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This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG-013736/Cisplatin/Gemcitabine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-013736 | Drug | AG-013736 5 mg tablets orally, twice daily, until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. | Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Baseline until death or assessed every 2 months (up to 28 days after the last dose) |
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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 | Torun | 87-100 | Poland | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25929582 | Derived | Bondarenko IM, Ingrosso A, Bycott P, Kim S, Cebotaru CL. Phase II study of axitinib with doublet chemotherapy in patients with advanced squamous non-small-cell lung cancer. BMC Cancer. 2015 May 1;15:339. doi: 10.1186/s12885-015-1350-6. |
| 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 + Cisplatin + Gemcitabine | Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| gemcitabine | Drug | 200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles |
|
| cisplatin | Drug | 1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles |
|
| Progression Free Survival (PFS) | Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). | Baseline, assessed every 2 months (up to 28 days after the last dose) |
| 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. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer 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. | Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) |
| Wodzislaw Sl. |
| 44-300 |
| Poland |
| Pfizer Investigational Site | Cluj-Napoca | Cluj | 400015 | Romania |
| Pfizer Investigational Site | Bucharest | 022328 | Romania |
| Pfizer Investigational Site | Oradea | 410032 | Romania |
| Pfizer Investigational Site | Parktown | 2193 | South Africa |
| Pfizer Investigational Site | Dnipropetrovsk | 49102 | Ukraine |
| Pfizer Investigational Site | Donetsk | 83092 | Ukraine |
| Pfizer Investigational Site | Kyiv | 04107 | Ukraine |
| Pfizer Investigational Site | Lviv | 79031 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Axitinib + Cisplatin + Gemcitabine | Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase. |
| 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 |
|
| 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 | Percentage of Participants With Objective Response (OR) | Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. | Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) |
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| Secondary | Overall Survival (OS) | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Baseline until death or assessed every 2 months (up to 28 days after the last dose) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). | ITT population included all enrolled participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Baseline, assessed every 2 months (up to 28 days after the last dose) |
|
| ||||||||||||||||||||||||||
| 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. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer 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. | DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR). | Posted | Median | 95% Confidence Interval | Months | Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) |
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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 + Cisplatin + Gemcitabine | Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase. | 15 | 38 | 34 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Lung abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary artery thrombosis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
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| Creatinine renal clearance decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Nephropathy toxic | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Pulmonary cavitation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
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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 |
|---|---|
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077784 | Axitinib |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Participants |
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