Number of events 5 • 1 year
|
|
Eye disorders
Watery eyes
|
17.2%
5/29 • Number of events 5 • 1 year
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Number of events 4 • 1 year
|
Additional Information
Jorge Cortes MD./Professor
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place