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This is an open label, dose-escalation and expansion, single centre, phase Ia study . In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection were studied in patients with advanced solid tumors, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Treatment group : Irinotecan liposome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan liposome | Drug | Irinotecan liposome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | Assessed by CTCAE 4.03 | Assessed from study inclusion to 30 days after last dose |
| Dose Limiting Toxicities (DLT) | Dose limiting toxicities for patients in the treatment | DLTs will be evaluated during 21-day period following the first dose of study treatment |
| Maximal tolerated dose (MTD) | Maximum tolerated dose for patients in the treatment | after the last patient in each cohort up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | maximum time on study 12 months |
| Progression Free Survival | Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
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A dose-escalation(3+3 design) and expansion study
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| The maximum time in follow up was 12 months |
| Time to reach maximum plasma concentration (Tmax) | Tmax of total irinotecan, free irinotecan and SN-38 | up to 120 hours after the first dose |
| Maximum observed plasma concentration (Cmax) | Cmax of total irinotecan, free irinotecan and SN-38 | up to 120 hours after the first dose |
| Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t) | AUC0-t of total irinotecan, free irinotecan and SN-38 | up to 120 hours after the first dose |
| Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf) | AUC0-inf of total irinotecan, free irinotecan and SN-38 | up to 120 hours after the first dose |
| Elimination half-life (T1/2) | T1/2 of total irinotecan, free irinotecan and SN-38 | up to 120 hours after the first dose |
| Clearance of drug from plasma (CL) | CL of total irinotecan | up to 120 hours after the first dose |
| Volume of distribution (Vss) | Vss of total irinotecan | up to 120 hours after the first dose |