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The purpose of this trial is: - To characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with CP and panitumumab.
This was a multicenter, open-label, dose-finding clinical trial examining the safety and PK of once or twice daily motesanib administered with CP or with CP and panitumumab in chemotherapy naïve patients, and with panitumumab in patients with no more than one prior chemotherapy regimen for NSCLC.
Participants were enrolled into the Panitumumab + Paclitaxel + Carboplatin + Motesanib once a safe and tolerable dose of AMG 706 was established in the other treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel + Carboplatin + Motesanib | Experimental | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. The initial dose of motesanib was 50 mg once daily administered in the initial cohort and up to 125 mg once daily was used in subsequent cohorts. A cycle was defined as the 3 weeks plus the time to recover from toxicity, if encountered. |
|
| Panitumumab + Motesanib | Experimental | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab administered by IV at 9.0 mg/kg on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. The initial dose of motesanib was 50 mg once daily administered in the initial cohort, up to 125 mg once daily was used in subsequent cohorts. |
|
| Panitumumab + Paclitaxel + Carboplatin + Motesanib | Experimental | Chemotherapy naïve participants received panitumumab administered by IV at 9.0 mg/kg on Day 1 of each 21-day cycle, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. Participants were enrolled in this arm once a safe and tolerable dose of motesanib was established. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Biological | 9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1 | The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose. | Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
| Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1 | The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose. | Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
| Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1 | The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose. | Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose. |
| Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1 | Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose. | Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
| Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Overall Objective Response | Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20028752 | Background | Blumenschein GR Jr, Reckamp K, Stephenson GJ, O'Rourke T, Gladish G, McGreivy J, Sun YN, Ye Y, Parson M, Sandler A. Phase 1b study of motesanib, an oral angiogenesis inhibitor, in combination with carboplatin/paclitaxel and/or panitumumab for the treatment of advanced non-small cell lung cancer. Clin Cancer Res. 2010 Jan 1;16(1):279-90. doi: 10.1158/1078-0432.CCR-09-1675. Epub 2009 Dec 22. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 18 January 2005 through 25 September 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel/Carboplatin + Motesanib 50 mg QD | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Motesanib diphosphate | Drug | Dose-finding with an initial dose of 50 mg once daily and up to 125 mg once daily. 75 mg twice daily was also to be tested. |
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| Paclitaxel | Drug | Paclitaxel 200 mg/m^2 administered by IV infusion over 3 hours. |
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| Carboplatin | Drug | Carboplatin was administered IV over approximately 30 minutes. Carboplatin was dosed using the glomerular filtration rate (GFR) and Calvert formula to AUC/time curve of 6 mg/mL×min. |
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The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose). |
| Cycle 1, Day 3, 24 hours post-dose |
| Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2 | The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose. | Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
| Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2 | The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose. | Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
| Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2 | The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose. | Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
| Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2 | Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose. | Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
| Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2 | The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose). | Cycle 2, Day 1, 24 hours post-dose |
| After 9 weeks of treatment (at the end of Cycle 3) |
| FG001 |
| Paclitaxel/Carboplatin + Motesanib 125 mg QD |
Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| FG002 | Paclitaxel/Carboplatin + Motesanib 75 mg BID | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| FG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| FG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| FG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| FG006 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| Treated With Motesanib |
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| COMPLETED |
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| NOT COMPLETED |
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The analysis is based on the Safety Analysis Set which consists of all consented participants who received at least one dose of motesanib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel/Carboplatin + Motesanib 50 mg QD | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| BG001 | Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| BG002 | Paclitaxel/Carboplatin + Motesanib 75 mg BID | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| BG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| BG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| BG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| BG006 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||
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| Primary | Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1 | The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose. | The pharmacokinetic (PK) population consisted of all consented patients who received motesanib and had evaluable pharmacokinetic data and did not have significant protocol deviations that affected the data or key-dosing information that was missing. | Posted | Median | Full Range | hours | Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
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| Secondary | Percentage of Participants With an Overall Objective Response | Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions. | Efficacy analysis set, composed of all enrolled participants who received at least one dose of motesanib in treatment arms 1-3 or at least one dose of motesanib with one dose of panitumumab in treatmnt arms 4-7. | Posted | Number | Percentage of participants | After 9 weeks of treatment (at the end of Cycle 3) |
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| Primary | Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1 | The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose. | PK population | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
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| Primary | Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1 | The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose. | PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3. | Posted | Mean | Standard Deviation | hours | Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose. |
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| Primary | Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1 | Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose. | PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3. | Posted | Mean | Standard Deviation | μg*hr/mL | Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
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| Primary | Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1 | The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose). | PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Day 3, 24 hours post-dose |
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| Primary | Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2 | The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose. | PK population | Posted | Median | Full Range | hours | Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
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| Primary | Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2 | The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose. | PK population | Posted | Mean | Standard Deviation | ng/mL | Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
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| Primary | Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2 | The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose. | PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for three treatment groups for which the sample size was smaller than 3. | Posted | Mean | Standard Deviation | hours | Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
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| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2 | Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose. | PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3. | Posted | Mean | Standard Deviation | μg*hr/mL | Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose. |
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| Primary | Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2 | The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose). | PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3. | Posted | Mean | Standard Deviation | ng/mL | Cycle 2, Day 1, 24 hours post-dose |
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First dose through 30 days after last dose; maximum time on treatment was 322 days.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
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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 | Paclitaxel/Carboplatin + Motesanib 50 mg QD | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. | 5 | 6 | 6 | 6 | ||
| EG001 | Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. | 2 | 11 | 11 | 11 | ||
| EG002 | Paclitaxel/Carboplatin + Motesanib 75 mg BID | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. | 3 | 6 | 6 | 6 | ||
| EG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. | 0 | 4 | 4 | 4 | ||
| EG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. | 1 | 7 | 7 | 7 | ||
| EG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. | 4 | 5 | 5 | 5 | ||
| EG006 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. | 2 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 9.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Change of bowel habit | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Gingival ulceration | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pelvic discomfort | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pleural rub | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| C000625785 | motesanib diphosphate |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| OG001 | Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG002 | Paclitaxel/Carboplatin + Motesanib 75 mg BID | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG006 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
|
|
| OG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG006 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
|
|
| OG002 | Paclitaxel/Carboplatin + Motesanib 75 mg BID | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
|
|
| OG002 | Paclitaxel/Carboplatin + Motesanib 75 mg BID | Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
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| OG002 |
| Paclitaxel/Carboplatin + Motesanib 75 mg BID |
Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
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| OG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG006 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
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| OG003 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG005 | Panitumumab + Motesanib 75 mg BID | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG006 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
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| OG002 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG003 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
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| OG002 | Panitumumab + Motesanib 50 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG003 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
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| Panitumumab + Motesanib 50 mg QD |
Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG003 | Panitumumab + Motesanib 125 mg QD | Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
| OG004 | Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD | Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. |
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