TerminatedPhase 1

Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies

Stopped: Part B was cancelled based on business decision

France31 participantsStarted 2013-04

Plain-language summary

This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC). The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin. The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. the safety or well-being of the participant or study staff;
✕. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); or
✕. the analysis of results

What they're measuring

Part A: Number of participants with dose-limiting toxicities

Timeframe: up to 18 weeks

Part B: Percentage of participants with adverse events (AEs) and serious AEs (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria

Timeframe: up to 18 weeks + 28 days

Trial details

NCT IDNCT01930292

SponsorDebiopharm International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03

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