TumorsPhase 1AGUSNCT00127829
Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
A Phase 1 study testing Gefitinib in people with Tumors, run by AstraZeneca at 2 sites in United States.
Trial summary
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Jan 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
- Histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists
- Life expectancy of > 12 weeks
- World Health Organization (WHO) performance status of < 2
Who cannot join
- Known severe hypersensitivity to gefitinib or any of the excipients of this product
- Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks)
- Incomplete healing from previous oncologic or other major surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Los Angeles, California
Research Site
Palm Springs, California
About this study
Official title: A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.
- Conditions
- Tumors
- Being tested
- Gefitinib
- Keywords
- Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called IRESSA®
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gefitinib (IRESSA®) Receives: Drug: Gefitinib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startJul 2005
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127829
- Sponsor's protocol ID
- D7913C00022
- Acronym
- AGUS
- Status last verified
- Apr 2009
- First submitted
- 5 Aug 2005
- Last updated
- 23 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
- ClinicalTrials.gov ID
- NCT00127829
- Acronym / sponsor ID
- AGUS / D7913C00022
- Conditions
- Tumors
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jan 2008 (actual)
- First posted
- 9 Aug 2005 (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.
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GefitinibGefitinib (IRESSA®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists
- Life expectancy of > 12 weeks
- World Health Organization (WHO) performance status of < 2
Key exclusion criteria (3 listed)
- Known severe hypersensitivity to gefitinib or any of the excipients of this product
- Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks)
- Incomplete healing from previous oncologic or other major surgery
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 |
|---|---|---|
| GefitinibAlso: IRESSA®Oral tablet | Drug | 1 |
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 23 Apr 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.
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 Gefitinib in people with Tumors, 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 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 23 Apr 2009. 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 23 Apr 2009.