Date: 2015-02-03
Type of information: DSMB assessment
phase: 3
Announcement: DSMB assessment
Company: CTI Biopharma - previously known as Cell Therapeutics (USA - WA)
Product: Opaxio™ (paclitaxel poliglumex)
Action
mechanism: taxane derivative. Opaxio™ (paclitaxel poliglumex, CT-2103), is an investigational, biologically enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue\'s exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as Opaxio®. Based on preclinical studies, it appears that Opaxio® is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel. Unlike standard radiosensitizing agents, Opaxio® appears tumor selective and does not appear to enhance radiation toxicity to normal tissues.
Disease: maintenance therapy in ovarian cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The GOG-0212 study is a randomized, multicenter, open label Phase 3 trial of either monthly Opaxio® or paclitaxel for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy. For purposes of registration, the primary endpoint of the study is overall survival of patients treated with Opaxio compared to no maintenance therapy. Secondary endpoints are progression-free survival, safety and quality of life. The statistical analysis plan calls for up to four interim analyses and one final analysis, each with boundaries for early closure for superior efficacy or for futility. The first interim analysis was conducted in January 2013, which passed the futility boundary and continued with no changes. (NCT00108745) The trial is being conducted and managed by the Gynecologic Oncology Group, now part of NRG Oncology, which is one of the National Cancer Institute\'s funded cooperative cancer research groups with a focus on the study of gynecologic malignancies.
Latest
news: * On February 3, 2015, CTI BioPharma announced that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI BioPharma that an independent Data Monitoring Committee (DMC) recommended continuation of the GOG-0212 Phase 3 clinical study of Opaxio™ (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a second of four planned interim analyses for survival and futility. CTI BioPharma remains blinded to the interim analysis results. GOG-0212 is the largest maintenance study in this setting, having enrolled 1,150 patients. * On January 28, 2014, Cell Therapeutics announced that the Gynecologic Oncology Group (GOG) informed CTI that it has completed patient enrollment in the GOG-0212 Phase 3 clinical trial of investigational agent paclitaxel poliglumex (Opaxio™ ) as maintenance therapy in ovarian cancer.
