Clinical trial NCT01213160: Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
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 Japanese Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Advanced Solid Malignancies
Keywords: Phase I
cancer
solid tumours
advanced solid malignancies
dose escalation
FGFR TKI
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 150
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.

Detailed description: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients with Advanced Solid Malignancies.

Eligibility criteria: Inclusion Criteria:

- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer

Exclusion Criteria:

- Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection.

Primary outcomes:
measure: Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination
timeFrame: General examination prior to IP administration in treatment cycles
measure: Assessment of adverse events (based on CTCAE version 4.0)general examination
timeFrame: General examination on day 1 in cycle 0
measure: Assessment of adverse events (based on CTCAE version 4.0)general examination
timeFrame: General examination day 21 in cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), laboratory values
timeFrame: Laboratory assessment prior to IP administration in all treatment cycles
measure: Assessment of adverse events (based on CTCAE version 4.0), laboratory values
timeFrame: Laboratory assessment on day 1 in cycle 0
measure: Assessment of adverse events (based on CTCAE version 4.0), laboratory values
timeFrame: Laboratory assessment day 1 cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), laboratory values
timeFrame: Laboratory assessment day 8 cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), laboratory values
timeFrame: Laboratory assessment day 15 cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), laboratory values
timeFrame: Laboratory assessment day 21 cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
timeFrame: Vital sign measurements prior to IP administration in all treatment cycles
measure: Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
timeFrame: Vital sign measurements day 1 in cycle 0
measure: Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
timeFrame: Vital sign measurements day 2 in cycle 0
measure: Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
timeFrame: Vital sign measurements day 8 in cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
timeFrame: Vital sign measurements day 21 in cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)
timeFrame: LVEF prior to study administration
measure: Assessment of adverse events (based on CTCAE version 4.0), LVEF
timeFrame: LVEF on day 21 in cycle 1.
measure: Assessment of adverse events (based on CTCAE version 4.0), eye examination
timeFrame: Eye examination prior to study administration
measure: Assessment of adverse events (based on CTCAE version 4.0), eye examination
timeFrame: Eye examination on day 21 in cycle 1.
Secondary outcomes:
measure: Define the maximum tolerated dose (MTD) if possible or biological effective dose.
timeFrame: Up to 3 weeks
measure: To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally.
timeFrame: Schedule of PK assessment 1. AZD4547; blood Cycle0-day1 -day21; 27 point 2. AZD4547 metabolite; blood Cycle1-day21; 1 poin 3. AZD4547; urine Cycle1-day21; 1 point
measure: To obtain a preliminary assessment of the anti-tumour effect of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1.
timeFrame: Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Paul Stockman
role: STUDY_DIRECTOR
affiliation: National Hospital Organisation Nagoya Medical Centre
name: Hideo Saka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Hospital OrganisationHokkaido Cancer Centre
name: Yasuo Takahashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saka H, Kitagawa C, Kogure Y, Takahashi Y, Fujikawa K, Sagawa T, Iwasa S, Takahashi N, Fukao T, Tchinou C, Landers D, Yamada Y. Safety, tolerability and pharmacokinetics of the fibroblast growth factor receptor inhibitor AZD4547 in Japanese patients with advanced solid tumours: a Phase I study. Invest New Drugs. 2017 Aug;35(4):451-462. doi: 10.1007/s10637-016-0416-x. Epub 2017 Jan 10.