A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib

• Status: Terminated
• Trial end date: 2020-06-17
• Target enrollment: 0
• Participant gender: All

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/amplification.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc

Criteria

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