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Also known as CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
CPX-1 Liposome · 1 trial · 1 indication
Disease response was assessed using RECIST 1.0. Measurable disease and target lesions were determined prior to study entry. Changes in the largest diameter (unidimensional measurement) of the sum of the target tumor lesions were used in the RECIST criteria. Best response on study was classified as follows. Complete Response (CR), disappearance of all clinical and radiological evidence of tumor. Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters. Stable Disease (SD), steady state of disease. Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD. Progressive Disease (PD) at least a 20% increase in the sum of the longest diameters of measured lesions taking as references the smallest sum of longest diameters recorded since the treatment started. Appearance of new lesions also constituted progressive disease.
Progression-free survival (PFS) was defined as the time from the first dose to the documentation of progressive disease (PD), death, or lost to follow-up at last assessment visit.
| Arm | Type | Description |
|---|---|---|
| Irinotecan | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection | DRUG | CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. |
Inclusion Criteria: * Ability to understand and voluntarily sign an informed consent form * Age \> 18 years at the time of signing the informed consent form * Histological confirmation of advanced stage, primary or metastatic colorectal carcinoma * Prior therapy (Group 1, irinotecan naive): * No...