A Phase 2 interventional study of Poziotinib in NSCLC, sponsored by Spectrum Pharmaceuticals, Inc. Terminated at 63 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Spectrum Pharmaceuticals, Inc (part of Zydus Lifesciences Limited) · Phase 2, Interventional, and Treatment
This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).
The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Participant must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible participants will provide written Informed Consent prior to undergoing any study procedures.
Each treatment cycle is 28 calendar days in duration. There will be seven participant cohorts and eligible participants will be enrolled into each cohort in parallel based on epidermal growth factor receptor (EGFR) or human epidermal growth factor receptor 2 (HER2) exon 20 mutation status and prior treatment status:
Toxicity will be assessed based on the grade of the adverse events using CTCAE version 4.03.
On Day 1 of each 28-day cycle, the participant's absolute neutrophil count (ANC) must be ≥1.5×10\^9/L and platelet count must be ≥100×10\^9/L before administering poziotinib. All participants will be treated until disease progression (except for first progression in Cohort 5), death, intolerable adverse events (AEs), or other protocol-specified reasons for participant withdrawal.
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.
Key Inclusion Criteria:
Prior treatment status:
Specific mutations:
Key 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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants previously treated for epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) received poziotinib, 16 milligrams (mg), orally, once daily (QD) in each 28-day cycle until disease progression, death, intolerable adverse events (AEs), or for up to a maximum of 35 months, whichever occurs first.
Drug: Poziotinib
Participants previously treated for human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
Drug: Poziotinib
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
Drug: Poziotinib
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, twice daily (BID) in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
Drug: Poziotinib
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
Drug: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
Drug: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
Drug: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
Drug: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
Drug: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
Drug: Poziotinib
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
Drug: Poziotinib
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
Drug: Poziotinib
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
Drug: Poziotinib
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
Drug: Poziotinib
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present.
Time frame: Up to 3 years
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occur from the first dose of study treatment until 35 (±5) days after the last dose of study treatment.
Time frame: Up to 5 years
Disease Control Rate (DCR)
DCR was defined as percentage of participants with best response of CR, PR, or stable disease (SD) from the first dose of poziotinib to the last tumor assessment on study. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. SD was defined as neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Time frame: Up to 3 years
Duration of Response (DoR)
DoR was evaluated only for participants who had CR or PR and was defined as the time from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. Disease progression was defined as greater than or equal to (≥) 20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline, if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Time frame: Up to 3 years
Progression-free Survival (PFS) - Exploratory
PFS was defined as the time (in months) from the treatment start date to the first date of documented PD or death. Disease progression was defined as ≥20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Time frame: Up to 3 years
Participants were enrolled at 62 investigative sites from 11 October 2017 to 03 April 2023.
| Milestone | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 115 | 90 | 80 | 33 | 47 | 38 | 125 | 35 | 25 | 26 | 7 | 1 | 17 | 9 |
| Completed | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 114 | 90 | 78 | 33 | 46 | 38 | 125 | 35 | 25 | 26 | 7 | 1 | 17 | 9 |
| Withdrew: Adverse event | 16 | 13 | 9 | 3 | 1 | 3 | 16 | 5 | 3 | 1 | 0 | 0 | 2 | 1 |
| Withdrew: Initiation of non-protocol therapy | 3 | 1 | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Disease progression | 61 | 53 | 51 | 21 | 30 | 24 | 56 | 22 | 12 | 14 | 6 | 1 | 5 | 8 |
| Withdrew: Withdrawal by subject | 14 | 5 | 8 | 1 | 4 | 3 | 12 | 4 | 3 | 6 | 0 | 0 | 1 | 0 |
| Withdrew: Delay of poziotinib administration for more than 28 days since last administration | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 1 | 0 |
| Withdrew: Investigator decision | 4 | 0 | 1 | 0 | 1 | 1 | 6 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Sponsor decision | 0 | 0 | 0 | 5 | 0 | 3 | 12 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 14 | 10 | 7 | 1 | 5 | 3 | 7 | 2 | 4 | 2 | 0 | 0 | 4 | 0 |
| Withdrew: Reason not specified | 2 | 4 | 1 | 1 | 2 | 1 | 14 | 1 | 2 | 1 | 0 | 0 | 1 | 0 |
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present.
| percentage of participants | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib | Cohort 5: Poziotinib | Cohort 6: Poziotinib | Cohort 7: Poziotinib |
|---|---|---|---|---|---|---|---|
| Objective Response Rate (ORR) | 13.9 (8.2 to 21.6) | 27.8 (18.9 to 38.2) | 0 (0 to 0) | 39 (28 to 50) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occur from the first dose of study treatment until 35 (±5) days after the last dose of study treatment.
| Participants | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 115 | 90 | 80 | 33 | 47 | 37 | 124 | 35 | 25 | 26 | 6 | 1 | 17 | 9 |
DCR was defined as percentage of participants with best response of CR, PR, or stable disease (SD) from the first dose of poziotinib to the last tumor assessment on study. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. SD was defined as neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
| percentage of participants | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib | Cohort 5: Poziotinib | Cohort 6: Poziotinib | Cohort 7: Poziotinib |
|---|---|---|---|---|---|---|---|
| Disease Control Rate (DCR) | 67.8 (58.5 to 76.2) | 70 (59.4 to 79.2) | 0 (0 to 0) | 73 (61 to 82) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
DoR was evaluated only for participants who had CR or PR and was defined as the time from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. Disease progression was defined as greater than or equal to (≥) 20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline, if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
| months | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib | Cohort 5: Poziotinib | Cohort 6: Poziotinib | Cohort 7: Poziotinib |
|---|---|---|---|---|---|---|---|
| Duration of Response (DoR) | 6.5 (3.3 to 8.2) | 5.1 (4.2 to 5.5) | — | 5.7 (4.6 to 11.9) | — | — | — |
PFS was defined as the time (in months) from the treatment start date to the first date of documented PD or death. Disease progression was defined as ≥20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Results for this outcome have not been posted.
Collected over Up to 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Poziotinib 16 mg | 16/115 (13.9%) | 50/115 (43.5%) | 115/115 (100%) |
| Cohort 2: Poziotinib 16 mg | 16/90 (17.8%) | 36/90 (40%) | 90/90 (100%) |
| Cohort 3: Poziotinib, 16 mg | 14/80 (17.5%) | 35/80 (43.8%) | 80/80 (100%) |
| Cohort 4: Poziotinib 8 mg | 6/33 (18.2%) | 12/33 (36.4%) | 33/33 (100%) |
| Cohort 4: Poziotinib 16 mg | 8/47 (17%) | 18/47 (38.3%) | 47/47 (100%) |
| Cohort 5: Poziotinib 6 mg | 11/38 (28.9%) | 13/38 (34.2%) | 37/38 (97.4%) |
| Cohort 5: Poziotinib 8mg | 24/125 (19.2%) | 38/125 (30.4%) | 124/125 (99.2%) |
| Cohort 5: Poziotinib 10 mg | 7/35 (20%) | 10/35 (28.6%) | 35/35 (100%) |
| Cohort 5: Poziotinib 12 mg | 14/25 (56%) | 14/25 (56%) | 25/25 (100%) |
| Cohort 5: Poziotinib 16 mg | 4/26 (15.4%) | 12/26 (46.2%) | 26/26 (100%) |
| Cohort 6: Poziotinib 8 mg | 1/7 (14.3%) | 1/7 (14.3%) | 6/7 (85.7%) |
| Cohort 6: Poziotinib 16 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Cohort 7: Poziotinib 8 mg | 6/17 (35.3%) | 9/17 (52.9%) | 17/17 (100%) |
| Cohort 7: Poziotinib 16 mg | 5/9 (55.6%) | 3/9 (33.3%) | 9/9 (100%) |
| Event | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib, 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SepsisInfections and infestations | 2/115 | 0/90 | 2/80 | 0/33 | 0/47 | 0/38 | 0/125 | 0/35 | 0/25 | 1/26 | 1/7 | 0/1 | 0/17 | 0/9 |
| VomitingGastrointestinal disorders | 1/115 | 0/90 | 4/80 | 0/33 | 1/47 | 0/38 | 0/125 | 2/35 | 1/25 | 1/26 | 1/7 | 0/1 | 1/17 | 0/9 |
| FatigueGeneral disorders | 0/115 | 2/90 | 0/80 | 0/33 | 0/47 | 0/38 | 1/125 | 0/35 | 1/25 | 0/26 | 1/7 | 0/1 | 0/17 | 0/9 |
| Abdominal pain upperGastrointestinal disorders | 0/115 | 0/90 | 0/80 | 0/33 | 0/47 | 0/38 | 0/125 | 0/35 | 0/25 | 0/26 | 1/7 | 0/1 | 0/17 | 0/9 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 4/115 | 0/90 | 3/80 | 1/33 | 1/47 | 0/38 | 1/125 | 1/35 | 0/25 | 0/26 | 0/7 | 0/1 | 2/17 | 0/9 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/115 | 4/90 | 4/80 | 0/33 | 0/47 | 0/38 | 0/125 | 1/35 | 1/25 | 0/26 | 0/7 | 0/1 | 0/17 | 1/9 |
| Urinary tract infectionInfections and infestations | 0/115 | 0/90 | 0/80 | 1/33 | 1/47 | 0/38 | 0/125 | 0/35 | 0/25 | 0/26 | 0/7 | 0/1 | 0/17 | 1/9 |
| Acute myocardial infarctionCardiac disorders | 0/115 | 0/90 | 0/80 | 0/33 | 1/47 | 0/38 | 0/125 | 0/35 | 0/25 | 0/26 | 0/7 | 0/1 | 0/17 | 1/9 |
| Decreased appetiteMetabolism and nutrition disorders | 1/115 | 0/90 | 3/80 | 0/33 | 0/47 | 0/38 | 0/125 | 0/35 | 0/25 | 0/26 | 0/7 | 0/1 | 0/17 | 1/9 |
| Decubitus ulcerSkin and subcutaneous tissue disorders | 0/115 | 0/90 | 0/80 | 0/33 | 0/47 | 0/38 | 0/125 | 0/35 | 0/25 | 0/26 | 0/7 | 0/1 | 0/17 | 1/9 |
| Event | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib, 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 94/115 | 75/90 | 70/80 | 29/33 | 39/47 | 32/38 | 111/125 | 29/35 | 22/25 | 22/26 | 5/7 | 0/1 | 17/17 | 7/9 |
| RashSkin and subcutaneous tissue disorders | 71/115 | 62/90 | 51/80 | 17/33 | 35/47 | 24/38 | 75/125 | 24/35 | 21/25 | 16/26 | 2/7 | 1/1 | 7/17 | 6/9 |
| StomatitisGastrointestinal disorders | 83/115 | 60/90 | 64/80 | 24/33 | 38/47 | 26/38 | 96/125 | 23/35 | 18/25 | 13/26 | 5/7 | 0/1 | 10/17 | 6/9 |
| ParonychiaInfections and infestations | 57/115 | 38/90 | 53/80 | 21/33 | 24/47 | 17/38 | 60/125 | 16/35 | 18/25 | 12/26 | 1/7 | 0/1 | 3/17 | 2/9 |
| FatigueGeneral disorders | 40/115 | 29/90 | 35/80 | 18/33 | 17/47 | 15/38 | 61/125 | 8/35 | 14/25 | 5/26 | 2/7 | 0/1 | 7/17 | 1/9 |
| Decreased appetiteMetabolism and nutrition disorders | 43/115 | 36/90 | 33/80 | 18/33 | 15/47 | 7/38 | 57/125 | 7/35 | 6/25 | 7/26 | 1/7 | 0/1 | 6/17 | 3/9 |
| NauseaGastrointestinal disorders | 56/115 | 35/90 | 33/80 | 14/33 | 13/47 | 7/38 | 45/125 | 11/35 | 7/25 | 7/26 | 1/7 | 0/1 | 6/17 | 0/9 |
| PruritusSkin and subcutaneous tissue disorders | 30/115 | 24/90 | 22/80 | 10/33 | 9/47 | 9/38 | 0/125 | 8/35 | 12/25 | 5/26 | 1/7 | 0/1 | 4/17 | 2/9 |
| Dry skinSkin and subcutaneous tissue disorders | 34/115 | 30/90 | 34/80 | 11/33 | 17/47 | 13/38 | 38/125 | 13/35 | 9/25 | 11/26 | 2/7 | 0/1 | 4/17 | 1/9 |
| AlopeciaSkin and subcutaneous tissue disorders | 35/115 | 32/90 | 30/80 | 14/33 | 18/47 | 0/38 | 36/125 | 7/35 | 7/25 | 6/26 | 1/7 | 0/1 | 3/17 | 1/9 |
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
| Age, Continuous(years) | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 60.2 ± 12.38 | 60.0 ± 11.69 | 59.9 ± 10.44 | 59.6 ± 13.82 | 61.4 ± 12.18 | 59.5 ± 14.65 | 65.0 ± 9.91 | 63.5 ± 10.82 | 62.6 ± 9.95 | 63.6 ± 8.31 | 55.7 ± 10.90 | 34.0 ± NA | 63.0 ± 11.35 | 61.3 ± 6.14 | 59.9 ± 5.59 |
| Sex: Female, Male(Participants) | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 77 | 58 | 45 | 16 | 25 | 23 | 85 | 26 | 19 | 19 | 5 | 1 | 15 | 4 | 418 |
| Male | 38 | 32 | 35 | 17 | 22 | 15 | 40 | 9 | 6 | 7 | 2 | 0 | 2 | 5 | 230 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 0 | 0 | 3 | 3 | 2 | 2 | 1 | 2 | 0 | 0 | 0 | 0 | 23 |
| Not Hispanic or Latino | 110 | 85 | 80 | 33 | 44 | 35 | 123 | 33 | 24 | 24 | 7 | 1 | 17 | 9 | 625 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: Poziotinib 16 mg | Cohort 2: Poziotinib 16 mg | Cohort 3: Poziotinib 16 mg | Cohort 4: Poziotinib 8 mg | Cohort 4: Poziotinib 16 mg | Cohort 5: Poziotinib 6 mg | Cohort 5: Poziotinib 8mg | Cohort 5: Poziotinib 10 mg | Cohort 5: Poziotinib 12 mg | Cohort 5: Poziotinib 16 mg | Cohort 6: Poziotinib 8 mg | Cohort 6: Poziotinib 16 mg | Cohort 7: Poziotinib 8 mg | Cohort 7: Poziotinib 16 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Asian | 18 | 12 | 15 | 4 | 7 | 3 | 17 | 2 | 0 | 2 | 3 | 0 | 5 | 0 | 88 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Black or African American | 12 | 4 | 1 | 1 | 3 | 5 | 12 | 3 | 3 | 0 | 0 | 0 | 1 | 1 | 46 |
| White | 77 | 70 | 61 | 27 | 35 | 28 | 90 | 27 | 21 | 21 | 4 | 1 | 11 | 8 | 481 |
| Other | 7 | 3 | 2 | 1 | 2 | 2 | 6 | 2 | 1 | 3 | 0 | 0 | 0 | 0 | 29 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Apr 2023, 65 months.
Results were first posted in Jun 2026, 3 years 2 months after primary completion. A results delay was requested in Apr 2024.
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Studies of the drug tested here: Poziotinib
Spectrum Pharmaceuticals, Inc →