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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...
CPX-1 Liposome is an investigational therapy studied for advanced colorectal cancer, also called colorectal neoplasms. It was evaluated in adult patients with advanced disease. It is not approved for commercial use and remains in clinical development.
CPX-1 Liposome is being developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker JAZZ. The company sponsored the clinical program evaluating the agent in advanced colorectal cancer.
CPX-1 Liposome is in Phase 2 clinical development. The program includes one completed Phase 2 trial in advanced colorectal cancer. No Phase 3 trial has been initiated, and the drug is not approved for any indication.
CPX-1 Liposome was studied in the completed Phase 2 trial NCT00361842, titled a multicenter study of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection in patients with advanced colorectal cancer. The trial enrolled 65 adults across the United States and Canada.
Yes, CPX-1 Liposome is the same asset as CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection. The longer name describes the liposomal formulation of irinotecan hydrochloride and floxuridine. Both names refer to the same investigational product developed by Jazz Pharmaceuticals.