A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects with Advanced Malignancies (ORAX-01-13-US)
This is a nonrandomized, open-label, uncontrolled, single group assignment, safety and activity study in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.Part 1 of this study is a 3+3 design to define the MTD of Oraxol in subjects with histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures donot exist or are no longer effective. Up to 24 evaluable subjects may receive Oraxol during part 1A of this study and up to 18 may receive Oraxol during part 1B. An additional 10 subjects with histologically or cytologically confirmeddiagnosis of advanced solid tumor may receive Oraxol during part 2 of the study to further establish the recommended Phase 2 dose (RP2D), safety, and tolerability. Oraxol is a combination of Paclitaxel 270 mg [nine (9) 30 mg capsules] and HM30181AK-US [one (1) 15 mg tablet].For Day 1 of each dosing week, study drugs will be in blister packs and embedded into the one child resistant card containing nine 30-mg paclitaxel capsules and one 15mg HM30181AK-US tablet. For all subsequent dosing days thatweek, blister packs will embedded into the child resistant card containing nine 30 mg paclitaxel capsules only.
Patients with advanced metastatic solid tumor cancer for which there is no standard curative treatment.
Oraxol is a combination of paclitaxel with a novel P-glycoprotein (P-gp) inhibitor, HM30181 Methanesulfonate monohydrate. Experience to date indicates that co-administration of HM30181A tablet or HM30181AK tablet (both earlierformulations of HM30181 Methanesulfonate monohydrate) allows for clinically relevant levels of paclitaxel to be achievedfollowing oral dosing (Kwak et al). Oraxol is intended to allow for oral treatment of paclitaxel responsive cancers.Oraxol may represent a clinically useful alternative to IV paclitaxel. This study will further define the clinical use of Oraxolby defining the MTD, pharmacokinetics, and safety of Oraxol at daily paclitaxel doses of 270 mg (approximately 150mg/m2).
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