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Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01213160
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Cancer Advanced Solid Malignancies Drug: AZD4547 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD4547 Drug: AZD4547
film coated tablet, PO, twice daily


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Assessment of adverse events (based on CTCAE version 4.0)general examination [ Time Frame: General examination on day 1 in cycle 0 ]
  3. Assessment of adverse events (based on CTCAE version 4.0)general examination [ Time Frame: General examination day 21 in cycle 1. ]
  4. Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment prior to IP administration in all treatment cycles ]
  5. Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment on day 1 in cycle 0 ]
  6. Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 1 cycle 1. ]
  7. Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 8 cycle 1. ]
  8. Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 15 cycle 1. ]
  9. Assessment of adverse events (based on CTCAE version 4.0), laboratory values [ Time Frame: Laboratory assessment day 21 cycle 1. ]
  10. 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 ]
  11. Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 1 in cycle 0 ]
  12. Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 2 in cycle 0 ]
  13. Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 8 in cycle 1. ]
  14. Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements [ Time Frame: Vital sign measurements day 21 in cycle 1. ]
  15. Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF) [ Time Frame: LVEF prior to study administration ]
  16. Assessment of adverse events (based on CTCAE version 4.0), LVEF [ Time Frame: LVEF on day 21 in cycle 1. ]
  17. Assessment of adverse events (based on CTCAE version 4.0), eye examination [ Time Frame: Eye examination prior to study administration ]
  18. Assessment of adverse events (based on CTCAE version 4.0), eye examination [ Time Frame: Eye examination on day 21 in cycle 1. ]

Secondary Outcome Measures :
  1. Define the maximum tolerated dose (MTD) if possible or biological effective dose. [ Time Frame: Up to 3 weeks ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 150 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213160


Locations
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Japan
Research Site
Chuo-ku, Japan
Research Site
Nagoya-shi, Japan
Research Site
Sapporo-shi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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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
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01213160    
Other Study ID Numbers: D2610C00002
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Keywords provided by AstraZeneca:
Phase I
cancer
solid tumours
advanced solid malignancies
 dose escalation
FGFR TKI
Japanese
Additional relevant MeSH terms:
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Neoplasms