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A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to 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: NCT03744715
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:

This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment who have had previous exposure to poziotinib and/or are still receiving clinical benefit from treatment, as judged by the Investigator or treating physician. Patients must begin treatment in this study within 28 days after their last dose of poziotinib.

This extension protocol is intended to provide clinical benefit of poziotinib to patients who are responding to treatment. The additional treatment is optional and voluntary.


Condition or disease Intervention/treatment Phase
NSCLC Breast Cancer Drug: Poziotinib Phase 2

Detailed Description:

Patients who wish to participate in the extension study must provide written Informed Consent. Treatment will begin after completion of the End of Study (EOS) or End of Treatment (EOT) visit of the Original Study. The assessments obtained at the EOS or EOT visit will serve as Baseline data for the extension study.

Patients will continue to receive poziotinib treatment at the last dose received or at the standard starting dose of 16 milligrams (mg) poziotinib, once daily.

Patients may receive treatment as long as the patient is deriving clinical benefit, as judged by the investigator or treating physician (case-by-case decision with approval of Spectrum), death, withdrawal of consent, unacceptable toxicity, lost to follow-up, or poziotinib receives commercial approval in their country of residence or development is terminated by the Sponsor, whichever occurs first. There will be an EOS Visit 35 (±5) days after the last dose of poziotinib.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : October 5, 2023
Estimated Study Completion Date : April 5, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Poziotinib
Poziotinib
Drug: Poziotinib
Poziotinib will be taken by the patient orally, once daily with food and a glass of water at approximately the same time. The dose will be the last dose received or at the standard starting dose of 16 mg poziotinib. If a dose is missed, it may be taken any time during the day preferably with food, but at least 8 hours prior to the next scheduled dose.




Primary Outcome Measures :
  1. Number of patients with serious adverse events [ Time Frame: 24 months ]
    Number of patients with serious adverse events



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has had previous exposure to poziotinib and is still receiving clinical benefit from treatment, as judged by the Investigator or treating physician.
  • Patient must have completed the End of Treatment or End of Study visit if enrolled in a previous (original) poziotinib study.
  • Investigator or treating physician opinion indicates that extended therapy with poziotinib is clinically appropriate for the patient and the patient is suitable for this Study.
  • Patient agrees to continue study treatment.
  • Patient must provide written Informed Consent, must be able to adhere to dosing and visit schedules, and meet protocol-defined study requirements.
  • Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of poziotinib.

Exclusion Criteria:

  • Patient has any ongoing adverse event that hasn't improved to Grade ≤1 and could impact the patient's tolerability to poziotinib.
  • Patient has an active uncontrolled infection, bleeding disorder, underlying medical condition, or other serious illness that would impair the ability of the patient to receive poziotinib.
  • Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the investigator or treating physician.
  • Patient last dose of poziotinib was more than 28 days prior to Day 1 of the study.
  • Patient is pregnant or breastfeeding.

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): NCT03744715


Contacts
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Contact: Lyndah Dreiling, MD 949-788-6700 lyndah.dreiling@sppirx.com

Locations
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United States, California
Pacific Shores Medical Group Recruiting
Long Beach, California, United States, 90813
United States, Mississippi
Hattiesburg Clinic Hematology Oncology Completed
Hattiesburg, Mississippi, United States, 39401
United States, Pennsylvania
UPMC Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03744715    
Other Study ID Numbers: SPI-POZ-501
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Exon 20 insertion mutation
Poziotinib