A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies
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|ClinicalTrials.gov Identifier: NCT01542047|
Recruitment Status : Terminated (Low rate of accrual)
First Posted : March 1, 2012
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer, Metastatic||Drug: Carboplatin Drug: Pazopanib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies|
|Study Start Date :||August 2012|
|Primary Completion Date :||February 2013|
|Study Completion Date :||July 2013|
Experimental: Carboplatin AUC5 + escalating pazopanib
Carboplatin AUC5 IV Day 1 Pazopanib in escalating dosages, 200 mg to 800 mg starting on days 2 or 3 and ending on days 19 or 21
Carboplatin will be administered intravenously over approximately 30 minutes on day 1 of each cycle. The dosage used will be 5 AUC for the first 5 cycles, and will be increased to 6 AUC for the sixth cycle.
Other Names:Drug: Pazopanib
Pazopanib will be administered orally at 200 to 800 mg/kg2. It will be given either on days 1 through 21 of each 3-week cycle, or if needed, it will be given on days 3 through 19.
Other Name: Votrient
- Maximum tolerated dose of Pazopanib when used in combination with Carboplatin [ Time Frame: 3 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542047
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131-0001|
|Principal Investigator:||Montasur Shaheen, MD||New Mexico Cancer Care Alliance/UNMCC|