MelanomaPhase 1NCT00710515
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
A Phase 1 study testing AZD6244 in people with Melanoma and Malignant Melanoma, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Malignant Melanoma
- What is being tested?
- AZD6244
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2008to Jun 2010
- 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
- Able to eat a high fat breakfast within a 30-minute period
- Advanced cancer which is refractory to standard therapies, for which no standard therapies exist
- WHO or ECOG performance status 0-2 (those with performance status 2 must have been stable with no deterioration for over 2 weeks)
Who cannot join
- Any radiotherapy or chemotherapy within 21 days prior to starting the study treatment (not including palliative radiotherapy at focal sites).
- Any evidence of severe or uncontrolled systemic disease (eg., severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy.
- Refractory nausea and vomiting, chronic GI diseases (eg., inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom4 sites
Research Site
Glasgow
Research Site
Headington
Research Site
London
Research Site
Oxford
About this study
Official title: A Phase I, Open-Label Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach
- Conditions
- Melanoma, Malignant Melanoma
- Being tested
- AZD6244
- Keywords
- Melanoma, Phase I, AZD6244
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6244Drug
75mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | with food Receives: Drug: AZD6244 |
| 2 | Experimental | without food Receives: Drug: AZD6244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether food influences the rate and extent of AZD6244 absorption
Measured: Day 1 and Day 10
Secondary outcomes (2)
To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food
Measured: Day 1, 2, 3, 8, 9, and 10
To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies
Measured: screening to 30 day post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajesh Chopra, Study director, AstraZenecaJan Schellens, Principal investigator, Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710515
- Sponsor's protocol ID
- D1532C00020
- Other IDs
- 2007-004456-37 EudraCT Number
- Status last verified
- Aug 2014
- First submitted
- 2 Jul 2008
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00710515
- Acronym / sponsor ID
- D1532C00020
- Conditions
- Melanoma, Malignant Melanoma
- Keywords
- Melanoma, Phase I, AZD6244
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 4 Jul 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 purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6244with food |
| 2 | Experimental | Drug: AZD6244without food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to eat a high fat breakfast within a 30-minute period
- Advanced cancer which is refractory to standard therapies, for which no standard therapies exist
- WHO or ECOG performance status 0-2 (those with performance status 2 must have been stable with no deterioration for over 2 weeks)
Key exclusion criteria (3 listed)
- Any radiotherapy or chemotherapy within 21 days prior to starting the study treatment (not including palliative radiotherapy at focal sites).
- Any evidence of severe or uncontrolled systemic disease (eg., severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy.
- Refractory nausea and vomiting, chronic GI diseases (eg., inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.
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 |
|---|---|---|
| AZD624475mg | Drug | 1, 2 |
Primary outcome
To assess whether food influences the rate and extent of AZD6244 absorption
Time frame: Day 1 and Day 10
2 secondary outcomes
To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food
Time frame: Day 1, 2, 3, 8, 9, and 10
To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies
Time frame: screening to 30 day post last dose
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 13 Aug 2014.
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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.
Rajesh Chopra study director
AstraZeneca
Jan Schellens principal investigator
Maastricht
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6244 in people with Melanoma and Malignant Melanoma, run by AstraZeneca at 6 sites in 2 countries.
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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Netherlands. 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 assess whether food influences the rate and extent of AZD6244 absorption (time frame: Day 1 and Day 10). 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 13 Aug 2014.