|Title||Mateon OX4325 (FOCUS)|
|Principal Investigator/ Physician||Rodney Rocconi, MD|
|Protocol No.||OX4325 (FOCUS)|
|Contact Email||MCI Clinical Trials|
Protocol: FOCUS: A Multicenter, Multinational, Double-Blind, 2- Arm, Randomized, Phase 213. Study of Physician's Choice Chemotherapy ([PCC] Weekly Paclilaxel or Pegylated Liposomal Doxor ubicin [PLO]) Plus Bevacizumab and CA4P Versus PCC Plus Bcvacizumab and Placebo for Subjects with Platinum-Resis tant. Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Inclusion Criteria: ECOG PS of 0-1; Histologically or cytologically-confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer in recurrent stage; prOC (platinum-resistant ovarian cancers) defined as progression within > 1 to < 6 months (+ 2 weeks) of completing previous cycle of primary platinum-based therapy, or during or within < 6 months (+ 2 weeks) of starting additional platinum based therapies; Received ≥ 1 but ≤ 3 prior platinum-based regimens; Measurable disease; Left ventricular ejection fraction (LVEF) greater than or equal to at least 45% at baseline assessment if subject is receiving PLD, and/or anthracycline is a concomitant medication; No evidence of active (progressing) brain metastasis.
Exclusion Criteria: Subjects who have received prior CA4P therapy; Previously having failed treatment with bevacizumab combined with the intended PCC; Previous treatment with greater than three traditional chemotherapy treatment regimens; Untreated brain metastasis or leptomeningeal brain metastasis; Solid organ or bone marrow transplant; Primary platinum-refractory disease (defined as progression during dosing or within one (1) month of completing the last cycle of patients first platinum-containing regimen); > Grade 2 peripheral neuropathy; Current thrombotic or hemorrhagic disorder/event or history of prior event within 6 months of start of Screening; History of prior cerebrovascular event, (including transient ischemic attack) within 6 months of start of Screening.
Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02641639?term=Mateon+Focus&rank=1
© 2018 USA Health System