Conditions: Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib in Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1 (Plk1) inhibitor in advanced cancer patients.

Detailed description:

Arms:
arm 1: Patient to receive low, middle and high doses of Volasertib IV

Interventions: intervention 1: Volasertib, low dose, d1q3w intervention 2: Volasertib, middle dose, d1q3w intervention 3: Volasertib, high dose, d1q3w
Intervention descriptions: intervention 1: Patient to receive low dose of Volasertib IV intervention 2: Patient to receive middle dose of Volasertib IV intervention 3: Patient to receive high dose of Volasertib IV

Protocol document: