Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213160
• Other study ID #: D2610C00002
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2010
• Last updated: June 28, 2016
• Start date: November 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 150 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Cancer
• Neoplasms

Intervention

Drug:
• AZD4547
film coated tablet, PO, twice daily

Locations

Country	Name	City	State
Japan	Research Site	Chuo-ku
Japan	Research Site	Nagoya-shi
Japan	Research Site	Sapporo-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination		General examination prior to IP administration in treatment cycles	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0)general examination		General examination on day 1 in cycle 0	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0)general examination		General examination day 21 in cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), laboratory values		Laboratory assessment prior to IP administration in all treatment cycles	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), laboratory values		Laboratory assessment on day 1 in cycle 0	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), laboratory values		Laboratory assessment day 1 cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), laboratory values		Laboratory assessment day 8 cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), laboratory values		Laboratory assessment day 15 cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), laboratory values		Laboratory assessment day 21 cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements		Vital sign measurements prior to IP administration in all treatment cycles	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements		Vital sign measurements day 1 in cycle 0	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements		Vital sign measurements day 2 in cycle 0	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements		Vital sign measurements day 8 in cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements		Vital sign measurements day 21 in cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)		LVEF prior to study administration	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), LVEF		LVEF on day 21 in cycle 1.	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), eye examination		Eye examination prior to study administration	Yes
Primary	Assessment of adverse events (based on CTCAE version 4.0), eye examination		Eye examination on day 21 in cycle 1.	Yes
Secondary	Define the maximum tolerated dose (MTD) if possible or biological effective dose.		Up to 3 weeks	Yes
Secondary	To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally.		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	Yes
Secondary	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.		Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment	No

External Links

•   CSR Synopsis