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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
Must not have
Male or female patients of reproductive potential who are not employing an adequate method of birth control
Active bleeding disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is at stage IV or recurrent and cannot be cured with surgery or other treatments.
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My NSCLC has a HER2 exon 20 mutation.
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I have enough tumor tissue from a biopsy or surgery for testing.
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I am not pregnant and agree to use birth control during and 6 months after the study.
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I am a man who can father children and will use birth control during and 90 days after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not using effective birth control.
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I have a condition that causes me to bleed easily.
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My cancer has a specific EGFR mutation.
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I am not currently on any cancer treatments like chemotherapy.
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I cannot take pills by mouth due to stomach or intestinal problems.
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I do not have any severe illnesses that would stop me from following the study's requirements.
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I am allergic to poziotinib or similar medications.
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I don't have lasting side effects from cancer treatment, except for hair loss.
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I have a heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more

Side effects data

From 2020 Phase 2 trial • 67 Patients • NCT02659514
91%
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%
Eye discharge
6%
Rhinorrhoea
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%
Cataract
3%
Eye irritation
3%
Ocular hyperaemia
3%
Tinea pedis
3%
Upper respiratory tract infection
3%
Ophthalmic herpes zoster
3%
Sinusitis
3%
Nasal dryness
3%
Sinus congestion
3%
Dysphonia
3%
Hiccups
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,066 Previous Clinical Trials
1,802,152 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,908 Total Patients Enrolled
Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,082 Total Patients Enrolled

Media Library

Poziotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03066206 — Phase 2
EGFR Gene Mutation Research Study Groups: Treatment (poziotinib)
EGFR Gene Mutation Clinical Trial 2023: Poziotinib Highlights & Side Effects. Trial Name: NCT03066206 — Phase 2
Poziotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03066206 — Phase 2
~12 spots leftby Dec 2025
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