Clinical trial NCT00979134: Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Advanced Solid Malignancies
Keywords: Cancer
Tumour
Advanced Solid Malignancies
FGFR
Squamous NSCLC
Gastric adenocarcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-17
Enrollment: 95
Sex: ALL
Minimum age (years): 25
Maximum age (years): 149
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Patients Who Experienced at Least 1 AE
timeFrame: AEs are monitored from screenng through to 30 day follow up period
measure: Number of Participants Who Experienced at Least 1 Causally Related AE.
timeFrame: AEs are continually assessed from screening up to 30 day FU period
measure: Number of Participants With at Least 1 AE of CTCAE >=G3
timeFrame: Ongoing up to discontinuation up to 30 day FU.
measure: Number of Participants With at Least 1 Causally Related AE of CTCAE >=G3
timeFrame: Ongoing up to discontinuation up to 30 day FU.
measure: Number of Participants Who Experienced at Least One SAE
timeFrame: Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.
measure: Number of Participants With at Least 1 Causally Related SAE
timeFrame: SAEs are continually monitored from screening to end of 30 FU period
Secondary outcomes:
measure: AUC(0-infinity)
timeFrame: PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
measure: Tumour Response (Best Objective Response) - Number of Patients With a Confirmed Response of Partial Response (PR) or Confirmed Response (CR)
timeFrame: Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.
measure: Cmax (ng/mL)
timeFrame: PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
measure: Css,Max (ng/mL)
timeFrame: PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
measure: AUC,ss(0-infinity)
timeFrame: PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Pierre Benite
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Institut de cancérologie Gustave Roussy
name: Fabrice André, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Donal Landers, Dr
role: STUDY_DIRECTOR
References: