ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03804515
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: 14C-labeled poziotinib Phase 1

Detailed Description:

This is a Phase 1, open-label, single-dose study of 14C-labeled poziotinib 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.

On Day 1, enrolled patients will be admitted to the inpatient unit and all predose assessments will be completed. Patients will be admitted to the inpatient unit for 9 days. On Day 2, a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally in the morning right after breakfast with at least 200 mL of water.

Over the following 168 hours, urine and feces will be collected and pooled at specified intervals for measurement of total radioactivity recovered and subsequent determination of the routes of elimination of poziotinib and its metabolites. Blood samples will be taken at specified time points for 168 hours after dosing for estimation of single-dose poziotinib PK parameters.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: 14C-labeled Poziotinib Drug: 14C-labeled poziotinib
a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally




Primary Outcome Measures :
  1. Maximum recovery of the radioactive dose in plasma, urine and feces [ Time Frame: 1 year ]
    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 Outcome Measures :
  1. The concentration of 14C-labeled poziotinib and its metabolites in plasma, urine and feces [ Time Frame: 1 year ]
    To identify major metabolites of poziotinib



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804515


Contacts
Contact: Shanta Chawla, MD 949-743-9218 shanta.chawla@sppirx.com
Contact: Helen Vu 949-743-9395 helen.vu@sppirx.com

Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03804515     History of Changes
Other Study ID Numbers: SPI-POZ-102
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spectrum Pharmaceuticals, Inc:
EGFR
HER2 mutations
EGFR/HER2 overexpression/amplification