Clinical trial · Interventional
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
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
NCT03804515CI-TRIAL-00052278terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): COVID
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 14C-labeled poziotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 14C-labeled Poziotinib
- interventionNames
- Drug: 14C-labeled poziotinib
Primary outcomes (1)
- measure
- Maximum recovery of the radioactive dose in plasma, urine and feces
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (1)
- measure
- The concentration of 14C-labeled poziotinib and its metabolites in plasma, urine and feces
- timeFrame
- 1 year
- description
- To identify major metabolites of poziotinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.