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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00979134

First received: September 16, 2009

Last updated: June 25, 2015

Last verified: June 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2009

Last Updated Date

June 25, 2015

Start Date ^ICMJE

October 2009

Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To investigate the safety and tolerability of AZD4547 when given orally to patients with advanced solid malignancies and define the maximum tolerated dose (MTD). [ Time Frame: Safety Blood samples weekly throughout dosing. Physical Examination every 3 weeks. ECG and vital signs at least every 3 weeks. ] [ Designated as safety issue: Yes ]
To investigate the safety and tolerability of AZD4547 when given orally to patients with advanced solid malignancies and define the maximum tolerated dose (MTD). [ Time Frame: Ophthalmology at baseline and 3 weeks after start of BD dosing. MUGA / Echocardiogram at baseline, 3 weeks after start of BD dosing, and then every 3 months. ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00979134 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after multiple dosing when given orally. [ Time Frame: PK samples out to 96 hours after single dose. Staeady State PK profile 3 weeks after 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 v1.1. [ Time Frame: Baseline assessment, then assessment every 6 weeks after start of treatment. ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer
Advanced Solid Malignancies

Intervention ^ICMJE

Drug: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Drug: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Drug: AZD4547
Single dose is followed by washout 5-10 days before multiple dose

Study Arm (s)

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)

Intervention: Drug: AZD4547
Experimental: Part B
Dose expansion phase, at the RD defined in Part A

Intervention: Drug: AZD4547
Experimental: Part C
Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A

Intervention: Drug: AZD4547

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

979

Completion Date

March 2015

Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

25 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, France, Germany, Italy, Netherlands, Spain, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00979134

Other Study ID Numbers ^ICMJE

D2610C00001

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Fabrice André, Dr	Institut de cancérologie Gustave Roussy
Study Director:	Donal Landers, Dr	AstraZeneca

Information Provided By

AstraZeneca

Verification Date

June 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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