Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

NCT01213160 | Completed Phase 1 DMC

• 1 other identifier: D2610C00002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cancer; Advanced Solid Malignancies

Keywords

Phase I; cancer; solid tumours; advanced solid malignancies; dose escalation; FGFR TKI; Japanese

Outcome Measures

Primary Outcomes (18)

• 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

• Assessment of adverse events (based on CTCAE version 4.0)general examination

  General examination on day 1 in cycle 0

• Assessment of adverse events (based on CTCAE version 4.0)general examination

  General examination day 21 in cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), laboratory values

  Laboratory assessment prior to IP administration in all treatment cycles

• Assessment of adverse events (based on CTCAE version 4.0), laboratory values

  Laboratory assessment on day 1 in cycle 0

• Assessment of adverse events (based on CTCAE version 4.0), laboratory values

  Laboratory assessment day 1 cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), laboratory values

  Laboratory assessment day 8 cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), laboratory values

  Laboratory assessment day 15 cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), laboratory values

  Laboratory assessment day 21 cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements

  Vital sign measurements prior to IP administration in all treatment cycles

• Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements

  Vital sign measurements day 1 in cycle 0

• Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements

  Vital sign measurements day 2 in cycle 0

• Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements

  Vital sign measurements day 8 in cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements

  Vital sign measurements day 21 in cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)

  LVEF prior to study administration

• Assessment of adverse events (based on CTCAE version 4.0), LVEF

  LVEF on day 21 in cycle 1.

• Assessment of adverse events (based on CTCAE version 4.0), eye examination

  Eye examination prior to study administration

• Assessment of adverse events (based on CTCAE version 4.0), eye examination

  Eye examination on day 21 in cycle 1.

Secondary Outcomes (3)

• Define the maximum tolerated dose (MTD) if possible or biological effective dose.

  Up to 3 weeks

• 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

• 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

Study Arms (1)

AZD4547

EXPERIMENTAL

Drug: AZD4547

Interventions

AZD4547 DRUG

film coated tablet, PO, twice daily

AZD4547

Eligibility Criteria

• Age: 25 Years - 150 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Chūōku, Japan

Location

Research Site

Nagoya, Japan

Location

Research Site

Sapporo, Japan

Location

Related Publications (1)

• 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.

  PMID: 28070720 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Neoplasms

Interventions

AZD4547

Study Officials

• Paul Stockman

  AstraZeneca

  STUDY DIRECTOR

• Hideo Saka, MD, PhD

  National Hospital Organisation Nagoya Medical Centre

  PRINCIPAL INVESTIGATOR

• Yasuo Takahashi, MD

  National Hospital OrganisationHokkaido Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

JP (3)