MelanomaPhase 1NCT00585000
A Study To Assess The Safety Of Administering CP-675,206 As A One Hour Infusion In Patients With Surgically Incurable Advanced Melanoma
A Phase 1 study testing CP-675,206 in people with Melanoma, run by AstraZeneca at 8 sites in United States.
Trial summary
This will show if CP-675,206 can be administered safely as an intravenous infusion lasting one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours. 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
- 49 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2007to Jan 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 confirmed melanoma that is surgically incurable Note: Prior therapies for melanoma, including cancer vaccines, are permitted but are not required. There is no limit to the number of prior regimens for melanoma a patient may have received.
- Evidence of at least one lesion
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- CT scan of the brain with contrast or MRI of the brain within 6 weeks prior to enrollment showing no evidence of active brain metastases. PET scans and PET/CT scans are also acceptable.
Who cannot join
- Previous treatment with other anti CTLA4 agents (eg, ipilimumab, MDX 010).
- Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of CP 675,206 and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma.
- History of chronic autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, etc.).
- History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT scan only.
- Brain metastases that have not been adequately treated with surgery or stereotactic radiosurgery and have not been stable at least 3 months prior to enrollment.
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, 80045
Research Site
Durham, North Carolina, 27710
Research Site
Indianapolis, Indiana, 46202
Research Site
Los Angeles, California, 90095-7423
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202
Research Site
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1, Open Label, Single Arm Study To Establish The Safety Of Administering CP 675,206 As A One Hour Infusion In Patients With Surgically Incurable Stage III Or Stage IV Melanoma
This will show if CP-675,206 can be administered safely as an intravenous infusion lasting one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.
Read the detailed description
This study was prematurely discontinued on April 28, 2008 because a concomitant Phase 3 study met pre-specified futility criteria. The decision to close enrollment early was not based on any safety concerns.
- 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
15 mg/kg. IV (in the vein) over 1 hour on Day 1 of each 90 day cycle. Number of cycles: maximum of 4 cycles unless progression of disease or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CP-675,206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability during and for 1 hour following a 15 mg/kg dose of CP 675,206 administered as a one hour infusion.
Measured: Last patient dosed = 31Dec2009
Secondary outcomes (5)
To monitor for human anti human (HAHA) response to CP 675,206
Measured: Last HAHA time point obtain =estimated 31Dec2009
To assess evidence of anti tumor activity as measured by best overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) criteria, duration of response, progression free survival
Measured: Last RECIST obtained = estimated 31Dec2009
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of subjects treated with CP 675,206
Measured: Last PG obtained = estimated 31Dec2009
To evaluate the overall safety and tolerability of CP 675,206 in this population
Measured: Last patient dosed = estimated 31Dec2009
To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion
Measured: Last PK timepoint obtained =estiamted 31Dec2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585000
- Sponsor's protocol ID
- A3671022
- Status last verified
- Jun 2012
- First submitted
- 21 Dec 2007
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ribas A, Chesney JA, Gordon MS, Abernethy AP, Logan TF, Lawson DH, Chmielowksi B, Glaspy JA, Lewis K, Huang B, Wang E, Hsyu PH, Gomez-Navarro J, Gerhardt D, Marshall MA, Gonzalez R. Safety profile and pharmacokinetic analyses of the anti-CTLA4 antibody tremelimumab administered as a one hour infusion. J Transl Med. 2012 Nov 21;10:236. doi: 10.1186/1479-5876-10-236.
PubMed 23171508
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, Open Label, Single Arm Study To Establish The Safety Of Administering CP 675,206 As A One Hour Infusion In Patients With Surgically Incurable Stage III Or Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00585000
- Acronym / sponsor ID
- A3671022
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Jan 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.
This will show if CP-675,206 can be administered safely as an intravenous infusion lasting one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.
Detailed description
This study was prematurely discontinued on April 28, 2008 because a concomitant Phase 3 study met pre-specified futility criteria. The decision to close enrollment early was not based on any safety concerns.
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: CP-675,206 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed melanoma that is surgically incurable Note: Prior therapies for melanoma, including cancer vaccines, are permitted but are not required. There is no limit to the number of prior regimens for melanoma a patient may have received.
- Evidence of at least one lesion
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- CT scan of the brain with contrast or MRI of the brain within 6 weeks prior to enrollment showing no evidence of active brain metastases. PET scans and PET/CT scans are also acceptable.
Key exclusion criteria (5 listed)
- Previous treatment with other anti CTLA4 agents (eg, ipilimumab, MDX 010).
- Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of CP 675,206 and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma.
- History of chronic autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, etc.).
- History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT scan only.
- Brain metastases that have not been adequately treated with surgery or stereotactic radiosurgery and have not been stable at least 3 months prior to enrollment.
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-675,20615 mg/kg. IV (in the vein) over 1 hour on Day 1 of each 90 day cycle. Number of cycles: maximum of 4 cycles unless progression of disease or unacceptable toxicity. | Drug | 1 |
Primary outcome
To assess safety and tolerability during and for 1 hour following a 15 mg/kg dose of CP 675,206 administered as a one hour infusion.
Time frame: Last patient dosed = 31Dec2009
5 secondary outcomes
To monitor for human anti human (HAHA) response to CP 675,206
Time frame: Last HAHA time point obtain =estimated 31Dec2009
To assess evidence of anti tumor activity as measured by best overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) criteria, duration of response, progression free survival
Time frame: Last RECIST obtained = estimated 31Dec2009
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of subjects treated with CP 675,206
Time frame: Last PG obtained = estimated 31Dec2009
To evaluate the overall safety and tolerability of CP 675,206 in this population
Time frame: Last patient dosed = estimated 31Dec2009
To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion
Time frame: Last PK timepoint obtained =estiamted 31Dec2009
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- Derived from this study: PubMed 23171508Ribas A, Chesney JA, Gordon MS, Abernethy AP, Logan TF, Lawson DH, Chmielowksi B, Glaspy JA, Lewis K, Huang B, Wang E, Hsyu PH, Gomez-Navarro J, Gerhardt D, Marshall MA, Gonzalez R. Safety profile and pharmacokinetic analyses of the anti-CTLA4 antibody tremelimumab administered as a one hour infusion. J Transl Med. 2012 Nov 21;10:236. doi: 10.1186/1479-5876-10-236.
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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 4 inclusion and 5 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: stopped early, 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 was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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 safety and tolerability during and for 1 hour following a 15 mg/kg dose of CP 675,206 administered as a one hour infusion. (time frame: Last patient dosed = 31Dec2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00585000, which also lists 1 linked publication.
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.