A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
Stopped early · Phase 1
Conditions studied: Solid Tumor
In brief
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/amplification.
Key facts
- Study ID
- NCT03804515
- Run by
- Spectrum Pharmaceuticals, Inc
- People needed
- 2
- Starts
- 2019-06-25
- Expected to finish
- 2020-06-17
- Last updated by the study team
- 2021-06-15
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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