Status:
TERMINATED
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Solid Tumor
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The purpose of this study is 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/amplifi...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03804515
Start Date
June 25 2019
End Date
June 17 2020
Last Update
June 15 2021
Active Locations (1)
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1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232