A Phase I Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies
Pazopanib has shown a promising anti-cancer activity as a single agent tyrosine kinase
inhibitor. Activity against multiple tumors such as renal cell carcinoma (RCC) and
neuroendocrine tumors have been documented, and it recently gained FDA approval for the
treatment of metastatic kidney cancer. Also, an impressive activity as a single agent was
recently reported in non-small cell lung cancer (NSCLC) in the neoadjuvant setting, where
tumor shrinkage occurred in 86% of patients. Encouraging activity has also been seen in
cervical cancer, ovarian cancer and soft tissue sarcomas. Multi-kinase targeting is an
approach that may prove beneficial in a number of patient populations. In particular cancers
such as breast, colon, pancreas etc., patients represent heterogeneous population of small
groups based on genetic analyses. Some of these populations may benefit when multiple agents
are given which have similar, but distinct targets of action. Dosages and therefore
associated toxicities might be reduced by such an approach.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of Pazopanib when used in combination with Carboplatin
Patients will receive 200mg of Pazopanib, with later subjects receiving higher dosages up to 800mg of Pazopanib. If a given dose level is not well tolerated when given on all days (1-21) of each cycle, the study will no longer use that dosage. Later subjects may take Pazopanib from days 3-19 of the three week cycle to see if that dosing schedule is better tolerated. If patients experience side effects from Pazopanib or tests indicate some undesirable effects, then the dose level of Pazopanib that they are receiving may need to be adjusted, with increased monitoring.
3 months
Yes
Montasur Shaheen, MD
Principal Investigator
New Mexico Cancer Care Alliance/UNMCC
United States: Food and Drug Administration
INST 1015
NCT01542047
August 2012
August 2017
Name | Location |
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University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |