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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

Tracking Information
First Submitted Date  ICMJE September 30, 2010
First Posted Date  ICMJE October 1, 2010
Last Update Posted Date June 29, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2010)
  • 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)general examination [ Time Frame: General examination on day 1 in cycle 0 ]
  • 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), laboratory values [ Time Frame: Laboratory assessment prior to IP administration in all treatment cycles ]
  • 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 day 1 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 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), 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), 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 8 in cycle 1. ]
  • 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), 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), eye examination [ Time Frame: Eye examination prior to study administration ]
  • Assessment of adverse events (based on CTCAE version 4.0), eye examination [ Time Frame: Eye examination on day 21 in cycle 1. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2010)
  • Define the maximum tolerated dose (MTD) if possible or biological effective dose.
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Advanced Solid Malignancies
Intervention  ICMJE Drug: AZD4547
film coated tablet, PO, twice daily
Study Arms  ICMJE Experimental: AZD4547
Intervention: Drug: AZD4547
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2010)
24
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 150 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01213160
Other Study ID Numbers  ICMJE D2610C00002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account AstraZeneca
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP