MelanomaPhase 1NCT00431275
Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody
A Phase 1 study testing CP-675,206 in people with Melanoma, run by AstraZeneca at 8 sites in United States.
Trial summary
This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- CP-675,206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2006to Feb 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
- Stage III or Stage IV melanoma
- No evidence of disease following resection of melanoma lesions
- Recovered from all prior surgical or adjuvant treatment-related toxicities
Who cannot join
- History of chronic inflammatory or autoimmune disease
- History of inflammatory bowel disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80010
Research Site
Aventura, Florida, 33180
Research Site
Miami Beach, Florida, 33140
Research Site
New York, New York, 10016
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Scottsdale, Arizona, 85260
About this study
Official title: An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.
- Conditions
- Melanoma
- Being tested
- CP-675,206
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-675,206Drug
Also called anti-CTLA4 human monoclonal antibody
CP-675,206 15 mg/kg iv single dose on Day 1
CP-675,206Drug
CP-675,206 15 mg/kg iv single dose on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Commercial Formulation | Experimental | Commercial Formulation Receives: Drug: CP-675,206 |
| Current Formulation | Experimental | Current Formulation Receives: Drug: CP-675,206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: maximum plasma concentration of CP-675,206
Measured: 1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve
Measured: Time 0 to Day 85
Secondary outcomes (4)
Human-anti-human antibodies
Measured: 1 year
Adverse events
Measured: 1 year
Safety laboratory tests
Measured: 1 year
Proportion of patients alive and free of disease at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startJun 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431275
- Sponsor's protocol ID
- A3671011
- Status last verified
- Jun 2012
- First submitted
- 2 Feb 2007
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
- ClinicalTrials.gov ID
- NCT00431275
- Acronym / sponsor ID
- A3671011
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Feb 2007 (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 is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial Formulation | Experimental | Drug: CP-675,206Commercial Formulation |
| Current Formulation | Experimental | Drug: CP-675,206Current Formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage III or Stage IV melanoma
- No evidence of disease following resection of melanoma lesions
- Recovered from all prior surgical or adjuvant treatment-related toxicities
Key exclusion criteria (2 listed)
- History of chronic inflammatory or autoimmune disease
- History of inflammatory bowel disease
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 |
|---|---|---|
| CP-675,206Also: anti-CTLA4 human monoclonal antibodyCP-675,206 15 mg/kg iv single dose on Day 1 | Drug | Commercial Formulation |
| CP-675,206CP-675,206 15 mg/kg iv single dose on Day 1 | Drug | Current Formulation |
Primary outcome
Pharmacokinetics: maximum plasma concentration of CP-675,206
Time frame: 1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve
Time frame: Time 0 to Day 85
4 secondary outcomes
Human-anti-human antibodies
Time frame: 1 year
Adverse events
Time frame: 1 year
Safety laboratory tests
Time frame: 1 year
Proportion of patients alive and free of disease at 1 year
Time frame: 1 year
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 6 Jun 2012.
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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.
8 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 CP-675,206 in people with Melanoma, run by AstraZeneca at 8 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 2 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Pharmacokinetics: maximum plasma concentration of CP-675,206 (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 6 Jun 2012.