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Completed

NCT Number: NCT01213160

Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

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

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Key information

Conditions

Cancer Advanced Solid Malignancies Neoplasms

Age range

25 year–150 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Chūōku, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD4547

Drug

film coated tablet, PO, twice daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2010
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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