Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT01213160
• Date of registration: 30/09/2010
• Primary sponsor: AstraZeneca
• Public title: Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
• Scientific 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
• Date of first enrolment: November 2011
• Target sample size: 28
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01213160
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Paul Stockman
• Affiliation: AstraZeneca

• Name: Hideo Saka, MD, PhD
• Affiliation: National Hospital Organisation Nagoya Medical Centre

• Name: Yasuo Takahashi, MD
• Affiliation: National Hospital OrganisationHokkaido Cancer Centre

Key inclusion & exclusion 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.



Age minimum: 25 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Solid Malignancies

Cancer

Intervention(s)

Drug: AZD4547

Primary Outcome(s)

Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination [Time Frame: General examination prior to IP administration in treatment cycles]

Assessment of adverse events (based on CTCAE version 4.0), eye examination [Time Frame: Eye examination on day 21 in cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), eye examination [Time Frame: Eye examination prior to study administration]

Assessment of adverse events (based on CTCAE version 4.0), laboratory values [Time Frame: Laboratory assessment day 1 cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), laboratory values [Time Frame: Laboratory assessment day 15 cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), laboratory values [Time Frame: Laboratory assessment day 21 cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), laboratory values [Time Frame: Laboratory assessment day 8 cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), laboratory values [Time Frame: Laboratory assessment on day 1 in cycle 0]

Assessment of adverse events (based on CTCAE version 4.0), laboratory values [Time Frame: Laboratory assessment prior to IP administration in all treatment cycles]

Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF) [Time Frame: LVEF prior to study administration]

Assessment of adverse events (based on CTCAE version 4.0), LVEF [Time Frame: LVEF on day 21 in cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [Time Frame: Vital sign measurements day 1 in cycle 0]

Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [Time Frame: Vital sign measurements day 2 in cycle 0]

Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [Time Frame: Vital sign measurements day 21 in cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [Time Frame: Vital sign measurements day 8 in cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [Time Frame: Vital sign measurements prior to IP administration in all treatment cycles]

Assessment of adverse events (based on CTCAE version 4.0)general examination [Time Frame: General examination day 21 in cycle 1.]

Assessment of adverse events (based on CTCAE version 4.0)general examination [Time Frame: General examination on day 1 in cycle 0]

Secondary Outcome(s)

Define the maximum tolerated dose (MTD) if possible or biological effective dose. [Time Frame: Up to 3 weeks]

To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally. [Time Frame: 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]

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. [Time Frame: Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment]

Secondary ID(s)

D2610C00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors