CancerPhase 1NCT01213160
Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
A Phase 1 study testing AZD4547 in people with Cancer and Advanced Solid Malignancies, run by AstraZeneca at 3 sites in Japan.
Trial summary
The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 25 to 150 years
- Conditions the study is for
- Cancer, Advanced Solid Malignancies
- What is being tested?
- AZD4547
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesJapan
- Study dates
- Nov 2010to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
About this study
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
The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.
Read the 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.
- Conditions
- Cancer, Advanced Solid Malignancies
- Being tested
- AZD4547
- Keywords
- Phase I, cancer, solid tumours, advanced solid malignancies, dose escalation, FGFR TKI, Japanese
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4547Drug
film coated tablet, PO, twice daily
| Study group | Role | What they receive |
|---|---|---|
| AZD4547 | Experimental | Not described Receives: Drug: AZD4547 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination
Measured: General examination prior to IP administration in treatment cycles
Assessment of adverse events (based on CTCAE version 4.0)general examination
Measured: General examination on day 1 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0)general examination
Measured: General examination day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Measured: Laboratory assessment prior to IP administration in all treatment cycles
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Measured: Laboratory assessment on day 1 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Measured: Laboratory assessment day 1 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Measured: Laboratory assessment day 8 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Measured: Laboratory assessment day 15 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
Measured: Laboratory assessment day 21 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Measured: Vital sign measurements prior to IP administration in all treatment cycles
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Measured: Vital sign measurements day 1 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Measured: Vital sign measurements day 2 in cycle 0
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Measured: Vital sign measurements day 8 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
Measured: Vital sign measurements day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)
Measured: LVEF prior to study administration
Assessment of adverse events (based on CTCAE version 4.0), LVEF
Measured: LVEF on day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), eye examination
Measured: Eye examination prior to study administration
Assessment of adverse events (based on CTCAE version 4.0), eye examination
Measured: Eye examination on day 21 in cycle 1.
Secondary outcomes (3)
Define the maximum tolerated dose (MTD) if possible or biological effective dose.
Measured: Up to 3 weeks
To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally.
Measured: 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.
Measured: Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Stockman, Study director, AstraZenecaHideo Saka, MD, PhD, Principal investigator, National Hospital Organisation Nagoya Medical CentreYasuo Takahashi, MD, Principal investigator, National Hospital OrganisationHokkaido Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213160
- Sponsor's protocol ID
- D2610C00002
- Status last verified
- Jun 2016
- First submitted
- 30 Sep 2010
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28070720
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01213160
- Acronym / sponsor ID
- D2610C00002
- Conditions
- Cancer, Advanced Solid Malignancies
- Keywords
- Phase I, cancer, solid tumours, advanced solid malignancies, dose escalation, FGFR TKI, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD4547 | Experimental | Drug: AZD4547 |
Who may qualify
- Ages
- 25 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4547film coated tablet, PO, twice daily | Drug | AZD4547 |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Derived from this study: PubMed 28070720Saka 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.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Stockman study director
AstraZeneca
Hideo Saka, MD, PhD principal investigator
National Hospital Organisation Nagoya Medical Centre
Yasuo Takahashi, MD principal investigator
National Hospital OrganisationHokkaido Cancer Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4547 in people with Cancer and Advanced Solid Malignancies, run by AstraZeneca at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01213160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.