Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01213160
First received: September 30, 2010
Last updated: January 8, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 28 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 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
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: | January 8, 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 June 17, 2013