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Cytotoxic Agent

Poziotinib for Non-Small Cell Lung Cancer (PINNACLE Trial)

Phase 3
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 up to approximately 5 years
Awards & highlights

PINNACLE Trial Summary

This trial will compare the effects of two drugs on lung cancer patients with HER2 exon 20 mutations.

Eligible Conditions
  • Non-Small Cell Lung Cancer

PINNACLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Overall survival (OS)

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%
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

PINNACLE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Poziotinib 8 mgExperimental Treatment1 Intervention
Participants will receive poziotinib 8 mg, orally, BID, in 21 day cycles or until disease progression, death, intolerable adverse events (AEs), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons for participant withdrawal from the study.
Group II: Docetaxel 75 mg/m^2Active Control1 Intervention
Participants will receive docetaxel 75 mg/m^2, intravenously (IV) on Day 1 of each 21-day treatment cycle or until disease progression, death, intolerable AEs, initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons for participant withdrawal from the study.
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
7,921 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up to participate in this research project?

"Yes. The most recent information available on clinicaltrials.gov indicates that this trial is still recruiting patients. This study was first posted on May 12th, 2022 and received its latest update June 10th of the same year. There is space for 268 participants at a single location."

Answered by AI

Are investigators looking for more participants?

"Yes, this trial is currently open for enrolment according to the website clinicaltrials.gov. The listing was first put up on May 12th, 2022 and edited most recently on June 10th of the same year."

Answered by AI

Do we know of any adverse effects to taking Poziotinib?

"Poziotinib's safety is estimated to be a 3. This judgement comes from the fact that Poziotinib is in Phase 3 trials, which suggests that not only does some data support efficacy, but multiple rounds of testing have been conducted to support safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
2022. "A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378763.
~176 spots leftby Dec 2027
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