A Phase 1 interventional study of CP-675,206 and SU011248 in Carcinoma, Renal Cell, sponsored by AstraZeneca. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-06.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 28 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: CP-675,206 · Drug: SU011248
Drug: CP-675,206 · Drug: SU011248
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
SU011248 administered at a dose of 37.5mg/day every day.
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
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
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
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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