NeoplasmsPhase 1NCT00088790
AZD5438 in Patients With Advanced Solid Malignancies
A Phase 1 study testing AZD5438 in people with Neoplasms, run by AstraZeneca at 2 sites in United States.
Trial summary
Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- AZD5438
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Dec 2005
- 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 malignancy
- Cancer refractory to standard treatments or for which no standard therapy exits
Who cannot join
- Radiotherapy within 3 weeks of the start of treatment
- Investigational product within the last 3 weeks
- Systemic cytotoxic anti-cancer therapy within the last 3 weeks
- Any significant clinical disorder that makes it undesirable for the patient to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Boston, Massachusetts
Research Site
New York, New York
About this study
Official title: Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies
Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.
- Conditions
- Neoplasms
- Being tested
- AZD5438
- Keywords
- advanced, 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.
AZD5438Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startJul 2004
- Primary completionDec 2005
- Study completionDec 2005
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
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088790
- Sponsor's protocol ID
- D0110C00005
- Status last verified
- Jan 2011
- First submitted
- 4 Aug 2004
- Last updated
- 26 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00088790
- Acronym / sponsor ID
- D0110C00005
- Conditions
- Neoplasms
- Keywords
- advanced, solid, malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 5 Aug 2004 (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.
Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.
Study design
- Primary purpose
- Treatment
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 malignancy
- Cancer refractory to standard treatments or for which no standard therapy exits
Key exclusion criteria (4 listed)
- Radiotherapy within 3 weeks of the start of treatment
- Investigational product within the last 3 weeks
- Systemic cytotoxic anti-cancer therapy within the last 3 weeks
- Any significant clinical disorder that makes it undesirable for the patient to participate
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 |
|---|---|---|
| AZD5438 | Drug | – |
Primary outcome
Not reported in the source record.
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 26 Jan 2011.
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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.
2 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 AZD5438 in people with Neoplasms, run by AstraZeneca at 2 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 4 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 26 Jan 2011.