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Tyrosine Kinase Inhibitor
Poziotinib for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Spectrum Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it's effective and safe. It includes 7 groups of patients with different types of lung cancer, and will last for 603 patients.
Who is the study for?
This trial is for NSCLC patients with specific mutations (EGFR or HER2 exon 20). It includes those who've had prior treatments and treatment-naïve individuals. Participants must have advanced or metastatic cancer, not curable by surgery or radiation, and good organ function. Pregnant women, breastfeeding mothers, and those treated with similar drugs are excluded.Check my eligibility
What is being tested?
The study tests Poziotinib's effectiveness and safety in various patient groups based on their treatment history and genetic mutation type. This Phase 2 trial involves multiple centers where participants receive the drug to see how well it works against lung cancer.See study design
What are the potential side effects?
While the exact side effects aren't listed here, typical ones for drugs like Poziotinib may include diarrhea, skin issues, fatigue, liver enzyme changes, and potential heart problems. Each person's experience can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Other outcome measures
Progression-free Survival (PFS) - Exploratory
Side 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%
Tinea pedis
3%
Nasal dryness
3%
Ophthalmic herpes zoster
3%
Sinusitis
3%
Ocular hyperaemia
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: PoziotinibExperimental Treatment1 Intervention
Cohort 1: Previously treated participants with EGFR exon 20 insertion mutant positive NSCLC (closed to enrollment)
Cohort 2: Previously treated participants with HER2 exon 20 insertion mutant positive NSCLC (closed to enrollment)
Cohort 3: Treatment naïve participants with EGFR exon 20 insertion-mutant positive NSCLC (fully enrolled)
Cohort 4: Treatment naïve participants with HER2 exon 20 insertion mutant positive NSCLC
Cohort 5: Participants who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed
Cohort 6: Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib
Cohort 7: Participants with EGFR or HER2 activating mutations
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?
Spectrum Pharmaceuticals, IncLead Sponsor
82 Previous Clinical Trials
7,541 Total Patients Enrolled
Lyndah Dreiling, MDStudy DirectorSpectrum Pharmaceuticals, Inc
5 Previous Clinical Trials
285 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received at least one treatment for advanced lung cancer.You have a specific mutation called EGFR exon 20 insertion.If you are in Cohorts 3 or 4, you have not received treatment before for advanced lung cancer and you can take poziotinib as your first treatment. Any previous treatments must have ended at least 15 days before the study starts.You have taken a specific type of medication for your condition before joining the study. The currently approved medications are allowed, but others are not.In cohorts 2 and 4, you have a confirmed HER2 exon 20 insertion mutation.You have specific mutations in your EGFR or HER2 genes.You have had any other types of cancer in the past 3 years, except for certain skin, prostate, cervix, or breast conditions that have been treated and are stable.You are currently receiving certain cancer treatments, or have recently received them, and may not be eligible if you have had other treatments recently.You have advanced or spreading non-small cell lung cancer that cannot be treated with the intent of curing it.For Cohort 6: Patients with a specific type of lung cancer who got worse while taking a drug called osimertinib as their first treatment.You have received treatment before for advanced lung cancer.You have received treatment before for advanced lung cancer.For Cohort 5: You have documented mutations in the EGFR or HER2 genes.For Cohort 6: You have a specific mutation in the EGFR gene that was found after treatment with osimertinib.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
Non-Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT03318939 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this the pioneering trial of its kind?
"Since its first clinical trial in 2017, sponsored by Spectrum Pharmaceuticals, Inc. and involving 80 participants, Poziotinib has been thoroughly studied with 5 current trials running across 49 cities and 9 nations. Subsequent to the initial study it was granted Phase 2 drug approval."
Answered by AI
What is the aggregate size of the cohort engaged in this medical experiment?
"In order to conduct the study, 603 suitable participants must be enrolled. The sponsor, Spectrum Pharmaceuticals Inc., will undertake recruitment at multiple sites such as North Shore Hematology Oncology Associates DBA New york Cancer and Blood Specialists in Bronx, New York and Virginia Cancer Specialists PC in Fairfax, Virginia."
Answered by AI
How many sites are currently carrying out this research?
"North Shore Hematology Oncology Associates DBA New york Cancer and Blood Specialists in Bronx, NY, Virginia Cancer Specialists PC in Fairfax, VA and Kaiser Permanente Medical Center in Vallejo, CA are among the 40 different medical sites running this trial."
Answered by AI
Are there any vacancies in this medical experiment for participants?
"Indeed, clinicaltrials.gov asserts that this medical initiative is actively seeking participants after first being posted on October 13th 2017 and most recently edited in February 24th 2022. 603 persons are required across 39 different locations to take part in the study."
Answered by AI
Has Poziotinib been sanctioned by the U.S. Food and Drug Administration?
"Poziotinib's safety, which has been partially verified by clinical data from a Phase 2 trial, is assigned an approximate score of 2."
Answered by AI
Are any other tests being conducted to assess the efficacy of Poziotinib?
"Poziotinib was initially studied in 2017 at the M D Anderson Cancer Center, and 11 studies have been successfully concluded since then. In addition to these completed trials, there are currently 5 active clinical trials with a significant number of them being conducted near Bronx, New york."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Oncology Physician's Network Inc./OPN Healthcare
UCSF Helen Diller Comprehensive Cancer Center at Mt Zion
Kaiser Permanente Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Wanted to support and help the trial.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is the prescreening take?
PatientReceived 2+ prior treatments
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