This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Research Site
Paris, France
Research Site
Pierre-Bénite, France
Research Site
Amsterdam, Netherlands
Research Site
Groningen, Netherlands
To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.
Time frame: Assessed at each visit
To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm.
Time frame: Assessed at each visit
To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers.
Time frame: Assessment at end of study
To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters.
Time frame: Predetermined timepoints after dose administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Oslo, Norway
Research Site
Glasgow, United Kingdom
Research Site
Sutton, United Kingdom