Poziotinib for Non-Small Cell Lung Cancer

Roswell Park Cancer Institute, Buffalo, NY
Non-Small Cell Lung CancerPoziotinib - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Live microbiome therapeutic
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ABTL0812

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 24 months

24 months
Disease Control Rate (DCR)
Duration of Response (DoR)
Objective Response Rate (ORR)
Progression-free Survival (PFS) - Exploratory

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
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1
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Side Effects for

Cohort 1: Poziotinib 24 mg
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%Dizziness
18%Alopecia
15%Anaemia
15%Constipation
15%Headache
15%Epistaxis
15%Dehydration
12%Aspartate aminotransferase increased
12%Blood creatinine increased
12%Pyrexia
12%Oedema peripheral
12%Pain
12%Paronychia
12%Arthralgia
12%Anxiety
12%Cough
12%Dyspnoea
12%Oropharyngeal pain
12%Musculoskeletal pain
9%Conjunctivitis
9%Blood alkaline phosphatase increased
9%Blood potassium decreased
9%Alanine aminotransferase increased
9%Dysgeusia
9%Burning sensation
9%Agitation
9%Pleural effusion
9%Rash maculo-papular
9%Pruritus
9%Hypomagnesaemia
6%Dysuria
6%Dry eye
6%Dry mouth
6%Abdominal pain upper
6%Cheilitis
6%Asthenia
6%Chills
6%Fungal infection
6%Cellulitis
6%Blood uric acid increased
6%Muscular weakness
6%Somnolence
6%Urinary incontinence
6%Vulvovaginal discomfort
6%Rhinorrhoea
6%Palmar-plantar erythrodysaesthesia syndrome
6%Erythema
6%Pruritus generalised
6%Rash macular
6%Hypertension
6%Vulvovaginal mycotic infection
6%Thrombocytopenia
6%Eye discharge
6%Pericardial effusion
6%Abdominal distension
6%Myalgia
6%Hyponatraemia
6%Skin lesion
3%Mouth ulceration
3%Skin disorder
3%Glossodynia
3%Scapula fracture
3%Gingival pain
3%Urticaria
3%Lymphocyte count decreased
3%Cardio-respiratory arrest
3%Pneumonia
3%Soft tissue infection
3%Femur fracture
3%Spinal cord compression
3%Ear pain
3%Hypothyroidism
3%Eye irritation
3%Ocular hyperaemia
3%Vitreous floaters
3%Flatulence
3%Gastrooesophageal reflux disease
3%Oral discomfort
3%Oral pain
3%Dysphagia
3%Gastritis
3%Influenza like illness
3%Oedema
3%Gait disturbance
3%Multiple organ dysfunction syndrome
3%Herpes zoster
3%Rash pustular
3%Candida infection
3%Tinea pedis
3%Upper respiratory tract infection
3%Angular cheilitis
3%Cystitis
3%Ear infection
3%Localised infection
3%Ophthalmic herpes zoster
3%Oral candidiasis
3%Sinusitis
3%Skin candida
3%Fall
3%Nail injury
3%Procedural pain
3%Blood magnesium decreased
3%White blood cell count increased
3%Neutrophil count increased
3%Platelet count decreased
3%Blood bilirubin increased
3%Blood calcium decreased
3%Blood urea increased
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%Back pain
3%Breast cancer
3%Syncope
3%Balance disorder
3%Neuropathy peripheral
3%Depression
3%Insomnia
3%Delirium
3%Irritability
3%Breast pain
3%Vulvovaginal inflammation
3%Perineal pain
3%Vulvovaginal burning sensation
3%Nasal dryness
3%Sinus congestion
3%Dysphonia
3%Hiccups
3%Nasal congestion
3%Paranasal sinus discomfort
3%Pleuritic pain
3%Respiratory tract congestion
3%Throat irritation
3%Skin irritation
3%Dermatitis bullous
3%Rash erythematous
3%Rash generalised
3%Skin lesion excision
3%Hypotension
3%Lymphoedema
3%Lip oedema
3%Proctalgia
3%Acute respiratory failure
3%Haemorrhage intracranial
3%Respiratory failure
3%Eye swelling
3%Lymphopenia
3%Cataract
3%Musculoskeletal chest pain
3%Hyperphosphataemia
3%Acidosis
3%Bone pain
3%Musculoskeletal stiffness
3%Hypercalcaemia
3%Pain in extremity
3%Hypophosphataemia
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02659514) in the Cohort 1: Poziotinib 24 mg ARM group. Side effects include: Diarrhoea with 91%, Rash with 61%, Fatigue with 55%, Stomatitis with 48%, Vomiting with 48%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Poziotinib
1 of 1

Experimental Treatment

603 Total Participants · 1 Treatment Group

Primary Treatment: Poziotinib · No Placebo Group · Phase 2

Poziotinib
Drug
Experimental Group · 1 Intervention: Poziotinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poziotinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Spectrum Pharmaceuticals, IncLead Sponsor
82 Previous Clinical Trials
7,615 Total Patients Enrolled
Lyndah Dreiling, MDStudy DirectorSpectrum Pharmaceuticals, Inc
5 Previous Clinical Trials
319 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received at least one form of treatment before for your advanced or metastatic NSCLC.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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