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| Name | Class |
|---|---|
| OSI Pharmaceuticals | INDUSTRY |
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This research study is looking for patients with newly diagnosed acute myeloid leukemia (AML), AML that has returned (relapsed), or it has not responded adequately to previous treatments. Treating certain patients with chemotherapy may not be to their benefit or may cause more harm than benefit. The purpose of this study is to find out what effects (good and bad) erlotinib has on patients and their AML.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib | The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated. | 3 months of treatment with erlotinib |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission | The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. | 1 year after treatment discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts | Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S. Hamid Sayar, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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This protocol was based on getting 14 patients. Due to the lack of response, the study was stopped at 11 patients for this pilot study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib | The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated. | All patients enrolled and received treatment | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months of treatment with erlotinib |
|
Up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLOOD/BONE MARROW - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hamid Sayar | IndianaU | (317)278-6871 | ssayar@iu.edu |
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| ID | Term |
|---|---|
| D015479 | Leukemia, Myelomonocytic, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Treatment Related Adverse Events Grade 3 or Higher | Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater. | up to 15 months |
| Withdrawal by Subject |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission | The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. | All patients enrolled and received treatment | Posted | Mean | Standard Deviation | months | 1 year after treatment discontinuation |
|
|
|
| Secondary | Treatment Related Adverse Events Grade 3 or Higher | Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater. | Posted | Number | participants | up to 15 months |
|
|
|
| Other Pre-specified | Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts | Not Posted | Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12 | Participants |
| 5 |
| 11 |
| 10 |
| 11 |
|
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEPATOBILIARY/PANCREAS - OTHER | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CREATININE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| SODIUM, SERUM-LOW (HYPONATREMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| URIC ACID, SERUM-HIGH (HYPERURICEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC ARRHYTHMIA - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC GENERAL - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - CARDIAC/HEART | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VISION-BLURRED VISION | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DRY MOUTH/SALIVARY GLAND (XEROSTOMIA) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA: LIMB | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - OTHER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGORS/CHILLS | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SWEATING (DIAPHORESIS) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALLERGY/IMMUNOLOGY - OTHER | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA) | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| METABOLIC/LABORATORY - OTHER | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| PLATELETS | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| WEIGHT LOSS | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CALCIUM, SERUM-LOW (HYPOCALCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - WHOLE BODY/GENERALIZED | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCULOSKELETAL/SOFT TISSUE - OTHER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BACK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - JOINT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - NECK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD ALTERATION - AGITATION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD ALTERATION - ANXIETY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROLOGY - OTHER | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - HEAD/HEADACHE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RENAL/GENITOURINARY - OTHER | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BRONCHOSPASM, WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DERMATOLOGY/SKIN - OTHER | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |