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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-MC-JMHX | Other Identifier | Eli Lilly and Company |
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This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed | Experimental | Pemetrexed 500 mg/m^2 intravenous (IV) every 21 days for 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 milligrams per meter squared (mg/m^2) IV every 21 days for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overview of Adverse Events | Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | baseline, up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities | Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Tumor Response | Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions. PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions. SD (stable disease) = small changes that do not meet above criteria. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Copenhagen | 2100 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed | Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed | Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities | Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified. | Patients who received at least one dose of study drug. | Posted | Number | participants | baseline, up to 18 weeks |
|
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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 | Pemetrexed | Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008654 | Mesothelioma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| baseline, up to 18 weeks |
| Pemetrexed Population Pharmacokinetics (PK): Clearance | Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma. | Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion |
| Pemetrexed Population Pharmacokinetics: Volume of Distribution | Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment. | Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion |
| Discontinuations Due to Adverse Events | Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0. | baseline, up to 18 weeks |
| baseline, up to 18 weeks |
| Denmark |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hanover | 30625 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | 28041 | Spain |
| Withdrawal by Subject |
|
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Diagnosis of Non-Small Cell Lung Cancer (NSCLC) and mesothelioma were determined by each individual investigator. | Number | participants |
|
| Disease Stage | Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
|
| Fluid Severity | Mild = (1) pleural effusion detectable on radiological imaging, but less than moderate; (2) ascites detectable only by radiological imaging. Moderate = (1) pleural effusion less than 1/3 of the way up the thorax on 1 side on imaging and obscuring the entire hemidiaphragm on that side; (2) ascites detectable on physical exam (that is, fluid wave is palpable). Severe = (1) pleural effusion more than 1/3 of the way up the thorax on imaging; (2) ascites visibly detectable. For Moderate Fluid Severity, there were 13 patients with pleural effusion and 1 patient with ascites. | Number | participants |
|
| Primary Basis for Diagnosis | Number | participants |
|
| Type of Third-Space Fluid | Number | participants |
|
| Body Surface Area | Median | Full Range | meters squared (m^2) |
|
| Height | Median | Full Range | centimeters (cm) |
|
| Weight | Median | Full Range | kilograms (kg) |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Pemetrexed Population Pharmacokinetics (PK): Clearance | Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma. | Patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | milliliter per minute (mL/min) | Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion |
|
|
|
| Secondary | Pemetrexed Population Pharmacokinetics: Volume of Distribution | Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment. | Patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Liters (L) | Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion |
|
|
|
| Other Pre-specified | Overall Tumor Response | Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions. PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions. SD (stable disease) = small changes that do not meet above criteria. | Patients who received at least one dose of study drug. | Posted | Number | participants | baseline, up to 18 weeks |
|
|
|
| Secondary | Discontinuations Due to Adverse Events | Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0. | Patients who received at least one dose of study drug. | Posted | Number | participants | baseline, up to 18 weeks |
|
|
|
| Primary | Overview of Adverse Events | Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Patients who received at least one dose of study drug. | Posted | Number | participants | baseline, up to 18 weeks |
|
|
|
| 12 |
| 31 |
| 28 |
| 31 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pericardial excision | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Unknown |
|
|
| Respiratory failure (resulted in death) |
|
| Title | Measurements |
|---|---|
|
| SAE - Possibly related to study drug |
|
| Discontinuations Due to SAEs (including death) |
|
| Discontinuations - Possibly related to study drug |
|
| Discontinuations Due to Nonserious AEs |
|
| Deaths - On Study |
|
| Deaths - Possibly related to study drug |
|
| Deaths - Within 30 days of Study Discontinuation |
|