Study Stopped
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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, 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
1 other identifier
interventional
49
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2007
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJune 6, 2012
June 1, 2012
2.1 years
December 21, 2007
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Last patient dosed = 31Dec2009
Secondary Outcomes (5)
To monitor for human anti human (HAHA) response to CP 675,206
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
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
Last PG obtained = estimated 31Dec2009
To evaluate the overall safety and tolerability of CP 675,206 in this population
Last patient dosed = estimated 31Dec2009
To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion
Last PK timepoint obtained =estiamted 31Dec2009
Study Arms (1)
1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
Los Angeles, California, 90095-7423, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Indianapolis, Indiana, 46202, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Durham, North Carolina, 27710, United States
Related Publications (1)
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.
PMID: 23171508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 2, 2008
Study Start
December 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
June 6, 2012
Record last verified: 2012-06