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Tyrosine Kinase Inhibitor
Poziotinib for Advanced Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Yasir Y Elamin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically or cytologically confirmed stage IV or recurrent solid tumor not amenable to curative intent therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying how well poziotinib works to treat patients with non-small lung cancer that has an EGFR or HER2 exon 20 mutation and is stage IV or has come back (recurrent). Poziotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that has specific mutations (EGFR or HER2 exon 20). Participants must have tried all standard treatments, be able to swallow pills, and not be pregnant. They should also have adequate organ function and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Poziotinib, a drug designed to block enzymes that promote tumor growth in patients with certain genetic mutations in their lung cancer cells. It's a phase II study which means it focuses on the drug's efficacy and side effects.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include issues related to blocking enzymes needed for cell growth such as fatigue, skin reactions, digestive problems, liver enzyme changes, and possibly an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is at stage IV or recurrent and cannot be cured with surgery or other treatments.
Select...
My NSCLC has a HER2 exon 20 mutation.
Select...
I have enough tumor tissue from a biopsy or surgery for testing.
Select...
I am not pregnant and agree to use birth control during and 6 months after the study.
Select...
I am a man who can father children and will use birth control during and 90 days after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate a in patients with estimated glomerular filtration rate (EGFR) exon 20 mutant non-small Cell Lung Cancer (NSCLC) (Cohort 1)
Objective response rate a in patients with human epidermal growth factor receptor 2 (HER2) exon 20 mutant non-small Cell Lung Cancer (NSCLC) (Cohort 2)
Secondary outcome measures
Disease control rate (complete response + partial response + stable disease) of poziotinb in cohort 1 and 2, analyzed independently
Duration of response of poziotinb in cohort 1 and 2, analyzed independently
Incidence of adverse events
+2 moreSide effects data
From 2020 Phase 2 trial • 67 Patients • NCT0265951491%
Diarrhoea
61%
Rash
55%
Fatigue
48%
Stomatitis
48%
Vomiting
39%
Decreased Appetite
36%
Nausea
33%
Dry skin
24%
Mucosal inflammation
24%
Dermatitis acneiform
21%
Urinary tract infection
21%
Hypokalaemia
18%
Weight decreased
18%
Alopecia
18%
Dizziness
15%
Dehydration
15%
Anaemia
15%
Constipation
15%
Headache
15%
Epistaxis
12%
Pyrexia
12%
Oedema peripheral
12%
Pain
12%
Paronychia
12%
Blood creatinine increased
12%
Aspartate aminotransferase increased
12%
Musculoskeletal pain
12%
Arthralgia
12%
Anxiety
12%
Cough
12%
Dyspnoea
12%
Oropharyngeal pain
9%
Conjunctivitis
9%
Blood alkaline phosphatase increased
9%
Blood potassium decreased
9%
Alanine aminotransferase increased
9%
Hypomagnesaemia
9%
Dysgeusia
9%
Burning sensation
9%
Agitation
9%
Pleural effusion
9%
Rash maculo-papular
9%
Pruritus
6%
Pericardial effusion
6%
Rhinorrhoea
6%
Eye discharge
6%
Hypertension
6%
Thrombocytopenia
6%
Dry eye
6%
Dry mouth
6%
Abdominal distension
6%
Cheilitis
6%
Chills
6%
Fungal infection
6%
Vulvovaginal mycotic infection
6%
Blood uric acid increased
6%
Hyponatraemia
6%
Muscular weakness
6%
Myalgia
6%
Somnolence
6%
Urinary incontinence
6%
Vulvovaginal discomfort
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Erythema
6%
Pruritus generalised
6%
Rash macular
6%
Skin lesion
6%
Abdominal pain upper
6%
Asthenia
6%
Cellulitis
6%
Dysuria
3%
Eye irritation
3%
Nasal dryness
3%
Ophthalmic herpes zoster
3%
Sinusitis
3%
Ocular hyperaemia
3%
Tinea pedis
3%
Dysphonia
3%
Sinus congestion
3%
Hiccups
3%
Upper respiratory tract infection
3%
Cataract
3%
Blood urea increased
3%
Oral pain
3%
Platelet count decreased
3%
Skin irritation
3%
Dermatitis bullous
3%
Rash generalised
3%
Acute respiratory failure
3%
Vitreous floaters
3%
Oral discomfort
3%
Gastritis
3%
Gingival pain
3%
Glossodynia
3%
Candida infection
3%
Skin candida
3%
Neuropathy peripheral
3%
Lymphopenia
3%
Oral candidiasis
3%
Ear pain
3%
Hypothyroidism
3%
Soft tissue infection
3%
Eye swelling
3%
Flatulence
3%
Gastrooesophageal reflux disease
3%
Proctalgia
3%
Dysphagia
3%
Cardio-respiratory arrest
3%
Lip oedema
3%
Mouth ulceration
3%
Influenza like illness
3%
Oedema
3%
Gait disturbance
3%
Multiple organ dysfunction syndrome
3%
Herpes zoster
3%
Rash pustular
3%
Pneumonia
3%
Femur fracture
3%
Haemorrhage intracranial
3%
Spinal cord compression
3%
Syncope
3%
Respiratory failure
3%
Fall
3%
Nail injury
3%
Procedural pain
3%
Scapula fracture
3%
Blood magnesium decreased
3%
Lymphocyte count decreased
3%
White blood cell count increased
3%
Neutrophil count increased
3%
Blood bilirubin increased
3%
Blood calcium decreased
3%
Glomerular filtration rate decreased
3%
Glomerular filtration rate increased
3%
Haematocrit decreased
3%
Haemoglobin decreased
3%
Liver function test abnormal
3%
Neutrophil count decreased
3%
Hypophosphataemia
3%
Hypercalcaemia
3%
Acidosis
3%
Hyperphosphataemia
3%
Balance disorder
3%
Depression
3%
Insomnia
3%
Delirium
3%
Irritability
3%
Breast pain
3%
Vulvovaginal inflammation
3%
Perineal pain
3%
Vulvovaginal burning sensation
3%
Nasal congestion
3%
Paranasal sinus discomfort
3%
Pleuritic pain
3%
Respiratory tract congestion
3%
Throat irritation
3%
Rash erythematous
3%
Skin disorder
3%
Urticaria
3%
Skin lesion excision
3%
Hypotension
3%
Lymphoedema
3%
Angular cheilitis
3%
Cystitis
3%
Ear infection
3%
Localised infection
3%
Back pain
3%
Musculoskeletal chest pain
3%
Bone pain
3%
Musculoskeletal stiffness
3%
Pain in extremity
3%
Breast cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Poziotinib 24 mg
Cohort 2: Poziotinib 16 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (poziotinib)Experimental Treatment1 Intervention
Patients receive poziotinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poziotinib
2016
Completed Phase 2
~340
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,665 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,037 Total Patients Enrolled
Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,073 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My solid tumor, not lung cancer, has EGFR or HER2 mutations.I have tried all standard treatments for my advanced cancer or cannot receive them.You have a disease that can be measured using a specific medical guideline.I am fully active or restricted in physically strenuous activity but can do light work.I am not using effective birth control.I have a condition that causes me to bleed easily.My cancer has a specific EGFR mutation.I haven't taken any experimental drugs or cancer treatments in the last 2 weeks.I am not currently on any cancer treatments like chemotherapy.Your kidneys are working well enough to filter out waste from your body.I have not had major surgery in the last 4 weeks, except for procedures to place a vascular access device.My NSCLC has a HER2 exon 20 mutation.I am allergic to poziotinib or similar medications.I don't have lasting side effects from cancer treatment, except for hair loss.I can swallow pills.You have a low level of white blood cells.Your absolute neutrophil count is at least 1,500 per microliter.Your platelet count is at least 100,000 per microliter.I have enough tumor tissue from a biopsy or surgery for testing.I am not pregnant and agree to use birth control during and 6 months after the study.I am a woman who meets the specific age requirements.I am a man who can father children and will use birth control during and 90 days after the study.My brain or spinal metastases are stable, treated, and I haven't needed more medication for them in the last 4 weeks.I cannot take pills by mouth due to stomach or intestinal problems.I do not have any severe illnesses that would stop me from following the study's requirements.My cancer is at stage IV or recurrent and cannot be cured with surgery or other treatments.I haven't had any cancer other than skin or cervical cancer in the last 2 years.My NSCLC has a specific EGFR exon 20 mutation.My solid tumor has a HER2 exon 19 mutation.My liver function tests are within the required range.Your alkaline phosphatase level is not higher than the normal range for the hospital, or if you have liver metastases, it is not more than 5 times the normal range.My brain metastases are stable and don't need increasing steroids or seizure meds.I have a heart condition.My NSCLC has a specific EGFR exon 20 mutation, not including T790M.Your total bilirubin level is less than or equal to two times the upper limit of normal.I don't have any health issues that could make the treatment unsafe for me.Your hemoglobin level is at least 9.0 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (poziotinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people total will be taking part in this clinical trial?
"The listing on clinicaltrials.gov verifies that this trial is open for enrollment and has been since 3/17/2017. The study needs 80 patients from a single site."
Answered by AI
Does this research project explore uncharted territory?
"5 different clinical trials for Poziotinib are active as of now, spanning 9 countries and 49 cities. The first trial began in 2017 and was sponsored by Spectrum Pharmaceuticals, Inc. That initial study involved 80 patients and completed Phase 2 drug approval in 2017. In the 4 years since that study's completion, 11 more trials have wrapped up."
Answered by AI
Are researchers actively working to enroll more participants for this clinical trial?
"Yes, as of right now this clinical trial is still recruiting patients. The study was originally posted on March 17th, 2017 and the most recent update was June 24th, 20212. They are looking for 80 individuals to participate at 1 site."
Answered by AI
What are the goals that researchers hope to achieve with this study?
"The primary outcome that will be measured over the course of 4 years is Objective response rate in patients with human epidermal growth factor receptor 2 (HER2) exon 20 mutant non-small cell lung cancer (NSCLC) who are treated with poziotinib. Additionally, this trial will assess secondary outcomes including Duration of response and Progression free survival which will both be analyzed independently."
Answered by AI
What is the research history of Poziotinib?
"There are 5 ongoing studies and 0 completed Phase 3 trials for Poziotinib. Currently, the majority of clinical trials for Poziotinib are being conducted in Shreveport, Louisiana; however, there are a total of 73 locations running these sorts of investigations."
Answered by AI
When will Poziotinib be available for public use?
"Poziotinib's safety was given a score of 2 because, while there is some data supporting its safety, there is none yet demonstrating its efficacy."
Answered by AI
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