TerminatedPhase 1

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

Stopped: COVID

United States2 participantsStarted 2019-06-25

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum recovery of the radioactive dose in plasma, urine and feces

Timeframe: 1 year

Trial details

NCT IDNCT03804515

SponsorSpectrum Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-20

View on ClinicalTrials.gov More Solid Tumor trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.