Study of High-dose, Intermittent Sunitinib in Patients With Solid Tumors.
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|ClinicalTrials.gov Identifier: NCT02058901|
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : July 17, 2019
The primary objective of this study is:
- To determine the maximum tolerated dose (MTD) of sunitinib when administered once weekly or once every two weeks.
- To assess the safety and tolerability of sunitinib in a once weekly or once every two weeks dose schedule.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Sunitinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of High-dose, Intermittent Sunitinib in Patients With Solid Tumors.|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
Experimental: Sunitinib high dose, weekly schedule
Initial dose of sunitinib is set at 200 mg once weekly. Three patients are treated at the current dose level. If at least 2 patients are observed to have Dose Limiting Toxicity (DLT), the prior dose level is defined as the Maximum Tolerated Dose (MTD) (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 patients are observed to have DLT, the dose level is escalated one step for the next cohort of 3 patients. If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level. If none of these show DLT, the dose level is escalated for the next cohort of 3 patients; otherwise, the prior dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). A tentative MTD becomes final when a total of 6 patients are treated with less than 2 showing DLT
Experimental: Sunitinib high dose, biweekly schedule
When the final MTD is reached for the cohort of patients treated once weekly and depending on the toxicities developed and defining MTD, enrollment of patients in the once every 2 weeks escalation cohort will begin, with the initial dose set at the MTD dose of the once weekly schedule, escalating again at 100 mg increments per dose level.
- maximum tolerated dose (MTD) of sunitinib [ Time Frame: 6 weeks ]
- Number of participants with serious and non-serious adverse events [ Time Frame: 6 weeks ]
- Calculation of maximum plasma drug concentration, sunitinib half life, Area Under the Concentration-Time Curve (AUC 0-48h), clearance and volume of distribution [ Time Frame: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 24, and 48 hours post-dose ]
- Time to Disease Progression [ Time Frame: end of study ]
- Recommended phase II dose (RP2D) and the optimal dose schedule [ Time Frame: End of study ]
- Measurement of intratumoral and skin concentration of sunitinib [ Time Frame: 2 weeks ]
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): NCT02058901
|VU University Medical Center|
|Amsterdam, Netherlands, 1081HV|
|Principal Investigator:||Henk MW Verheul, MD, PhD||VU University Medical Center|