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

NCT03804515 | Terminated Phase 1 FDA Drug

• 1 other identifier: SPI-POZ-102
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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/amplification.

Conditions

Solid Tumor

Keywords

EGFR; HER2 mutations; EGFR/HER2 overexpression/amplification

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Secondary Outcomes (1)

• The concentration of 14C-labeled poziotinib and its metabolites in plasma, urine and feces

  1 year

Study Arms (1)

14C-labeled Poziotinib

EXPERIMENTAL

Drug: 14C-labeled poziotinib

Interventions

14C-labeled poziotinib DRUG

a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally

14C-labeled Poziotinib

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: June 25, 2019
• Primary Completion: February 20, 2020
• Study Completion: June 17, 2020
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

US (1)