Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000774-58 | EudraCT Number |
Not provided
Not provided
Not provided
Sites not recruiting
Not provided
| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and capecitabine is more effective in patients with previously untreated gastric cancer versus cisplatin and capecitabine alone.
This open-label, multicenter, randomized study will consist of 2 phases:
Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with fixed doses of Cisplatin and Capecitabine. This phase will enroll approximately 10 to 15 patients.
In the phase II portion, Patients will receive study treatment , E7050 in combination with Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone) for approximately six 21-day cycles (18 weeks). Beyond 18 weeks, patients who are experiencing clinical benefit may continue E7050, with or without Capecitabine (Arm 1), or may continue Capecitabine alone (Arm 2), depending on the original randomization treatment arm. Patients will continue treatment for as long as clinical benefit is sustained and the treatment is well tolerated, until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first. Patients will participate in either phase Ib or phase II.
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib: Cohort 1 and 2 and 3 | Experimental | Phase Ib: Cohort 1; 200 mg E7050 + 80 mg/m2 cisplatin + 1000 mg/m2 capecitabine Cohort 2; 300 mg E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine Cohort 3; 400 mg E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine |
|
| Phase II: Arm 1; E7050 + cisplatin+ capecitabine | Active Comparator | Phase II: Arm 1; MTD E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7050 | Drug | E7050 given orally at either 200, 300, or 400 mg once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib | On days when pharmacokinetic (PK) samples were to be drawn, a predose blood sample was obtained prior to administration of golvatinib and capecitabine. After administration of study drugs, a second postdose blood sample was taken. The amount of golvatinib in the participant's blood was analyzed and the AUC was calculated. The AUC reflects the actual body exposure to drug after administration of a dose of the drug and is dependent on the rate of elimination of the drug from the body and the dose administered. Predose samples that were below the limit of quantitation (BLQ) or missing were assigned a numerical value of zero for the calculation of AUC. Any other BLQ concentrations were assigned a value of zero. Results were expressed in nanograms·hour/milliter (ng·h/mL). | Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment. |
| Maximum Concentration (Cmax) of Golvatinib | Blood samples were drawn to analyze the amount of golvatinib in the participant's serum. Maximum concentration refers to the maximum (or peak) serum concentration of study drug in the participant's system after administration of the study drug and prior to the administration of a second dose of the study drug. Results were expressed in nanograms/milliliter (ng/mL). | Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment. |
| Number of Participants With a Treatment-Emergent Adverse Event (TEAE) | Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious AEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. A TEAE was defined as an adverse event (AE) that had an onset date, or a worsening in severity from Baseline (pretreatment), on or after the first dose of study drug up to 30 days after the date of last study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted. | Until disease progression or death for 3 years |
| Time to Progression (TTP) |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melissa Versola | Quintiles, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC - CASA | Tucson | Arizona | 85715 | United States | ||
| Boca Raton Clinical Research Associates, Inc |
Subjects were to only participate in either the Phase 1b or Phase 2 portion of the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b: Golvatinib+Capecitabine+Cisplatin | Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1b |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cisplatin | Drug | Cisplatin will be administered at 80 mg/m2 by intravenous infusion over 60 minutes on Day 1 of each 21-day treatment cycle. |
|
| capecitabine | Drug | Capecitabine will be administered at 1000 mg/m2 orally, twice daily (2000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle. |
|
| From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month. |
| Time to Maximum Concentration (Tmax) of Golvatinib | Tmax was defined as the time at which Cmax was observed for golvatinib in combination with cisplatin and capecitabine. | Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment. |
The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.
| Until disease progression or death for 3 years |
| Plantation |
| Florida |
| 33324 |
| United States |
| Robert H. Lurie Comprenhensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48084 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| University of North Carolina at Chapel Hill | Chapell Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Mercy Cancer Centerr at St. Anne | Toledo | Ohio | 43623 | United States |
| Chelyabinsk Regional Oncology Dispensary | Chelyabinsk | 454087 | Russia |
| GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen. of Healthcare and Social Developm. | Saint Petersburg | 195067 | Russia |
| FSI "SRC of Oncology n. a. N.N.Petrov of Rosmedtekhnologiy" | Saint Petersburg | 197758 | Russia |
| SI Dnipropetrovsk Medical Academy of MOHU ch of Oncology and Medical Radiology | Dnipropetrovsk | 49102 | Ukraine |
| Municipal Clinical Medical and Prophylactic Institution Donetsk Regional Antitumor Centre | Donetsk | 83092 | Ukraine |
| Kyiv City Clinical Oncological Center | Kyiv | 3115 | Ukraine |
| Lviv State Oncol. Reg. Treatment and Diagnostic Center | Lviv | 79031 | Ukraine |
| Barts and the London NHS Trust | London | Greater London | EC1A 7BE | United Kingdom |
| Sarah Cannon Research UK | London | Greater London | W1G 6AD | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| FG001 | Phase 2: Golvatinib+Capecitabine+Cisplatin | The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b. The study was terminated prior to Phase 2. |
| FG002 | Phase 2: Capecitabine + Cisplatin | Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b: Golvatinib+Capecitabine+Cisplatin | Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib | On days when pharmacokinetic (PK) samples were to be drawn, a predose blood sample was obtained prior to administration of golvatinib and capecitabine. After administration of study drugs, a second postdose blood sample was taken. The amount of golvatinib in the participant's blood was analyzed and the AUC was calculated. The AUC reflects the actual body exposure to drug after administration of a dose of the drug and is dependent on the rate of elimination of the drug from the body and the dose administered. Predose samples that were below the limit of quantitation (BLQ) or missing were assigned a numerical value of zero for the calculation of AUC. Any other BLQ concentrations were assigned a value of zero. Results were expressed in nanograms·hour/milliter (ng·h/mL). | Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis. | Posted | Median | Full Range | ng·h/mL | Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment. |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Maximum Concentration (Cmax) of Golvatinib | Blood samples were drawn to analyze the amount of golvatinib in the participant's serum. Maximum concentration refers to the maximum (or peak) serum concentration of study drug in the participant's system after administration of the study drug and prior to the administration of a second dose of the study drug. Results were expressed in nanograms/milliliter (ng/mL). | Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis. | Posted | Median | Full Range | ng/mL | Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment. |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Treatment-Emergent Adverse Event (TEAE) | Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious AEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. A TEAE was defined as an adverse event (AE) that had an onset date, or a worsening in severity from Baseline (pretreatment), on or after the first dose of study drug up to 30 days after the date of last study treatment. | Safety Population included all participants who received at least one dose of study drug and who had at least one safety assessment after the first dose of study drug. | Posted | Number | Participants | From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month. |
| |||||||||||||||||||||||||||||||||||
| Primary | Time to Maximum Concentration (Tmax) of Golvatinib | Tmax was defined as the time at which Cmax was observed for golvatinib in combination with cisplatin and capecitabine. | Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis. | Posted | Median | Full Range | Hours | Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted. | The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted. | Posted | Until disease progression or death for 3 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted. | The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted. | Posted | Until disease progression or death for 3 years |
|
|
From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month.
Safety population included all participants enrolled in Phase 1b of this study, except for those who (a) dropped out prior to receiving study drug, or (b) were without any safety assessments after the first dose of study drug. Treatment-emergent AEs, (onset date or worsening in severity from baseline after first dose of study drug), were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b: Golvatinib+Capecitabine+Cisplatin | Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants. | 5 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Palmar-Plantar erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dizziness | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Catatonia | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Cold sweat | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Electrocardiogram st segment elevation | Investigations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pallor | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Psoas abscess | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
|
The study was terminated prior to enrollment in Phase 2.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai Inc. | 888-422-4743 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C548173 | N-(2-fluoro-4-((2-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)carbonylaminopyridin-4-yl)oxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
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