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AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance |
|
| II | Experimental | Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance |
|
| III | Active Comparator | pemetrexed and cisplatin |
|
| IV | Experimental | Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance |
|
| V | Active Comparator | pemetrexed and cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| axitinib | Drug | 5mg BID po up to max 10mg BID po |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was "Death") or from the end of study data. | Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Huntsville | Alabama | 35805 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24766732 | Derived | Belani CP, Yamamoto N, Bondarenko IM, Poltoratskiy A, Novello S, Tang J, Bycott P, Niethammer AG, Ingrosso A, Kim S, Scagliotti GV. Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. BMC Cancer. 2014 Apr 25;14:290. doi: 10.1186/1471-2407-14-290. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Axitinib + Pemetrexed/Cisplatin (Phase 1) | Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
|
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| axitinib | Drug | 5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy |
|
|
| chemotherapy | Drug | Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles |
|
|
| axitinib | Drug | 5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy |
|
| chemotherapy | Drug | Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles |
|
|
| Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions. | Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks |
| Duration of Response (DR) | Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks |
| Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score | Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. | Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT) |
| Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score | Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. | Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT |
| Atlanta |
| Georgia |
| 30341 |
| United States |
| Pfizer Investigational Site | Decatur | Georgia | 30033 | United States |
| Pfizer Investigational Site | Macon | Georgia | 31217 | United States |
| Pfizer Investigational Site | Marietta | Georgia | 30060 | United States |
| Pfizer Investigational Site | Sandy Springs | Georgia | 30342 | United States |
| Pfizer Investigational Site | Bloomington | Illinois | 61701 | United States |
| Pfizer Investigational Site | Peoria | Illinois | 61615 | United States |
| Pfizer Investigational Site | Hershey | Pennsylvania | 17033-0850 | United States |
| Pfizer Investigational Site | West Reading | Pennsylvania | 19611 | United States |
| Pfizer Investigational Site | East Providence | Rhode Island | 02914 | United States |
| Pfizer Investigational Site | East Providence | Rhode Island | 02915 | United States |
| Pfizer Investigational Site | Genova | 16132 | Italy |
| Pfizer Investigational Site | Lido Di Camaiore (LU) | 55043 | Italy |
| Pfizer Investigational Site | Orbassano (TO) | 10043 | Italy |
| Pfizer Investigational Site | Sunto-gun | Shizuoka | Japan |
| Pfizer Investigational Site | Lubin | 59-300 | Poland |
| Pfizer Investigational Site | Otwock | 05-400 | Poland |
| Pfizer Investigational Site | Piła | 64-920 | Poland |
| Pfizer Investigational Site | Poznan | 60-569 | Poland |
| Pfizer Investigational Site | Poznan | 61-485 | Poland |
| Pfizer Investigational Site | Prabuty | 82-550 | Poland |
| Pfizer Investigational Site | Warsaw | 00-909 | Poland |
| Pfizer Investigational Site | Bacau | Bacău | 600114 | Romania |
| Pfizer Investigational Site | Iași | Iaşi | 700106 | Romania |
| Pfizer Investigational Site | Moscow | 115478 | Russia |
| Pfizer Investigational Site | Pyatigorsk | 357502 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194044 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 197089 | Russia |
| Pfizer Investigational Site | Terrassa | Barcelona | 08221 | Spain |
| Pfizer Investigational Site | Castellon | Castellon | 12002 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28007 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28041 | Spain |
| Pfizer Investigational Site | Palma de Mallorca | Palma de Mallorca | 07010 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41009 | Spain |
| Pfizer Investigational Site | Basel | CH-4016 | Switzerland |
| Pfizer Investigational Site | Basel | CH-4031 | Switzerland |
| Pfizer Investigational Site | Bruderholz | CH-4101 | Switzerland |
| Pfizer Investigational Site | Liestal | CH-4410 | Switzerland |
| Pfizer Investigational Site | Taichung | 402 | Taiwan |
| Pfizer Investigational Site | Taichung | 40705 | Taiwan |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| Pfizer Investigational Site | Taipei | 112 | Taiwan |
| Pfizer Investigational Site | Dnipropetrovsk | 49102 | Ukraine |
| Pfizer Investigational Site | Kyiv | 03115 | Ukraine |
| Pfizer Investigational Site | Romford | Essex | RM7 0AG | United Kingdom |
| Pfizer Investigational Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Pfizer Investigational Site | Bournemouth | BH7 7DW | United Kingdom |
| Pfizer Investigational Site | Brighton | BN2 5BE | United Kingdom |
| Pfizer Investigational Site | Dundee | DD1 9SY | United Kingdom |
| Pfizer Investigational Site | Middlesex | HA6 2RN | United Kingdom |
| Pfizer Investigational Site | Poole | BH15 2JB | United Kingdom |
| FG001 | Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2) | Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| FG002 | Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2) | Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| FG003 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Axitinib + Pemetrexed/Cisplatin (Phase 1) | Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal. |
| BG001 | Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2) | Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| BG002 | Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2) | Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| BG003 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| BG004 | 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Progression-Free Survival (PFS) | Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was "Death") or from the end of study data. | Full analysis (FA) population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks |
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| Secondary | Overall Survival (OS) | Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). | FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant |
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| Secondary | Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions. | FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks |
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| Secondary | Duration of Response (DR) | Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Subgroup of participants from the FA population with a confirmed objective tumor response (CR or PR). | Posted | Median | 95% Confidence Interval | months | Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks |
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| Secondary | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score | Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. | FA population; 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' is number of participants analyzed at specific time point for each treatment arm respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT) |
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| Secondary | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score | Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. | FA population; 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' is number of participants analyzed at specific time point for each treatment arm respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Axitinib + Pemetrexed/Cisplatin (Phase 1) | Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal. | 1 | 10 | 10 | 10 | ||
| EG001 | Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2) | Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. | 19 | 55 | 54 | 55 | ||
| EG002 | Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2) | Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. | 20 | 58 | 56 | 58 | ||
| EG003 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. | 13 | 55 | 54 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Small intestine ulcer | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Basal ganglia infarction | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aerophagia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mucous membrane disorder | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood creatinine | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemoglobin | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypophonesis | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Transaminases | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| White blood cell count | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Expressive language disorder | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077784 | Axitinib |
| D004358 | Drug Therapy |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013812 | Therapeutics |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| Study Terminated by Sponsor |
|
| Randomized but not treated |
|
| Greater Than or Equal to 65 Years |
|
| Male |
|
| P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above. | Log Rank | One-sided log-rank test at alpha = 0.20 significance level was used. | 0.3565 | Hazard Ratio (HR) | 0.947 | 2-Sided | 95 | 0.580 | 1.546 | No | Superiority or Other |
| OG002 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
|
|
|
| OG001 | Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2) | Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| OG002 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
|
|
|
| OG002 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
|
|
| Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2) |
Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| OG002 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
|
|
Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
| OG002 | Pemetrexed/Cisplatin (Phase 2) | Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal. |
|
|