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| Name | Class |
|---|---|
| Children's Oncology Group | NETWORK |
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This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of this regimen in Part A1 (participants greater than or equal to [>=] 12 months and less than [<] 18 years). Part A2 will enroll infants (greater than [>] 6 months and <12 months) one dose level behind the dose level at which participants in Part A1 are enrolling, in order to maximize safety for infant participants. Additionally, this study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate will also be described.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eribulin Mesylate | Experimental | Eribulin mesylate will be administered intravenously on Days 1 and 8 of each 21-day cycle. A cycle of therapy is considered to be 21 days. The starting dose for eribulin mesylate will be at 1.1 milligram per square meter (mg/m^2) (Dose Level 1), which is approximately 80% of the adult MTD, and will be escalated up to no more than 2.2 mg/m^2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin Mesylate | Drug | Eribulin mesylate will be administered intravenously on Days 1 and 8 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Eribulin Mesylate | MTD: maximum dose at which <one third participants had DLT in Cycle 1. DLT: Grade 3/4 drug-related non hematological toxicity (except Grade 3 nausea, vomiting of <3 days, Grade 3 liver enzyme elevation with alanine transaminase/aspartate transaminase and gamma glutamyl transferase that returned to Grade <=1 or baseline prior to next dose; Grade 3 fever, infection, hypophosphatemia, hypokalemia, hypocalcemia/hypomagnesemia responsive to oral supplementation). Non-hematological toxicity causing >=14 days delay between treatment cycles. Haematological DLTs included: Grade 4 neutropenia/platelets<75,000/mm^3 on Day 8 that does not resolve to absolute neutrophil count >=750/mm^3 and platelets>=75,000/mm^3 by Day 11, neutropenia for >7 days; platelet count <25,000/mm^3, or required platelet transfusion, on 2 separate days within 7-day period;Grade 3 thrombocytopenia complicated by bleeding and/or required platelet transfusion;myelosuppression causing >14 days delay between treatment cycles. | First dose of study drug (Baseline) up to Cycle 1 Day 21 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Overall Response | Best Overall Response (BOR): best response recorded from start of study treatment until disease progression (PD) or recurrence based on response evaluation criteria in solid tumors (RECIST) version 1.1 for target and non-target lesions. Participants with evaluable disease were also eligible for assessment. | First dose of study drug (Baseline) up to approximately Cycle 8 (21-days treatment cycle) |
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Inclusion Criteria
Participants must be >=12 months and <18 years of age at the time of study enrollment (Part A1).
Participants must be >6 months and <12 months of age at the time of study enrollment (Part A2). Participants will enroll one dose level behind the dose level at which participants in Part A1 are enrolling.
Participants with refractory or recurrent solid tumors or lymphomas, excluding CNS tumors, are eligible. Participants must have had histologic verification of malignancy at original diagnosis or relapse. Participants with primary CNS tumors, known CNS metastases, or a prior history of CNS metastases are not eligible.
Participants must have either measurable or evaluable disease.
Participants current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
Karnofsky >= 50% for participants >16 years of age and Lansky >=50 for participants less than or equal to (<=)16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Participants must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy.
Adequate Bone Marrow Function Defined as:
All participants enrolled on the study must be evaluable for hematologic toxicity.
Adequate Renal Function Defined as:
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >=70 milliliter per minute (ml/min) per (/) 1.73 square meter (m^2) or
A serum creatinine milligram per deciliter (mg/dL) based on age/gender as follows:
6 months to <1 year: male, 0.5; female, 0.5
1 to < 2 years: male, 0.6; female, 0.6
2 to < 6 years: male, 0.8; female, 0.8
6 to < 10 years: male, 1; female, 1
10 to < 13 years: male, 1.2; female, 1.2
13 to < 16 years: male, 1.5; female, 1.4
>=16 years: male, 1.7; female, 1.4
The threshold creatinine values were derived from the Schwartz formula for estimating GFR (Schwartz et al., 1985) utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC).
Adequate Liver Function Defined as:
Adequate Cardiac Function Defined as:
All participants and/or their participants or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. Participants must be willing to comply with all aspects of the protocol.
Participants with known human immunodeficiency virus (HIV) who have CD4+ T cell counts greater than or equal to 500 cells/m^3 and who do not require antiretroviral therapy are eligible.
Exclusion Criteria
Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective double barrier contraceptive method for the entire period in which they are receiving protocol therapy and up to 6 months after treatment.
Concomitant Medications
Participants who have received prior therapy with eribulin mesylate are not eligible.
Participants with hypersensitivity to excipients of the study drug are not eligible. The excipients are ethanol, hydrochloric acid, sodium hydroxide and water for injection.
Participants who have a prior history of viral hepatitis (B or C) as demonstrated by positive serology (presence of antigens) or have an uncontrolled infection requiring treatment are not eligible.
Participants with greater than Grade 1 peripheral sensory neuropathy or greater than Grade 1 peripheral motor neuropathy graded according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies are not eligible.
Cardiac Pathology
CNS Disease
Participants who have had or are planning to have the following invasive procedures are not eligible:
Participants with known bone marrow involvement are not eligible.
Participants who have received a prior solid organ transplantation are not eligible.
Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Childrens Hospital of Orange County |
In Part A1, a total of 23 participants of greater than or equal to (>=) 12 months were enrolled, of which 22 were treated in the study. In Part A2, the study was open for the enrolment of infant participants of less than 12 months of age, however no participants were enrolled into this part.
Participants took part in the study at 18 investigative sites in the United States from 31 July 2014 to 28 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A1: Eribulin Mesylate 1.1 mg/m^2 | Participants received eribulin mesylate (E7389) 1.1 milligram per square meter (mg/m^2), intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until progressive disease (PD) or unacceptable toxicity or drug related dose-limiting toxicities (DLT's). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Number of Participants With Clinically Significant Vital Sign Values | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| Number of Participants With Clinically Significant Electrocardiogram (EKG) | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| T1/2: Terminal Half-life for Eribulin Mesylate | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| Cmax: Maximum Observed Plasma Concentration for Eribulin Mesylate | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Eribulin Mesylate | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Eribulin Mesylate | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for Eribulin Mesylate | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| CL: Clearance for Eribulin Mesylate | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| Vd: Volume of Distribution for Eribulin Mesylate | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| Orange |
| California |
| 92868 |
| United States |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Cancer Center-Fairview | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 1914 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98145 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| FG001 |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 |
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's. |
| FG002 | Part A1: Eribulin Mesylate 1.8 mg/m^2 | Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's. |
| FG003 | Part A1: Eribulin Mesylate PK Expansion | Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of pharmacokinetics (PK). |
| COMPLETED |
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| NOT COMPLETED |
|
|
The safety analysis set (SAS) included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A1: Eribulin Mesylate 1.1 mg/m^2 | Participants received eribulin mesylate 1.1 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's. |
| BG001 | Part A1: Eribulin Mesylate 1.4 mg/m^2 | Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's. |
| BG002 | Part A1: Eribulin Mesylate 1.8 mg/m^2 | Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's. |
| BG003 | Part A1: Eribulin Mesylate PK Expansion | Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Maximum Tolerated Dose (MTD) of Eribulin Mesylate | MTD: maximum dose at which <one third participants had DLT in Cycle 1. DLT: Grade 3/4 drug-related non hematological toxicity (except Grade 3 nausea, vomiting of <3 days, Grade 3 liver enzyme elevation with alanine transaminase/aspartate transaminase and gamma glutamyl transferase that returned to Grade <=1 or baseline prior to next dose; Grade 3 fever, infection, hypophosphatemia, hypokalemia, hypocalcemia/hypomagnesemia responsive to oral supplementation). Non-hematological toxicity causing >=14 days delay between treatment cycles. Haematological DLTs included: Grade 4 neutropenia/platelets<75,000/mm^3 on Day 8 that does not resolve to absolute neutrophil count >=750/mm^3 and platelets>=75,000/mm^3 by Day 11, neutropenia for >7 days; platelet count <25,000/mm^3, or required platelet transfusion, on 2 separate days within 7-day period;Grade 3 thrombocytopenia complicated by bleeding and/or required platelet transfusion;myelosuppression causing >14 days delay between treatment cycles. | The dose evaluable set (DES) included all participants who were judged as DLT evaluable as recorded in the database. In order to be DLT evaluable, all participants had to complete Cycle 1. | Posted | Number | mg/m^2 | First dose of study drug (Baseline) up to Cycle 1 Day 21 |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. | The SAS included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | The SAS included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Vital Sign Values | The SAS included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Electrocardiogram (EKG) | The SAS included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38) |
| |||||||||||||||||||||||||||||
| Primary | T1/2: Terminal Half-life for Eribulin Mesylate | The pharmacokinetic analysis set (PAS) included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available. | Posted | Median | Full Range | hours | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| ||||||||||||||||||||||||||||
| Primary | Cmax: Maximum Observed Plasma Concentration for Eribulin Mesylate | The PAS included all participants who had sufficient PK data to derive at least one PK parameter. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| ||||||||||||||||||||||||||||
| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Eribulin Mesylate | The PAS included all participants who had sufficient PK data to derive at least one PK parameter. | Posted | Median | Full Range | hours | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| ||||||||||||||||||||||||||||
| Primary | AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Eribulin Mesylate | The PAS included all participants who had sufficient PK data to derive at least one PK parameter. | Posted | Mean | Standard Deviation | hour * nanogram per milliliter (h*ng/mL) | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| ||||||||||||||||||||||||||||
| Primary | AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for Eribulin Mesylate | The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| ||||||||||||||||||||||||||||
| Primary | CL: Clearance for Eribulin Mesylate | The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available. | Posted | Mean | Standard Deviation | milliliter per hour (mL/h) | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| ||||||||||||||||||||||||||||
| Primary | Vd: Volume of Distribution for Eribulin Mesylate | The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at pacified timepoints was available. | Posted | Mean | Standard Deviation | milliliter | Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Best Overall Response | Best Overall Response (BOR): best response recorded from start of study treatment until disease progression (PD) or recurrence based on response evaluation criteria in solid tumors (RECIST) version 1.1 for target and non-target lesions. Participants with evaluable disease were also eligible for assessment. | The SAS included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug (Baseline) up to approximately Cycle 8 (21-days treatment cycle) |
|
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
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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 A1: Eribulin Mesylate 1.1 mg/m^2 | Participants received eribulin mesylate 1.1 milligram mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's. | 0 | 6 | 2 | 6 | 6 | 6 |
| EG001 | Part A1: Eribulin Mesylate 1.4 mg/m^2 | Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Part A1: Eribulin Mesylate 1.8 mg/m^2 | Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's. | 0 | 5 | 3 | 5 | 5 | 5 |
| EG003 | Part A1: Eribulin Mesylate PK Expansion | Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. | 1 | 5 | 4 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
In Part A2, the study was open for the enrolment of infant participants of less than 12 months of age, however no participants were enrolled into this part.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai, Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C490954 | eribulin |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Part A1: Eribulin Mesylate 1.8 mg/m^2 | Participants received eribulin mesylate 1.8 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's. |
| OG003 | Part A1: Eribulin Mesylate PK Expansion | Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
| Part A1: Eribulin Mesylate PK Expansion |
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
| Part A1: Eribulin Mesylate PK Expansion |
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
| OG003 |
| Part A1: Eribulin Mesylate PK Expansion |
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
| OG003 |
| Part A1: Eribulin Mesylate PK Expansion |
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
| Part A1: Eribulin Mesylate PK Expansion |
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
| Part A1: Eribulin Mesylate PK Expansion |
Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|
| OG003 | Part A1: Eribulin Mesylate PK Expansion | Participants received eribulin mesylate 1.4 mg/m^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK. |
|
|