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An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination with Carboplatin + Gemcitabine versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients with Platinum...

Update Il y a 4 ans
Reference: EUCTR2009-016050-41

An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination with Carboplatin + Gemcitabine versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients with Platinum-Sensitive Recurrent Ovarian Cancer by CA125

Woman Man

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Extract

• Phase Ib: to define the maximum tolerated dose (MTD)/ recommended Phase II of E7080 administered in combination with carboplatin + gemcitabine in patients with platinum-sensitive recurrent ovarian cancer. • Phase II: to evaluate the safety and tolerability of E7080 administered in combination with carboplatin + gemcitabine, compared with carboplatin + gemcitabine alone, in patients with platinum-sensitive recurrent ovarian cancer.

Inclusion criteria

  • Platinum sensitive recurrent ovarian cancer

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