Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01213160
First received: September 30, 2010
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Cancer
Advanced Solid Malignancies
Drug: AZD4547
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0)general examination [ Time Frame: General examination on day 1 in cycle 0 ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0)general examination [ Time Frame: General examination day 21 in cycle 1. ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment prior to IP administration in all treatment cycles ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment on day 1 in cycle 0 ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 1 cycle 1. ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 8 cycle 1. ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 15 cycle 1. ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 21 cycle 1. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 1 in cycle 0 ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 2 in cycle 0 ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 8 in cycle 1. ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 21 in cycle 1. ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF) [ Time Frame: LVEF prior to study administration ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), LVEF [ Time Frame: LVEF on day 21 in cycle 1. ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), eye examination [ Time Frame: Eye examination prior to study administration ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events (based on CTCAE version 4.0), eye examination [ Time Frame: Eye examination on day 21 in cycle 1. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Define the maximum tolerated dose (MTD) if possible or biological effective dose. [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD4547 Drug: AZD4547
film coated tablet, PO, twice daily

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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213160

Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paul Stockman AstraZeneca
Principal Investigator: Hideo Saka, MD, PhD National Hospital Organisation Nagoya Medical Centre
Principal Investigator: Yasuo Takahashi, MD National Hospital OrganisationHokkaido Cancer Centre
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01213160     History of Changes
Other Study ID Numbers: D2610C00002
Study First Received: September 30, 2010
Last Updated: August 1, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I
cancer
solid tumours
advanced solid malignancies
dose escalation
FGFR TKI
Japanese

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014