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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-7017+Carboplatin/Paclitaxel | Experimental | Drug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL*min, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m^2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-7017 | Drug | Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4~6 cycles (1 cycle: 3 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D). | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose |
| Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose |
| Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose |
| Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | The best overall response is the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD], and progressive disease [PD]) among all overall responses from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, [confirmed and unconfirmed, (CR + PR) / number of participants]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Gangnam-gu | 135-710 | South Korea |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
This dose-escalating study included an initial and additional portion. Participants received CS-7017 combination treatment with carboplatin & paclitaxel (starting dose 0.25 mg twice daily [BID] in the initial portion). In the additional portion, the CS-7017 dose was determined (0.50 mg BID) based on the initial portion.
A total of 18 participants were screened for eligibility. Of the 18 participants who were screened, 16 participants who met all inclusion criteria and no exclusion criteria were enrolled from 17 March 2010 to 15 April 2011 at 1 site in South Korea. All 16 participants received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | CS-7017 0.25 mg BID; Initial Portion | Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. |
| FG001 | CS-7017 0.50 mg BID; Initial Portion | Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. |
| FG002 | CS-7017 0.50 mg BID; Additional Portion | Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline demographic characteristics were assessed in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | CS-7017 0.25 mg BID; Initial Portion | Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D). | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng*h/mL | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose |
|
Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year.
Adverse events were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within the 30 days after the last dose of the study drug.
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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 | CS-7017 0.25 mg BID; Initial Portion | Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D013899 | Thoracic Neoplasms |
Not provided
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| ID | Term |
|---|---|
| C510342 | efatutazone |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
Not provided
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| Carboplatin | Drug | Drug: Carboplatin IV, AUC of 6 mg/mL*min, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) |
|
|
| Paclitaxel | Drug | Drug: Paclitaxel IV, 200mg/m^2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) |
|
|
Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. |
| Baseline to end of Cycle 1, with each treatment cycle being 3 weeks |
| Baseline up to Week 18 postdose |
| CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship. | Baseline to 30 days after last dose, up to approximately 1 year |
| Progressive disease |
|
| Withdrawal by Subject |
|
| BG001 | CS-7017 0.50 mg BID; Initial Portion | Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. |
| BG002 | CS-7017 0.50 mg BID; Additional Portion | Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min.
| OG001 | CS-7017 0.50 mg BID; Initial Portion | Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. |
| OG002 | CS-7017 0.50 mg BID; Additional Portion | Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel |
|
|
| Primary | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose |
|
|
|
| Primary | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Median | Full Range | h | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose |
|
|
|
| Primary | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. | TEAEs were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline to end of Cycle 1, with each treatment cycle being 3 weeks |
|
|
|
| Secondary | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | The best overall response is the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD], and progressive disease [PD]) among all overall responses from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, [confirmed and unconfirmed, (CR + PR) / number of participants]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Best overall response and objective response rate were assessed in the Efficacy Analysis Set. | Posted | Count of Participants | Participants | Baseline up to Week 18 postdose |
|
|
|
| Secondary | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship. | CS-7017-related TEAEs were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline to 30 days after last dose, up to approximately 1 year |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | CS-7017 0.50 mg BID; Initial Portion | Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. | 1 | 4 | 1 | 4 | 4 | 4 |
| EG002 | CS-7017 0.50 mg BID; Additional Portion | Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL*min. Cycle 1, Day 1: Carboplatin and paclitaxel only Cycle 1, Day 3: CS-7017 at the dose selected in initial portion Subsequent cycles: CS-7017 with carboplatin and paclitaxel | 0 | 9 | 6 | 9 | 9 | 9 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
Not provided
Not provided
| D009371 |
| Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Cycle 2, Week 4: Cmax,ss |
|
|
| Cycle 2, Week 4: Tmax,ss |
|
|
|
| Neutropenia |
|
| Anaemia |
|
| Metabolism and Nutrition Disorders |
|
| Decreased appetite |
|
| Nervous System Disorders |
|
| Neuropathy peripheral |
|
| Respiratory, Thoracic and Mediastinal Disorders |
|
| Pleural effusion |
|
| Gastrointestinal Disorders |
|
| Nausea |
|
| Skin and Subcutaneous Tissue Disorders |
|
| Alopecia |
|
| Pruritus |
|
| Musculoskeletal and Connective Tissue Disorders |
|
| Myalgia |
|
| Athralgia |
|
| General Disorders & Administration Site Conditions |
|
| Fatigue |
|
| Investigations |
|
| Weight increased |
|
| Partial response (PR) |
|
| Stable disease (SD) |
|
| Progressive disease (PD) |
|
| Not evaluable (NE) |
|
| Missing |
|
| Response rate (CR + PR) |
|
|
| Pleural effusion |
|
| General Disorders & Administration Site Conditions |
|
| Face oedema |
|
| Oedema peripheral |
|
| Investigations |
|
| Weight increased |
|