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A Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study

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 : November 25, 2019
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 after they have completed the duration of treatment and all protocol-specified assessments and procedures in a previous Spectrum-sponsored poziotinib study (Original Study). Patients will proceed to the study with a maximum hiatus of 20 days following the End-of-Treatment (EOT) visit in the Original Study.

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 EOT visit of the Original Study. The assessments obtained at the EOS visit will serve as Baseline data for the extension study. If a patient in the Original Study was to undergo an EOT visit and an EOS visit with no treatment administered between these two assessments, the patient, if consented to this Extension Study must enroll right after (with a maximum hiatus of 20 days) the EOT Visit of the Original Study so that the treatment will continue without a break.

Patients will continue to receive poziotinib treatment at the dose and regimen they were receiving at the end of the Original Study.

Patients may receive treatment until disease progression or as long as the patient is deriving clinical benefit, as judged by the investigator (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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Extension Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study
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 same as the dose at the end of the Original Study unless modified. If a dose is missed, it may be taken any time during the day preferably with food, 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 participated in and completed all protocol-specified assessments for a Spectrum-sponsored clinical Study with poziotinib.
  • Patient must have completed the End of Treatment or End of Study visit of the original Spectrum-sponsored Study.
  • Patient did not meet any treatment discontinuation criteria other than completing maximum treatment time of the original Spectrum-sponsored Study.
  • Investigator 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 as defined in the original clinical study protocol.
  • 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 could impact 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 is receiving any other treatment modalities with curative intent for his or her malignancy, including investigational products other than poziotinib. Therapies to palliate local symptoms will be allowed (e.g. radiation for focal bone metastasis).
  • Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the investigator.
  • 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: Bill Paxton, MD 949-743-9259 Bill.Paxton@sppirx.com

Locations
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United States, Mississippi
Hattiesburg Clinic Hematology Oncology Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Tammy McBeth    601-288-2495      
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: November 25, 2019
Last Verified: November 2019
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