Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

AstraZeneca

Status and phase

Terminated

Phase 1

Conditions

Cancer

Advanced Solid Malignancies

Treatments

Drug: AZD4547

Study type

Interventional

Funder types

Industry

Identifiers

NCT00979134

D2610C00001

Details and patient eligibility

About

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.

Enrollment

95 patients

Sex

All

Ages

25 to 149 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Minimum life expectancy of 12 weeks
The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
Expansion, 5 groups of advanced cancer
Solid tumours,FGFR1 and/or FGFR2 gene amplified
Squamous NSCLC, FGFR1 gene low & high amplified
Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
Aged at least 25 years

Exclusion criteria

Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
An inability to be able to take the study medication
A bad reaction to AZD4547 or any drugs similar to it in structure or class.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

95 participants in 3 patient groups

Part A

Experimental group

Description:

Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)

Treatment:

Drug: AZD4547

Part B

Experimental group

Description:

Dose expansion phase, at the RD defined in Part A

Treatment:

Drug: AZD4547

Part C

Experimental group

Description:

Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A