Carcinoma, Renal CellPhase 1NCT00372853
Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma
A Phase 1 study testing CP-675,206 and SU011248 in people with Carcinoma, Renal Cell, run by AstraZeneca at 5 sites in United States.
Trial summary
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- CP-675,206 and SU011248
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2006to May 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
- Histologically proven renal cell carcinoma with metastases
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Who cannot join
- Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma
- History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Cleveland, Ohio, 44195
Research Site
Greenville, South Carolina, 29605
Research Site
Memphis, Tennessee, 38120
Research Site
New Brunswick, New Jersey, 08903
Research Site
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- CP-675,206, SU011248
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-675,206Drug
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
SU011248Drug
SU011248 administered at a dose of 37.5mg/day every day.
CP-675,206Drug
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
SU011248Drug
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: CP-675,206; Drug: SU011248 |
| Arm B | Experimental | Not described Receives: Drug: CP-675,206; Drug: SU011248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
Measured: 6 weeks after first dose
Secondary outcomes (4)
To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported
Measured: 18 months
To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
Measured: up to 18 months
To monitor for an antibody response to CP-675,206
Measured: up to 18 months
To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled
Measured: 6-18 months after last subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372853
- Sponsor's protocol ID
- A3671025
- Status last verified
- Jun 2012
- First submitted
- 5 Sep 2006
- 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
- A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00372853
- Acronym / sponsor ID
- A3671025
- Conditions
- Carcinoma, Renal Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Sep 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.
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: CP-675,206, Drug: SU011248 |
| Arm B | Experimental | Drug: CP-675,206, Drug: SU011248 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically proven renal cell carcinoma with metastases
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Key exclusion criteria (2 listed)
- Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma
- History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
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-675,206CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested. | Drug | Arm A |
| SU011248SU011248 administered at a dose of 37.5mg/day every day. | Drug | Arm A |
| CP-675,206CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested. | Drug | Arm B |
| SU011248SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks. | Drug | Arm B |
Primary outcome
To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
Time frame: 6 weeks after first dose
4 secondary outcomes
To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported
Time frame: 18 months
To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
Time frame: up to 18 months
To monitor for an antibody response to CP-675,206
Time frame: up to 18 months
To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled
Time frame: 6-18 months after last subject enrolled
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.
5 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 and SU011248 in people with Carcinoma, Renal Cell, run by AstraZeneca at 5 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 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 5 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 determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug (time frame: 6 weeks after first dose). 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.