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A clinical trial with a daily dose of E7449, a Poly(ADP-Ribose) Polymerase (PARP) Inhibitor, in patients with Advanced Solid Tumors or with Hematological Tumors and in Combination with Chemotherapy (T...

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-001959-37

A clinical trial with a daily dose of E7449, a Poly(ADP-Ribose) Polymerase (PARP) Inhibitor, in patients with Advanced Solid Tumors or with Hematological Tumors and in Combination with Chemotherapy (Temozolomide[TMZ] or with Carboplatin and Paclitaxel) in patients with Advanced Solid Tumors

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Extrait

Primary objective: - Determine maximum tolerated dose (MTD) as single agent, once daily (QD) continuously in 28-day cycles - Determine MTD of E7449, QD for 7 consecutive days in combination with TMZ, QD for 5 consecutive days in 28-day cycles - Determine the MTD of E7449, QD continuously in 21-day cycles in combination with carboplatin and paclitaxel administered via intravenous (i.V.) infusion on Day 1 of each cycle - Assess the objective response rate of E7449 as single agent in subjects with platinum-sensitive recurrent high grade serous ovarian cancer (Cohort 1) and in subjects with relapsed and/or refractory ataxia telangiectasia mutated (ATM)-deficient B-cell lymphoma (Cohort 2) - Assess the ORR of E7449 in combination with TMZ in subjects with advanced melanoma (Cohort 3) - To assess the ORR of E7449 in combination with carboplatin and paclitaxel in subjects with metastatic triple-negative breast cancer (mTNBC) (Cohort 4)

Critère d'inclusion

  • Advanced solid tumors (including ovarian cancer, triple negative breast cancer, and advanced melanoma) and B-cell lymphomas

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