A Phase 1 dose-finding and Phase 2 randomized double-blinded study evaluating if veliparib compared to placebo improves efficacy of caboplatin and etoposide combination in patients with untreated exte...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-001764-35

A Phase 1 dose-finding and Phase 2 randomized double-blinded study evaluating if veliparib compared to placebo improves efficacy of caboplatin and etoposide combination in patients with untreated extensive stage small cell lung cancer

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Extrait

The Phase 1 primary objective is to establish the maximum tolerated dose and the recommended Phase 2 dose for veliparib in combination with carboplatin and etoposide in subjects with untreated extensive stage disease small cell lung cancer and to evaluate the pharmacokinetic interaction between veliparib and etoposide. The Phase 2 primary objective is to evaluate if veliparib vs. placebo in combination with carboplatin and etoposide followed by veliparib vs. placebo as maintenance monotherapy results in improved progression free survival (PFS).


Critère d'inclusion

  • extensive-stage disease small cell lung cancer (ED SCLC)