NeoplasmsPhase 1NCT00389389
Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors
A Phase 1 study testing AZD4877 in people with Neoplasms, run by AstraZeneca at 3 sites in United States.
Trial summary
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- AZD4877
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to Oct 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
- Relatively good overall health other than your cancer.
Who cannot join
- Poor bone marrow function (not producing enough blood cells).
- Serious heart conditions.
- Poor liver or kidney function.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Denver, Colorado
Research Site
Houston, Texas
Research Site
Nashville, Tennessee
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis
- Conditions
- Neoplasms
- Being tested
- AZD4877
- Keywords
- Advanced Solid Malignancies, Advanced solid tumors, Cancer, Phase I, Solid tumors, Solid malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4877Drug
intravenous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment.
Measured: assessed at each treatment
Secondary outcomes (1)
Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.
Measured: Assessed after the first course of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Ochs, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389389
- Sponsor's protocol ID
- D2782C00001
- Status last verified
- Apr 2009
- First submitted
- 17 Oct 2006
- Last updated
- 1 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 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 or Every Two Weeks in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00389389
- Acronym / sponsor ID
- D2782C00001
- Conditions
- Neoplasms
- Keywords
- Advanced Solid Malignancies, Advanced solid tumors, Cancer, Phase I, Solid tumors, Solid malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Oct 2006 (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 find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
- Relatively good overall health other than your cancer.
Key exclusion criteria (3 listed)
- Poor bone marrow function (not producing enough blood cells).
- Serious heart conditions.
- Poor liver or kidney function.
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 |
|---|---|---|
| AZD4877intravenous infusion | Drug | – |
Primary outcome
To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment.
Time frame: assessed at each treatment
1 secondary outcome
Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.
Time frame: Assessed after the first course 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 1 May 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.
Judith Ochs, MD study director
AstraZeneca
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 AZD4877 in people with Neoplasms, run by AstraZeneca at 3 sites in United States.
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 2 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 1 May 2009. 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 United States. 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 identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment. (time frame: assessed at each treatment). 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 1 May 2009.