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Strategic business decision (unrelated to safety)
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This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
The Screening period (Day -30 to Day 1) begins 30 days prior to poziotinib treatment on Day 1 of Cycle 1. Patients must meet all Inclusion/Exclusion Criteria and provide informed written consent prior to study procedures.
The duration of each treatment cycle is 28 days. There will be five patient cohorts. Eligible patients will be enrolled into cohorts concurrently based on EGFR or HER2 exon 20 mutation status.
All patients will be treated daily for up to 24 months unless there is disease progression, death, intolerable adverse events (AEs), or another protocol-specified reason for patient withdrawal. After treatment discontinuation, patients will be contacted every 3 months for up to 2 years after the first dose of poziotinib to assess survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Patients with HER2-positive or HER2-negative BC with a HER2 activating mutation will receive poziotinib 8 milligrams (mg), orally, twice daily (BID) starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
|
| Cohort 2 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
|
| Cohort 3 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
|
| Cohort 4 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poziotinib Hydrochloride | Drug | The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective 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. | Up to 168 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (PD) 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. |
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Key Inclusion Criteria:
Patients must be at least 18 years old.
Patients must have histologic or cytologic evidence of a malignant solid cancer that is either advanced or metastatic there must be no available therapy known to confer a reasonable likelihood of clinical benefit.
Patients with BC must have a HER2 activating mutation determined by next-generation sequencing (NGS) performed on either tumor or plasma samples and:
Patients with microsatellite instability-high (MSI-H) CRC must have had appropriate checkpoint inhibitor-based therapy.
Patient's tumor must be positive for an EGFR or HER2 mutation based on DNA testing of either tumor tissue or plasma samples. Patients with documented EGFR or HER2 mutations may be identified by local testing from participating sites using next generation sequencing tests. Patient has a solid tumor with at least one of the listed activating mutations:
Patients must have measurable disease.
Patients with central nervous system (CNS) metastases must have stable CNS disease and no evidence of growth on imaging for at least 4 weeks following radiation or other locoregional ablative therapy. CNS symptoms must be stable with no requirement for anti-seizure medications and/or > 2 mg/day dexamethasone equivalent, except for patients with GBM (Cohort 4), in whom anti-seizure medications and/or up to 4 mg/day dexamethasone equivalent is allowed.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ -1.
Patients must have adequate hematopoietic, renal, and liver functions.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaba Kokhreidze, MD | Spectrum Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
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The participant was enrolled at 1 site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants with human epidermal growth factor receptor 2 (HER2) positive or HER2-negative breast cancer (BC) with a HER2 activating mutation were to receive poziotinib 8 milligrams (mg), orally, twice daily (BID) starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable adverse events (AEs), or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day according to treating physician's instructions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2021 |
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Each treatment cycle is 28 calendar days in duration. This is a basket study with five distinct cohorts. Eligible patients will be enrolled into the five cohorts concurrently based on tumor type and mutational status.
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|
| Cohort 5 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
|
| Loperamide | Drug | Loperamide as prescribed by the physician. |
|
| Up to 168 days |
| 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 PD, taking as reference the smallest sum of the longest diameter (LD) since the treatment started. | Up to 168 days |
| Percentage of Participants With AE | An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | Up to 30 days after last dose of study drug (Up to 199 days) |
| FG001 | Cohort 2 | Participants with colorectal cancer (CRC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| FG002 | Cohort 3 | Participants with solid tumors (except non-small cell lung cancer (NSCLC), BC, or CRC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| FG003 | Cohort 4 | Participants with glioblastoma (GBM) with epidermal growth factor receptor (EGFR) activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| FG004 | Cohort 5 | Participants with solid tumors (except NSCLC or GBM) with EGFR activating mutations were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| COMPLETED |
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| NOT COMPLETED |
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The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants with HER2-positive or HER2-negative BC with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day according to the treating physician's instructions. |
| BG001 | Cohort 2 | Participants with CRC with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| BG002 | Cohort 3 | Participants with solid tumors (except NSCLC, BC, or CRC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| BG003 | Cohort 4 | Participants with GBM with EGFR activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| BG004 | Cohort 5 | Participants with solid tumors (except NSCLC or GBM) with EGFR activating mutations were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective 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. | The Evaluable Population included all enrolled participants who completed at least 6 weeks of poziotinib treatment, had baseline and at least 1 post-baseline tumor response evaluation using RECIST, v1.1, or progressed prior to any post-baseline image evaluation. As the study was terminated early by the sponsor, there were no participants enrolled in cohorts 1-4. | Posted | Number | percentage of participants | Up to 168 days |
|
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| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 (PD) 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. | The Evaluable Population included all enrolled participants who completed at least 6 weeks of poziotinib treatment, had baseline and at least 1 post-baseline tumor response evaluation using RECIST, v1.1 or progressed prior to any post-baseline image evaluation. As the study was terminated early by the sponsor, there were no participants enrolled in cohorts 1-4. | Posted | Up to 168 days |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 PD, taking as reference the smallest sum of the longest diameter (LD) since the treatment started. | The Evaluable Population included all enrolled participants who completed at least 6 weeks of poziotinib treatment, had baseline and at least 1 post-baseline tumor response evaluation using RECIST, v1.1 or progressed prior to any post-baseline image evaluation. As the study was terminated early by the sponsor, there were no participants enrolled in cohorts 1-4. | Posted | Number | percentage of participants | Up to 168 days |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With AE | An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | The Safety Analysis Population included all enrolled patients who received at least 1 dose of poziotinib. As the study was terminated early by the sponsor, there were no participants enrolled in cohorts 1-4. | Posted | Number | percentage of participants | Up to 30 days after last dose of study drug (Up to 199 days) |
|
Up to 30 days after the last dose of study drug (Up to 199 days)
The Safety Analysis Population included all enrolled patients who received at least 1 dose of poziotinib. As the study was terminated early by the sponsor, there were no participants enrolled in cohorts 1-4.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Participants with HER2 positive or HER2-negative breast cancer (BC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable adverse events AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day according to treating physician's instructions. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Cohort 2 | Participants with CRC with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Cohort 3 | Participants with solid tumors (except NSCLC, BC, or CRC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Cohort 4 | Participants with GBM with EGFR activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Cohort 5 | Participants with solid tumors (except NSCLC or GBM) with EGFR activating mutations were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. | 0 | 1 | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Genital rash | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Paronychia | Infections and infestations | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sinus Tachycardia] | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Franklin, MD | Assertio Holdings | 224 419 7106 | Hfranklin@assertiotx.com |
| Feb 13, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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|
|
|
| Cohort 2 |
Participants with CRC with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG002 | Cohort 3 | Participants with solid tumors (except NSCLC, BC, or CRC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG003 | Cohort 4 | Participants with GBM with EGFR activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG004 | Cohort 5 | Participants with solid tumors (except NSCLC or GBM) with EGFR activating mutations were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
|
| Cohort 2 |
Participants with CRC with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG002 | Cohort 3 | Participants with solid tumors (except NSCLC, BC, or CRC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG003 | Cohort 4 | Participants with GBM with EGFR activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG004 | Cohort 5 | Participants with solid tumors (except NSCLC or GBM) with EGFR activating mutations were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
|
|
| OG002 | Cohort 3 | Participants with solid tumors (except non-small cell lung cancer (NSCLC), BC, or CRC) with a HER2 activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG003 | Cohort 4 | Participants with GBM with EGFR activating mutation were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
| OG004 | Cohort 5 | Participants with solid tumors (except NSCLC or GBM) with EGFR activating mutations were to receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28-day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Participants were also to receive loperamide 4 mg two to three times a day or according to the treating physician's instructions. |
|
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