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 : Terminated (COVID)
First Posted : January 15, 2019
Last Update Posted : June 15, 2021
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|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)|
|Actual Enrollment :||2 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|
|Actual Study Start Date :||June 25, 2019|
|Actual Primary Completion Date :||February 20, 2020|
|Actual Study Completion Date :||June 17, 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
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|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient can be male or female and is at least 18 years of age
- Patient must be willing and capable of giving written Informed Consent and willing to stay in the research unit for 9 days.
- Patient has a life expectancy of at least 6 months.
- Histological confirmation of solid tumor cancer that is suitable for poziotinib therapy. These may include patients with any solid malignancy with either EGFR or HER 2 mutations or EGFR/HER2 overexpression/amplification. Brain metastases are allowed, if patient is clinically stable and does not require treatment with anticonvulsants or escalating steroid doses.
- Patient has a diagnosis of primary and or metastatic hepatic or renal carcinomas.
- Patient is unable to take oral medication or has ongoing Grade ≥2 diarrhea due to any etiology including Crohn's disease and/or ulcerative colitis.
- Previous poziotinib exposure
- Patient has previously participated in a study utilizing 14C.
- Patient has any pathology or history of procedures expected to change absorption
- Patient has a PEG (Percutaneous Endoscopic Gastrostomy) tube
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
|United States, Pennsylvania|
|UPMC Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Responsible Party:||Spectrum Pharmaceuticals, Inc|
|Other Study ID Numbers:||
|First Posted:||January 15, 2019 Key Record Dates|
|Last Update Posted:||June 15, 2021|
|Last Verified:||June 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|