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

Purpose

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.

Condition	Intervention	Phase
Cancer Advanced Solid Malignancies	Drug: AZD4547	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients With Advanced Solid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To investigate the safety and tolerability of AZD4547 when given orally to patients with advanced solid malignancies and define the maximum tolerated dose (MTD) and/or a continuous, tolerable dose Recommended Dose (RD). [ Time Frame: Blood samples weekly during dosing. Physical Exam every 3 weeks. ECG & vital, minimum every 3 weeks. Ophthalmology at baseline, monthly for 3 months then every 8 weeks. MUGA/Echocardiogram at baseline, 3 weeks after start of dosing and every 3 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally. [ Time Frame: PK samples out to 96 hours after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing. ] [ Designated as safety issue: No ]
To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 [ Time Frame: Baseline assessment, then assessment every 6 weeks after start of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part A Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)	Drug: AZD4547 Single dose is followed by washout 5-10 days before multiple dose
Experimental: Part B Dose expansion phase, at the RD defined in Part A	Drug: AZD4547 Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Experimental: Part C Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A	Drug: AZD4547 Patients start at a dose of 80 mg twice daily, with no washout

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979134

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Show 26 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Fabrice André, Dr	Institut de cancérologie Gustave Roussy
Study Director:	Paul Stockman, Dr	AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00979134 History of Changes
Other Study ID Numbers:	D2610C00001
Study First Received:	September 16, 2009
Last Updated:	April 10, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Italy: Ethics Committee

Keywords provided by AstraZeneca:

Cancer
Tumour
Advanced Solid Malignancies

FGFR
Squamous NSCLC
Gastric adenocarcinoma

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013