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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00729833 |
The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.
Condition | Intervention | Phase |
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Advanced Cancer Advanced Solid Tumors |
Drug: CP-751,871 Drug: Sunitinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase 1, Open Label, Sequential Cohort, Dose Escalation Study of CP-751,871 in Combination With Sunitinib in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 45 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CP-751,871 + Sunitinib: Experimental
Escalating cohorts of CP-751,871 + Sunitinib
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Drug: CP-751,871
CP-751,871 IV, every 3 weeks
Drug: Sunitinib
Sunitinib - daily dosing
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: EmergingMed | (877) 369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, California | |
Pfizer Investigational Site | Recruiting |
Santa Monica, California, United States, 90404 | |
United States, Pennsylvania | |
Pfizer Investigational Site | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Texas | |
Pfizer Investigational Site | Recruiting |
San Antonio, Texas, United States, 78229 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4021024 |
Study First Received: | July 30, 2008 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00729833 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sunitinib Angiogenesis Inhibitors |
Antineoplastic Agents Sunitinib Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |