UnknownPhase 2

Regorafenib Versus Placebo to Treat Cholangiocarcinoma

Belgium66 participantsStarted 2014-03-14

Plain-language summary

The study is a multicenter randomized (1:1) placebo-controlled, double-blinded phase II trial aiming to demonstrate an improvement of median PFS when treating locally advanced unresectable or metastatic patients suffering from an intra-hepatic or hilum (mass-forming) cholangiocarcinoma with Regorafenib as compared to placebo, and after progression after GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum (CDDP or oxaliplatin)-based chemotherapy. The principal objective is to investigate Regorafenib efficacy by prospectively evaluating the PFS after the administration of Regorafenib combined with BSC as compared to placebo with BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in Regorafenib group).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * histologically proven intra-hepatic or hilum cholangiocarcinoma (mass forming, not "liniting" tumor), locally advanced unresectable or metastatic * progression documented after GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum-based (CDDP or oxaliplatin) chemotherapy * age \> 18 years * ECOG PS 0/1 at study entry * measurable disease according to RECIST version 1.1 * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirementsconducted within 7 days of starting to study treatment: oSerum creatinine \<1.5x upper reference range oTotal bilirubin \<1.5x ULN oAlanine transaminase (ALT) and aspartate aminotransferase (AST) \< 2.5x ULN (\<5x ULN forpatients with liver involvement of their cancer). oAmylase and lipase \<1.5x ULN. * life expectancy of at least 12 weeks * effective contraception for both male and female patients if the risk of conception exists * negative proteinuria on dipstick or 24 hours proteinuria\<1000mg * signed written informed consent Exclusion Criteria: * unability to take oral medication * any malabsorption condition * patients taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg. Clarithromycin, indinavir,itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,voriconazole) or strong CYP3A4 inducers (eg. Carbamazepine, phenobarbital, phenytoin, rifampin, St-John's Wort) (see section 8) * persistent proteinuria \>3.…

What they're measuring

Improve median PFS

Timeframe: 6 to 12 weeks

Trial details

NCT IDNCT02162914

SponsorErasme University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03