A Phase 2 interventional study of Poziotinib in NSCLC and Breast Cancer, sponsored by Spectrum Pharmaceuticals, Inc. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Spectrum Pharmaceuticals, Inc (part of Zydus Lifesciences Limited) · Phase 2, Interventional, and Treatment
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 7 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Spectrum Pharmaceuticals, Inc is the lead sponsor of 60 studies on the registry; 1 is open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 12 (67%) have results posted.
First submitted before Spectrum Pharmaceuticals, Inc became part of Zydus Lifesciences Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Poziotinib
Poziotinib
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Up to 18 months
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time frame: Up to 17 months
Disease Control Rate (DCR)
DCR is defined as percentage of participants with best response of CR, PR, and stable disease (SD) from the first dose of poziotinib to the end of study. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Time frame: Up to 17 months
Duration of Response (DOR)
Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Time frame: Up to 17 months
Progression Free Survival (PFS)
PFS was the duration of time from first administration of study treatment to date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Time frame: Up to 17 months
Participants were enrolled at investigative sites across the United States from 11 October 2018 to 03 March 2023.
| Milestone | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg |
|---|---|---|---|---|---|---|
| Started | 1 | 1 | 1 | 1 | 2 | 1 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 1 | 1 | 1 | 2 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Disease progression | 0 | 1 | 0 | 0 | 1 | 1 |
| Withdrew: Study terminated by sponsor | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Initiation of another anti-malignancy therapy | 0 | 0 | 1 | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
| Participants | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg |
|---|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | 1 | 1 | 1 | 1 | 2 | 1 |
ORR was defined as the percentage of participants with confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
No measurements were reported for this outcome.
DCR is defined as percentage of participants with best response of CR, PR, and stable disease (SD) from the first dose of poziotinib to the end of study. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
No measurements were reported for this outcome.
Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
No measurements were reported for this outcome.
PFS was the duration of time from first administration of study treatment to date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
No measurements were reported for this outcome.
Collected over Up to 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Poziotinib 6 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Poziotinib 8 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Poziotinib 12 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Poziotinib 14 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Poziotinib 16 mg | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Poziotinib 24 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg |
|---|---|---|---|---|---|---|
| NephrolithiasisRenal and urinary disorders | 0/1 | 0/1 | 0/1 | 0/1 | 1/2 | 0/1 |
| PancreatitisGastrointestinal disorders | 0/1 | 0/1 | 0/1 | 0/1 | 1/2 | 0/1 |
| DehydrationMetabolism and nutrition disorders | 0/1 | 0/1 | 0/1 | 0/1 | 1/2 | 0/1 |
| AscitesGastrointestinal disorders | 0/1 | 0/1 | 0/1 | 0/1 | 1/2 | 0/1 |
| Event | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg |
|---|---|---|---|---|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 0/1 | 1/1 | 0/1 | 0/1 | 2/2 | 0/1 |
| AnaemiaBlood and lymphatic system disorders | 0/1 | 0/1 | 1/1 | 0/1 | 1/2 | 0/1 |
| FatigueGeneral disorders | 0/1 | 0/1 | 0/1 | 0/1 | 2/2 | 0/1 |
| RashSkin and subcutaneous tissue disorders | 0/1 | 1/1 | 0/1 | 0/1 | 2/2 | 0/1 |
| VomitingGastrointestinal disorders | 0/1 | 0/1 | 1/1 | 0/1 | 1/2 | 0/1 |
| DiarrhoeaGastrointestinal disorders | 0/1 | 1/1 | 1/1 | 1/1 | 1/2 | 0/1 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/1 | 0/1 | 0/1 | 0/1 | 2/2 | 0/1 |
| ParonychiaInfections and infestations | 0/1 | 1/1 | 1/1 | 1/1 | 1/2 | 0/1 |
| HeadacheNervous system disorders | 0/1 | 0/1 | 0/1 | 0/1 | 0/2 | 1/1 |
| Vision blurredEye disorders | 0/1 | 0/1 | 0/1 | 0/1 | 0/2 | 1/1 |
Analysis population included all participants who had previous exposure to poziotinib.
| Age, Categorical(Participants) | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 | 1 | 2 | 1 | 4 |
| >=65 years | 1 | 1 | 1 | 0 | 0 | 0 | 3 |
| Sex: Female, Male(Participants) | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 1 | 0 | 1 | 1 | 4 |
| Male | 1 | 0 | 0 | 1 | 1 | 0 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 1 | 1 | 2 | 1 | 7 |
| Race (NIH/OMB)(Participants) | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 1 | 1 | 0 | 0 | 4 |
| Region of Enrollment(Participants) | Poziotinib 6 mg | Poziotinib 8 mg | Poziotinib 12 mg | Poziotinib 14 mg | Poziotinib 16 mg | Poziotinib 24 mg | Total |
|---|---|---|---|---|---|---|---|
| United States | 1 | 1 | 1 | 1 | 2 | 1 | 7 |
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Studies of the drug tested here: Poziotinib
Spectrum Pharmaceuticals, Inc →