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This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E7090 Arm | Experimental | Oral, starting dose 1 mg once a day, dose escalation in part 1. Cycle 0 is for 7 days. For Cycle 1 and onward, each cycle is 28 days long. The Cycle 0 is set up for PK analysis of a single dose of E7090. In the following Cycle 1, subjects will be administered E7090 QD, and the PK and safety will be assessed for 28 days. One or two doses may be selected from part 1 for Part 2. E7090 will be administered continuously once a daily. Subjects can continue treatment unless they meet discontinuation criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7090 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade >=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (>) 7 milligram per deciliter (mg/dL) persisting for >=7 days despite best treatment, serum phosphate level >9 mg/dL despite best treatment; f. treatment interruption for >=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for >=8 days for reasons other than toxicity. | Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. | From the start of study drug administration up to 2 year 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Overall Survival (OS) | OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method. | From the date of first dose of study drug up to 2 years and 8 months |
| Part 2: Progression- Free Survival (PFS) |
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Inclusion Criteria: Part 1and Part 2
Provide written informed consent
Male or female subjects age >= 20 years at the time of informed consent
Subjects with a histological and/or cytological diagnosis of solid tumor
Subjects who failed standard therapies, or for which no appropriate treatment is available.
Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
Inclusion Criteria: Part 2 only
Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #1 | Nagoya | Aichi-ken | Japan | |||
| Eisai Trial Site #1 |
A total of 40 participants were enrolled in this study. This study consisted of two parts: Part 1 and Part 2. In Part 1, 24 participants were enrolled and received study treatment and in Part 2, 16 participants were enrolled and received the study treatment.
Participants took part in the study at 18 investigative sites in Japan from 28 October 2014 to 03 September 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: E7090 1 mg With Solid Tumor | Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG001 | Part 1: E7090 2 mg With Solid Tumor | Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG002 | Part 1: E7090 4 mg With Solid Tumor | Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG003 | Part 1: E7090 8 mg With Solid Tumor | Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG004 | Part 1: E7090 16 mg With Solid Tumor | Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG005 | Part 1: E7090 30 mg With Solid Tumor | Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG006 | Part 1: E7090 60 mg With Solid Tumor | Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG007 | Part 1: E7090 100 mg With Solid Tumor | Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG008 | Part 1: E7090 140 mg With Solid Tumor | Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG009 | Part 1: E7090 180 mg With Solid Tumor | Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG010 | Part 2: E7090 140 mg With Gastric Cancer | Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| FG011 | Part 2: E7090 140 mg With Cholangiocarcinoma | Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set was the group of participants who received at least 1 dose of E7090.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: E7090 1 mg With Solid Tumor | Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade >=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (>) 7 milligram per deciliter (mg/dL) persisting for >=7 days despite best treatment, serum phosphate level >9 mg/dL despite best treatment; f. treatment interruption for >=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for >=8 days for reasons other than toxicity. | The DLT analysis set was the group of participants in the Part 1 who completed Cycle 0 and Cycle 1 treatment of E7090 with at least 75% compliance and were evaluated for DLT, and those who developed DLT during Cycle 0 or Cycle 1. This outcome measure was planned to be analyzed for Part 1 only. | Posted | Count of Participants | Participants | Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days) |
From the start of study drug administration up to 2 year and 9 months
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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 | Part 1: E7090 1 mg With Solid Tumor | Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA version 24.0. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inquiry Service. | Eisai Co., Ltd. | eisai-chiken_hotline@hhc.eisai.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2018 | Nov 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2021 | Sep 12, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method. |
| From the date of first dose of study drug up to 2 years and 8 months |
| Best Overall Response (BOR) | Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >=7 weeks after first dose. | From the date of first dose of study drug up to 2 years and 8 months |
| Part 2: Objective Response Rate (ORR) | ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. | From screening up to 2 years and 8 months |
| Part 2: Disease Control Rate (DCR) | DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >= 7 weeks after first dose. | From the date of first dose of study drug up to 2 years and 8 months |
| Cmax: Maximum Observed Plasma Concentration for E7090 | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days) |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days) |
| AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | Part 1: Cycle 0 Day 1: 0-24 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose (Cycle 1 is 28 days) |
| Part 1: CL/F: Apparent Total Clearance for E7090 | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days) |
| Kashiwa |
| Chiba |
| Japan |
| Eisai Trial Site #1 | Matsuyama | Ehime | Japan |
| Eisai Trial Site #1 | Sapporo | Hokkaido | Japan |
| Eisai Trial Site #1 | Amagasaki | Hyōgo | Japan |
| Eisai Trial Site #1 | Tsukuba | Ibaraki | Japan |
| Eisai Trial Site #1 | Kawasaki | Kanagawa | Japan |
| Eisai Trial Site #1 | Yokohama | Kanagawa | Japan |
| Eisai Trial Site #1 | Chuo-ku | Niigata | Japan |
| Eisai Trial Site #1 | Kitaadachi | Saitama | Japan |
| Eisai Trial Site #1 | Chuo-Ku | Tokyo | Japan |
| Eisai Trial Site #1 | Koto-ku | Tokyo | Japan |
| Eisai Trial Site #1 | Chiba | Japan |
| Eisai Trial Site #1 | Fukuoka | Japan |
| Eisai Trial Site #1 | Kyoto | Japan |
| Eisai Trial Site #1 | Osaka | Japan |
| Eisai Trial Site #2 | Osaka | Japan |
| Eisai Trial Site #3 | Osaka | Japan |
| Radiological Disease Progression |
|
| BG001 | Part 1: E7090 2 mg With Solid Tumor | Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG002 | Part 1: E7090 4 mg With Solid Tumor | Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG003 | Part 1: E7090 8 mg With Solid Tumor | Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG004 | Part 1: E7090 16 mg With Solid Tumor | Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG005 | Part 1: E7090 30 mg With Solid Tumor | Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG006 | Part 1: E7090 60 mg With Solid Tumor | Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG007 | Part 1: E7090 100 mg With Solid Tumor | Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG008 | Part 1: E7090 140 mg With Solid Tumor | Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG009 | Part 1: E7090 180 mg With Solid Tumor | Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG010 | Part 2: E7090 140 mg With Gastric Cancer | Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG011 | Part 2: E7090 140 mg With Cholangiocarcinoma | Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. |
| BG012 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. | The safety analysis set was the group of participants who received at least 1 dose of E7090. This outcome measure was planned to be analyzed for Part 1 and Part 2. | Posted | Count of Participants | Participants | From the start of study drug administration up to 2 year 9 months |
|
|
|
| Secondary | Part 2: Overall Survival (OS) | OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method. | The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only. | Posted | Median | 95% Confidence Interval | months | From the date of first dose of study drug up to 2 years and 8 months |
|
|
|
| Secondary | Part 2: Progression- Free Survival (PFS) | PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method. | The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only. | Posted | Median | 95% Confidence Interval | months | From the date of first dose of study drug up to 2 years and 8 months |
|
|
|
| Secondary | Best Overall Response (BOR) | Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >=7 weeks after first dose. | The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 1 and Part 2. | Posted | Count of Participants | Participants | From the date of first dose of study drug up to 2 years and 8 months |
|
|
|
| Secondary | Part 2: Objective Response Rate (ORR) | ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. | The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only. | Posted | Number | 95% Confidence Interval | percentage of participants | From screening up to 2 years and 8 months |
|
|
|
| Secondary | Part 2: Disease Control Rate (DCR) | DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >= 7 weeks after first dose. | The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of first dose of study drug up to 2 years and 8 months |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for E7090 | The pharmacokinetic (PK) analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 and Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days) |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090 | The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 and Part 2. | Posted | Median | Full Range | hour | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days) |
|
|
|
| Secondary | AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours | The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. Here "overall number of participants analyzed" are those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for Part 1 and Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Part 1: Cycle 0 Day 1: 0-24 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose (Cycle 1 is 28 days) |
|
|
|
| Secondary | Part 1: CL/F: Apparent Total Clearance for E7090 | The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 only. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/h) | Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days) |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Part 1: E7090 2 mg With Solid Tumor | Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Part 1: E7090 4 mg With Solid Tumor | Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | Part 1: E7090 8 mg With Solid Tumor | Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 2 | 2 | 2 | 2 | 2 |
| EG004 | Part 1: E7090 16 mg With Solid Tumor | Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG005 | Part 1: E7090 30 mg With Solid Tumor | Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG006 | Part 1: E7090 60 mg With Solid Tumor | Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG007 | Part 1: E7090 100 mg With Solid Tumor | Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG008 | Part 1: E7090 140 mg With Solid Tumor | Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG009 | Part 1: E7090 180 mg With Solid Tumor | Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG010 | Part 2: E7090 140 mg With Gastric Cancer | Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 10 | 10 | 4 | 10 | 10 | 10 |
| EG011 | Part 2: E7090 140 mg With Cholangiocarcinoma | Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to <1 mg (Part 1) or <35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate. | 5 | 6 | 1 | 6 | 6 | 6 |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0. | Systematic Assessment |
|
| Tumour obstruction | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0. | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA version 24.0. | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA version 24.0. | Systematic Assessment |
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| Thrombophlebitis migrans | Vascular disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 24.0. | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Serous retinal detachment | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Subretinal fluid | Eye disorders | MedDRA version 24.0. | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Angular cheilitis | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Glossitis | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Periodontal disease | Gastrointestinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 24.0. | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 24.0. | Systematic Assessment |
|
| Malaise | General disorders | MedDRA version 24.0. | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA version 24.0. | Systematic Assessment |
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| Mucosal haemorrhage | General disorders | MedDRA version 24.0. | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA version 24.0. | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA version 24.0. | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA version 24.0. | Systematic Assessment |
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| Nail injury | Injury, poisoning and procedural complications | MedDRA version 24.0. | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA version 24.0. | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Fibrin D dimer increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Weight increased | Investigations | MedDRA version 24.0. | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0. | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0. | Systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0. | Systematic Assessment |
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| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0. | Systematic Assessment |
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| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0. | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA version 24.0. | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24.0. | Systematic Assessment |
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| Paralysis recurrent laryngeal nerve | Nervous system disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 24.0. | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 24.0. | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA version 24.0. | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA version 24.0. | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA version 24.0. | Systematic Assessment |
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| Genital haemorrhage | Reproductive system and breast disorders | MedDRA version 24.0. | Systematic Assessment |
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| Gynaecomastia | Reproductive system and breast disorders | MedDRA version 24.0. | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0. | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 24.0. | Systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24.0. | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA version 24.0. | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA version 24.0. | Systematic Assessment |
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Not provided
Not provided
| SAEs |
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| Partial Response (PR) |
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| Stable Disease (SD) |
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| Progressive Disease (PD) |
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| Not Evaluable (NE) |
|