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| ID | Type | Description | Link |
|---|---|---|---|
| H8K-MC-JZAF | Other Identifier | Eli Lilly and Company |
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The primary purpose of this study is to determine the objective response rate (complete and partial response) for participants who receive tasisulam after one prior systemic treatment for unresectable or metastatic melanoma.
Participants will receive a 2-hour intravenous infusion of study drug (tasisulam) once every 28 days. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Participants will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasisulam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tasisulam | Drug | Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant discontinuation are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response) | Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date. | Baseline to Measured Progressive Disease (up to 60 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Los Angeles | California | 90025 |
Study completion was defined as a participant completing 2 cycles of treatment and end of Cycle 2 radiographic assessment of response.
Interim analyses of pharmacokinetic (PK) data resulted in adjusted dosing populations to achieve desired concentrations of study drug within the targeted range.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tasisulam Dose Target 420 μg/mL Cmax | Tasisulam loading dose targeting 420 micrograms/milliliter (μg/mL) maximum concentration (Cmax) at the end of infusion administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). |
| FG001 | Tasisulam Dose Target 360 μg/mL Cmax | Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). |
| FG002 | Tasisulam Albumin-Tailored Dose | Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tasisulam Dose Target 420 μg/mL Cmax | Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). |
| BG001 |
| 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 | Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response) | Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date. | All participants who received at least one dose of study drug. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline to Measured Progressive Disease (up to 60 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 | Tasisulam Dose Target 420 μg/mL Cmax | Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C534068 | N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide |
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|
|
| Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months) |
| Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate) | Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam. | Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months) |
| Pharmacokinetics: Plasma Clearance Rate of Tasisulam | Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion |
| Overall Survival (OS) Time | OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive. | Baseline to Death from Any Cause (up to 42 Months) |
| Duration of Overall Objective Response | The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD. | Date of Response to Date of Measured PD (up to 1 Year) |
| Duration of Stable Disease (SD) | Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis. | Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year) |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events) | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. | Baseline to Study Completion (up to 60 Months) |
| Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score | FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL. | Baseline to Study Completion (up to 60 Months) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aurora | Colorado | 80045 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lakeland | Florida | 33805 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46202 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rochester | Minnesota | 55905 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Albuquerque | New Mexico | 87131 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pittsburgh | Pennsylvania | 15232 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee | 38138 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Coffs Harbour | New South Wales | 2450 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wollongong | New South Wales | 2500 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Adelaide | South Australia | 5000 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ashford | South Australia | 5035 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nedlands | Western Australia | 6009 | Australia |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other |
|
| Tasisulam Dose Target 360 μg/mL Cmax |
Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). |
| BG002 | Tasisulam Albumin-Tailored Dose | Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Tasisulam Dose Target 420 μg/mL Cmax | Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). |
| OG001 | Tasisulam Dose Target 360 μg/mL Cmax | Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). |
| OG002 | Tasisulam Albumin-Tailored Dose | Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks). |
|
|
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization. | All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 10, Tasisulam Target Cmax 360 µg/mL = 8, Albumin-Tailored Dose = 8. | Posted | Median | 95% Confidence Interval | Months | Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months) |
|
|
|
| Secondary | Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate) | Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam. | All participants who received at least one dose of study drug. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months) |
|
|
|
| Secondary | Pharmacokinetics: Plasma Clearance Rate of Tasisulam | All participants who received at least one dose of study drug and had evaluable PK data. PK analysis were performed on combined arms for total drug per protocol. | Posted | Geometric Mean | Standard Error | Liters/hour (L/h) | Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion |
|
|
|
| Secondary | Overall Survival (OS) Time | OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive. | All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 25, Tasisulam Target Cmax 360 µg/mL = 17, Albumin-Tailored Dose = 17. | Posted | Median | 95% Confidence Interval | Months | Baseline to Death from Any Cause (up to 42 Months) |
|
|
|
| Secondary | Duration of Overall Objective Response | The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD. | All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 1, Tasisulam Target Cmax 360 µg/mL = 1, Albumin-Tailored Dose = 0. | Posted | Median | 95% Confidence Interval | Months | Date of Response to Date of Measured PD (up to 1 Year) |
|
|
|
| Secondary | Duration of Stable Disease (SD) | Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis. | All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 6, Tasisulam Target Cmax 360 µg/mL = 5, Albumin-Tailored Dose = 5. | Posted | Median | 95% Confidence Interval | Months | Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year) |
|
|
|
| Secondary | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events) | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to Study Completion (up to 60 Months) |
|
|
|
| Secondary | Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score | FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL. | All participants who received at least one dose of study drug and had baseline and post baseline FACT-G data. FACT-G analysis was performed on combined arms per protocol. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Study Completion (up to 60 Months) |
|
|
|
| 24 |
| 68 |
| 58 |
| 68 |
| EG001 | Tasisulam Dose Target 360 μg/mL Cmax | Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). | 13 | 32 | 31 | 32 |
| EG002 | Tasisulam Albumin-Tailored Dose | Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks). | 11 | 30 | 29 | 30 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cerebral artery thrombosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |