Conditions: Breast Cancer Ovarian Cancer Gynecological Cancer Head and Neck Carcinoma Non-small Cell Lung Cancer Small Cell Lung Cancer Non-squamous Cell Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 69
Healthy volunteers: no

Brief summary:
Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors

Detailed description:
Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a selected cohort of patients to characterize the safety profile and feasibility of this combination, to obtain preliminary information on antitumor activity, to obtain preliminary information on quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to detect major drug-drug PK interactions and PK(pharmacokinetic)/PD(pharmacodynamic) correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with selected advanced solid tumors.

Arms:
arm 1: PM01183 + paclitaxel +/- bevacizumab

Interventions: intervention 1: PM01183 + paclitaxel +/- bevacizumab
Intervention descriptions: intervention 1: PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion

paclitaxel: 6 mg/ml concentrate for solution for infusion

bevacizumab: 25 mg/ml concentrate for solution for infusion

Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients

Protocol document: