CancerPhase 1NCT00613652
A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients
A Phase 1 study testing AZD4877 in people with Cancer and Tumors, run by AstraZeneca at 1 site in Japan.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies Read more about this study
- Who is it for?
- Ages 20 to 75 years
- What is being tested?
- AZD4877
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2008to Jun 2009
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments.
- Patients who usually have mild symptoms capable of walking and light and sedentary work.
- Patients who can stay in hospital at least during 4 weeks.
Who cannot join
- Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin.
- Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function.
- Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly in Japanese Adult Patients With Advanced Solid Malignancies
The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
- Being tested
- AZD4877
- Keywords
- solid tumors, solid malignancies
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4877Drug
10 mg IV (3 weeks treatment 1 week rest)
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
Measured: weekly
Secondary outcomes (1)
To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613652
- Sponsor's protocol ID
- D2782C00008
- Status last verified
- Jul 2009
- First submitted
- 31 Jan 2008
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly in Japanese Adult Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00613652
- Acronym / sponsor ID
- D2782C00008
- Keywords
- solid tumors, solid malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Feb 2008 (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 evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments.
- Patients who usually have mild symptoms capable of walking and light and sedentary work.
- Patients who can stay in hospital at least during 4 weeks.
Key exclusion criteria (3 listed)
- Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin.
- Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function.
- Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.
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 |
|---|---|---|
| AZD487710 mg IV (3 weeks treatment 1 week rest) | Drug | – |
Primary outcome
To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
Time frame: weekly
1 secondary outcome
To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
Time frame: weekly
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 21 Jul 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4877 in people with Cancer and Tumors, run by AstraZeneca at 1 site 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 3 inclusion and 3 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 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2009.