A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
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|ClinicalTrials.gov Identifier: NCT03804515|
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: 14C-labeled poziotinib||Phase 1|
This is a Phase 1, open-label, single-dose study of 14C-labeled poziotinib to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.
On Day 1, enrolled patients will be admitted to the inpatient unit and all predose assessments will be completed. Patients will be admitted to the inpatient unit for 9 days. On Day 2, a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally in the morning right after breakfast with at least 200 mL of water.
Over the following 168 hours, urine and feces will be collected and pooled at specified intervals for measurement of total radioactivity recovered and subsequent determination of the routes of elimination of poziotinib and its metabolites. Blood samples will be taken at specified time points for 168 hours after dosing for estimation of single-dose poziotinib PK parameters.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
|Experimental: 14C-labeled Poziotinib||
Drug: 14C-labeled poziotinib
a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally
- Maximum recovery of the radioactive dose in plasma, urine and feces [ Time Frame: 1 year ]The route of excretion of radioactive poziotinib and its metabolites following single oral administration of 14C-labeled poziotinib in patients with solid tumors suitable for treatment with poziotinib.
- The concentration of 14C-labeled poziotinib and its metabolites in plasma, urine and feces [ Time Frame: 1 year ]To identify major metabolites of poziotinib
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): NCT03804515
|Contact: Shanta Chawla, MDfirstname.lastname@example.org|
|Contact: Helen Vuemail@example.com|