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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-IT-S105 |
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Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed - Before Protocol Amendment | Experimental |
| |
| Pemetrexed - After Protocol Amendment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed - Before Protocol Amendment | Drug | 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH). | pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) |
| Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH). | pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Objective Tumor Response | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to measured response (every 14 days for 6 cycles) |
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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. | Milan | Italy |
Of the 19 enrolled patients, 12 were enrolled before the protocol amendment was made effective (i.e. 2-weekly administration) and 7 were enrolled after the amendment (i.e. 3-weekly administration).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed | 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pemetrexed - After Protocol Amendment | Drug | 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue. |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed - Before Amendment | 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue. |
| BG001 | Pemetrexed - After Amendment | 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Disease Stages | Stage means how big the tumor is and how far it's spread. Stages range from 0 (tumor has not spread) to IV (tumor has spread to other organs). | Number | participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
| |||||||||||||||
| Histopathological Grade | Assesses the extent to which cancer cells are similar in appearance and function to healthy cells of the same tissue type. Grades range from 1 (least aggressive and best prognosis) to 4 (most aggressive and worst prognosis). | Number | participants |
| |||||||||||||||
| Previous Anti-Tumor Treatment | Number | participants |
| ||||||||||||||||
| Previous Surgery | Participants having surgery could have more than one type of surgery. | Number | participants |
| |||||||||||||||
| Race/Ethnicity | Number | participants |
| ||||||||||||||||
| Tumor Type | Number | participants |
| ||||||||||||||||
| Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Body Surface Area (BSA) | BSA = 0.007184 x weight(kg)^0.425 x height(cm)^0.725 | Mean | Standard Deviation | square meters (m^2) |
| ||||||||||||||
| Body Temperature | Mean | Standard Deviation | degrees Celsius (°C) |
| |||||||||||||||
| Heart Rate | Mean | Standard Deviation | beats per minute (bpm) |
| |||||||||||||||
| Height | One participant in the Pemetrexed - Before Amendment group was missing a baseline height measurement. | Mean | Standard Deviation | centimeters (cm) |
| ||||||||||||||
| Weight | One participant in the Pemetrexed - Before Amendment group was missing a baseline weight measurement. | Mean | Standard Deviation | kilograms (kg) |
|
| 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 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH). | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | mRNA relative values (ratio with GAPDH) | pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Objective Tumor Response | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | Number of participants who received at least one dose of study drug. | Posted | Number | participants | baseline to measured response (every 14 days for 6 cycles) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH). | Number of participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | mRNA relative values (ratio with GAPDH) | pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) |
|
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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 | 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue. | 5 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Petechiae | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Omphalitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Transaminases | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Balanitis | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Epistaxis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 10.1 | 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 |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | 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 |
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| Male |
|
| Stage IA |
|
| Stage IB |
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| Stage IIA |
|
| Stage IIB |
|
| Stage IIIA |
|
| Stage IIIB |
|
| Stage IV |
|
| 1 - Ambulatory, Restricted Strenuous Activity |
|
| 2 - Ambulatory, No Work Activities |
|
| G1 - Well-Differentiated |
|
| G2 - Moderately Differentiated |
|
| G3 - Poorly Differentiated |
|
| Yes |
|
| Surgery - Yes: Pneumonectomy |
|
| Surgery - Yes: Lobectomy |
|
| Surgery - Yes: Other |
|
| Surgery - Yes: Radical |
|
| Squamous Cell Carcinoma |
|
| Other |
|
| Diastolic Blood Pressure (DBP) |
|
|
| 2 Hours Post-Dose |
|
| 4 Hours Post-Dose |
|
| 6 Hours Post-Dose |
|
| 24 Hours Post-Dose |
|
| 48 Hours Post-Dose |
|
| <0.001 |
P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles). |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures Analysis of Variance | 0.030 | P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles). | 95 | No | Superiority or Other |
| Repeated Measures Analysis of Variance | 0.166 | P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles). | 95 | No | Superiority or Other |
| Repeated Measures Analysis of Variance | <0.001 | P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles). | 95 | No | Superiority or Other |
| Repeated Measures Analysis of Variance | <0.001 | P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles). | 95 | No | Superiority or Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|