Conditions: Cancer Advanced Solid Malignancies
Keywords: Cancer Tumour Advanced Solid Malignancies FGFR Squamous NSCLC Gastric adenocarcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 95
Healthy volunteers: no

Brief summary:
This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

Detailed description:

Arms:
arm 1: Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) arm 2: Dose expansion phase, at the RD defined in Part A arm 3: Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A

Interventions: intervention 1: AZD4547 intervention 2: AZD4547 intervention 3: AZD4547
Intervention descriptions: intervention 1: Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily intervention 2: Patients start at a dose of 80 mg twice daily, with no washout intervention 3: Single dose is followed by washout 5-10 days before multiple dose

Protocol document: