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MelanomaPhase 1NCT05810740

Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations

A Phase 1 study testing Binimetinib 15 MG and Binimetinib 45 MG in people with Melanoma and BRAF V600 Mutation, run by Pierre Fabre Medicament at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration. For the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended dosing regimen is 45 mg twice daily (bis in die… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Binimetinib 15 MG and Binimetinib 45 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteFrance
Study dates
31 Aug 2022to 18 Jan 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All the following inclusion criteria had to be met for a participant to be eligible to be included in this study:
  • Provide a signed and dated ICF.
  • Healthy participant. Note: defined as an absence of clinically significant abnormalities and any active medical conditions, as identified by a detailed medical history, complete physical examination, vital signs, clinical laboratory tests, cardiac and ophthalmologic evaluation as assessed by the Investigator.
  • Male and female between ≥ 18 and ≤ 65 years of age (at the day of signature of consent).
  • Female participants had to be postmenopausal or sterilized. Note: due to preclinical data of teratogenicity and lack of data on human pregnancies with binimetinib, women of childbearing potential were excluded from this study.
  • Women were considered postmenopausal and not of childbearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL (except if treated with hormone replacement therapy [HRT]) or had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to dosing. In case of doubt on the menopausal status, the participant was not included. In the case of oophorectomy alone, the reproductive status of the woman was to be confirmed by a follow-up hormone level assessment to consider her of non-childbearing potential.
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  • Men with a female partner of childbearing potential were required to use an effective method of birth control or practice abstinence for the entire study duration and for up to 30 days following the last dose of the study treatment.
  • Note: the following birth control was recommended: condom for the male participant and an intrauterine device with spermicide or oral or implanted hormonal contraception for the female partner.
  • Body mass index (BMI) of ≥ 18.5 to < 30 kg/m2 with body weight ≥ 50 kg and < 100 kg.
  • Vital signs within the following ranges or if out of normal ranges, considered as not clinically significant by the Investigator except for high diastolic blood pressure (BP): (After at least 5 minutes rest in the supine position)
  • Supine systolic BP ≥ 90 mmHg and ≤ 140 mmHg
  • Supine diastolic BP ≥ 50 mmHg and ≤ 90 mmHg
  • Supine pulse rate (PR) ≥ 45 to ≤ 100 beats per minute (bpm)
  • Body temperature between ≥ 35.0°C and ≤ 37.5°C
  • Orthostatic hypotension had to be ruled out based on the following criteria after standing for 5 minutes:
  • More than a 20 mmHg decrease in systolic BP or 10 mmHg decrease in diastolic BP ii. Clinical signs/symptoms of postural hypotension (dizziness, syncope, etc.), regardless of vital signs.
  • Participants had to have safety laboratory values within the normal ranges or if out of normal ranges considered as not clinically significant by the Investigator except for the following parameters:
  • Total bilirubin ≤ upper limit of normal (ULN).
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT) ≤ ULN and alkaline phosphatase (ALP) ≤ 1.1 X ULN.
  • Serum creatinine within normal range, except on P1D-1 and P2D-1 (≤ 1.1 X ULN).
  • Serum amylase and lipase ≤ ULN.
  • Fasting glucose, coagulation panel (prothrombin ratio) within normal range and activated partial thromboplastin time (aPTT) ≤ 1.1 X ULN.
  • NB: It was to be noted that for the parameters acceptable at ≤ 1.1 X ULN, if more than one parameter exceeded ULN, the participant was excluded.
  • Able to communicate well with the Investigator and comply with the requirements of the study.
  • Participants had to be willing to comply with dietary and fluid restrictions (from D-7 to 72 hours after the last study treatment administration, see Section 9.4.7.3).
  • Willing to remain in the clinical research unit as required by the protocol.
  • Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.

Who cannot join

  • Participants meeting any of the following criteria were not eligible to be included in this study:
  • Concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with protocol.
  • Pregnant or currently breastfeeding women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
  • A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents, and siblings) of prolonged QT interval syndrome.
  • Impaired cardiovascular function.
  • Note: including any one of the following:
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  • Left ventricular ejection fraction (LVEF) < 50% or below the institutional lower limit of the normal range (whichever was higher) as determined by standard cardiac echocardiography
  • Inability to determine the QT interval on ECG
  • Complete left bundle branch block
  • Use of a ventricular-paced pacemaker
  • Congenital long QT syndrome
  • History of or presence of clinically significant ventricular or atrial tachyarrhythmia
  • Clinically significant resting bradycardia (< 40 bpm)
  • History of clinically documented myocardial infarction
  • History of angina pectoris
  • History of known structural abnormalities (i.e., cardiomyopathy)
  • Other clinically significant cardiovascular disease (e.g., congestive heart failure, atherosclerosis, labile hypertension, or uncontrolled hypertension)
  • Abnormal ECG defined as:
  • PR interval > 220 msec, QRS complex > 110 msec, QT interval corrected using Fridericia's method (QTcF) > 450 msec (male) and > 470 msec (female) ii. Any ST/T wave abnormalities iii. Any atrial or ventricular arrhythmias, which were of clinical significance and could have had an impact on the safety of the participant or the study as determined by the Investigator iv. Any cardiac conduction abnormalities
  • History of fainting spells or orthostatic hypotension episodes
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which might jeopardize the participant in case of participation in the study
  • Note: The Investigator was to be guided by evidence of any of the following:
  • History of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding
  • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, cholecystectomy or bowel resection
  • History of, or clinical evidence of, pancreatic injury or pancreatitis
  • Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, ALP, or serum bilirubin
  • Malabsorption syndrome
  • History of impaired renal function or elevated creatinine values indicating impaired renal function
  • Evidence of urinary tract obstruction or difficulty in voiding at screening
  • History of autonomic dysfunction or Gilbert syndrome
  • History of immunocompromised status, including a positive human immunodeficiency virus (HIV) infection (enzyme-linked immunosorbent assay and western blot) test result
  • A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or positive COVID-19 test result or other clinically relevant viral infections
  • Significant illness within the 2 weeks prior to dosing
  • History of clinically significant drug allergy
  • History of atopic allergy (asthma, urticaria, and eczematous dermatitis)
  • Use of any prescription drugs or over-the-counter (OTC) medications (except acetaminophen, i.e., paracetamol) and vitamins, supplements, and herbal remedies within 2 weeks prior to dosing
  • Participants taking acetaminophen (i.e., paracetamol) on a daily basis for more than 2 consecutive days within 1 week prior to dosing was not to be enrolled
  • History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO [e.g., optic disc cupping, visual field defects, intraocular pressure (IOP) > 21 mmHg]
  • Subfoveal choroidal thickness outside of 40μm - 475μm range
  • Neuromuscular disorders that were associated with elevated creatine kinase (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
  • Underwent major surgery ≤ 3 weeks prior to starting study treatment or who had not recovered from side effects of such a procedure
  • Known history or ongoing alcohol abuse within 4 weeks prior to dosing of study treatment Note: alcohol consumption was prohibited 1 week prior to dosing
  • Known regular use of recreational drugs within 4 weeks prior to dosing of study treatment Note: evidence of alcohol abuse/drug use (criterion No. 19 and including this criterion No. 20) as indicated by the laboratory tests conducted during screening or baseline evaluations
  • Smoker or use of tobacco products or products containing nicotine in the 4 weeks prior to first dosing of study treatment Note: smokers were defined as any participant who reported the use of a product containing nicotine during the preceding 30 days or had a positive urine cotinine test > 200 ng/mL
  • Medical, psychiatric, cognitive, or other conditions that could have compromised the participant's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
  • Malignancy with the following exceptions:
  • Adequately treated basal cell or squamous cell carcinoma of the skin (adequate wound healing was required prior to study entry)
  • Primary malignancy which had been completely resected and was in complete remission for ≥ 5 years
  • History of retinal degenerative disease
  • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation, or within seven half-lives of the investigational agent taken (whichever was longer) Note: participants who had taken part in a clinical investigation receiving any form of binimetinib had to have completed a 3-week washout prior to baseline
  • Donation or loss of 400 mL or more of blood within 4 weeks prior to dosing
  • Inability to swallow
  • Any vaccination within 4 weeks prior to dosing
  • Participant was under any administrative or legal supervision During the time window authorized for the screening visit (i.e., between 21 and 2 days before admission to the first treatment period), the Investigator could order a re-test of any parameter evaluated during the initial screening visit if he/she needed to evaluate the evolution of said parameter(s) or to confirm the value observed Rechecking of any parameter was to be limited to one time except when the measurement had not been obtained in accurate conditions.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Biotrial

    Rennes, 35000

Other trials in France

About this study

Official title: A Randomized, Single-center, Open-label, Single Dose, Two-period, Crossover Pivotal Bioequivalence Study Comparing Binimetinib 3 x 15 mg and 45 mg Tablets in Healthy Participants

The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration. For the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial formulation of 15 mg was demonstrated. In order to reduce the patient's burden, a new strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x 15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the bioequivalence between one 45 mg tablet and three 15 mg tablets is therefore required.

Read the detailed description

The reference (R) formulation is the currently commercially available tablet containing 15 mg of binimetinib as active substance, administered as three tablets for a total of 45 mg binimetinib. The Test (T) formulation is the tablet containing 45 mg of binimetinib as active substance in one tablet. Participants will be randomized to one of 2 treatment sequences (RT or TR) containing 2 treatment periods, with at least a 7-day washout between each dose.

The study will consist of a screening period between 21 and 2 days before the first study treatment administration on Period (P) 1 Day (D) 1, 2 treatment periods of 5 days each, and a washout of at least 7 days between P1D1 and P2D1.

Study treatments are given by the oral route in fasted condition. The end-of-study (EOS) visit will be performed 30 (± 3) days after the last study treatment administration or discontinuation.

Being tested
Binimetinib 15 MG, Binimetinib 45 MG
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Binimetinib 15 MGDrug

    Binimetinib 15 mg tablet

  • Binimetinib 45 MGDrug

    Binimetinib 45 mg tablet

Study groups in NCT05810740
Study groupRoleWhat they receive
Binimetinib 15 mg then Binimetinib 45 mgExperimentalParticipants first received a single dose of 3 tablets of Binimetinib 15 mg orally in fasted conditions in the morning on day 1 of a 5-day period. After a washout period of 7 days, they then received a single dose of 1 tablet of Binimetinib 45 mg orally in fasted conditions in the morning for five days on day 1 of a second 5-day period.
Receives: Drug: Binimetinib 15 MG; Drug: Binimetinib 45 MG
Binimetinib 45 mg then Binimetinib 15 mgExperimentalParticipants first received a single dose of 1 tablet of Binimetinib 45 mg orally in fasted conditions in the morning on day 1 of a 5-day period. After a washout period of 7 days, they then received a single dose of 3 tablets of Binimetinib 15 mg orally in fasted conditions in the morning for five days on day 1 of a second 5-day period.
Receives: Drug: Binimetinib 15 MG; Drug: Binimetinib 45 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Plasma Concentration-time Curve (AUC) From Time of Administration to Last Observed Plasma Concentration (AUClast) for Binimetinib

    The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUClast is defined as area under the concentration from zero to the last quantifiable plasma concentration.

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  2. AUC From Time of Administration to Infinity (AUCinf) for Binimetinib

    The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUCinf is defined as Area under the plasma concentration-time curve from time of administration to infinity

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  3. Maximum Observed Plasma Concentration (Cmax) for Binimetinib

    Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

Secondary outcomes (22)

  1. Time to Reach Cmax (Tmax) for Binimetinib

    Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  2. Terminal Half-life (t1/2) for Binimetinib

    The apparent terminal elimination half-life (t½) is defined as the time necessary for the concentration of a drug to decrease by one-half in the terminal phase

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  3. First Order Terminal Elimination Rate Constant (λz) of Binimetinib

    The first Order Terminal Elimination Rate Constant (λz) of Binimetinib corresponds to the rate at which a drug is removed from the human system

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  4. Residual Area (AUC_%Extrap_obs) for Binimetinib

    The residual area under the curve is expressed as a percentage of the total AUC extrapolated from tz to ∞, based on the area under the concentration-time curve.

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  5. Mean Residence Time (MRT) for Binimetinib

    Mean residence time (MRT) is defined as the average time for binimetinib to reside in the body

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  6. Area Under the Plasma Concentration-time Curve (AUC) From Time of Administration to Last Observed Plasma Concentration (AUClast) for AR00426032

    The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUClast is defined as area under the concentration from zero to the last quantifiable plasma concentration of AR00426032, a metabolite of binimetinib

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  7. AUC From Time of Administration to Infinity (AUCinf) for AR00426032

    The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUCinf is defined as Area under the plasma concentration-time curve from time of administration to infinity of AR00426032, a metabolite of binimetinib

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  8. Maximum Observed Plasma Concentration (Cmax) for AR00426032

    Cmax is referred as the maximum observed concentration of AR00426032 in blood plasma determined by bioanalysis

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  9. Time to Reach Cmax (Tmax) for AR00426032

    The timepoint at which the maximum concentration of AR00426032 is determined by bioanalysis in the blood plasma

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  10. Terminal Half-life (t1/2) for AR00426032

    The apparent terminal elimination half-life (t½) is defined as the time necessary for the concentration of a drug to decrease by one-half in the terminal phase

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  11. First Order Terminal Elimination Rate Constant (λz) of AR00426032

    The first Order Terminal Elimination Rate Constant (λz) of AR00426032 corresponds to the rate at which a drug is removed from the human system

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  12. Mean Residence Time (MRT) for AR00426032

    Mean residence time (MRT) is defined as the average time for AR00426032 to reside in the body

    Measured: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose

  13. Clinically Significant Changes From Baseline of Blood Hematology Parameters

    Clinically significant shift from baseline in blood hematology parameters (Erythrocytes (red blood cells, RBC), hematocrit, hemoglobin, platelets; leukocyte count with differential: basophils, eosinophils, lymphocytes, monocytes, neutrophils/absolute neutrophil count; RBC indices: mean corpuscular hemoglobin, mean corpuscular volume, reticulocytes/erythrocytes.)

    Measured: Blood samples for hematology parameters were taken at screening, on Day -1 of each period, at H24 and H48 post-dose of each period, and at end of study (EOS)

  14. Clinically Significant Changes From Baseline of Clinical Chemistry Parameters

    Clinically significant shift from baseline in clinical chemistry parameters (alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, gamma glutamyl transferase (GGT), indirect bilirubin, creatinine, urea, bicarbonate, calcium, chloride, magnesium, potassium, sodium, glucose, cholesterol, urate, albumin, creatine kinase (CK), lactate dehydrogenase, protein, amylase, and lipase)

    Measured: Blood samples for clinical chemistry parameters were taken at screening, on Day -1 of each period, at H24 and H48 post-dose of each period, and at EOS

  15. Clinically Significant Changes From Baseline of Coagulation Parameters

    Clinically significant shifts from baseline in coagulation parameters (activated partial thromboplastin time and prothrombin time)

    Measured: Blood samples for coagulation parameters were taken at screening, on Day -1 of each period, at H24 and H48 post-dose of each period, and at EOS

  16. Clinically Significant Changes From Baseline of Urinalysis Parameters

    Clinically significant changes from baseline in the quantitative assessment of pH, bilirubin, erythrocytes, glucose, ketones, leukocyte esterase, nitrite, protein, and urobilinogen

    Measured: Urinalysis samples were taken at screening, on Day -1 of each period, at H24 and H48 post-dose of each period, and at EOS

  17. Clinically Significant Abnormalities Values of Vital Sign Parameters

    Number of participants with at least one clinically significant vital signs abnormality. The following clinical signs were measured: supine and standing systolic and diastolic blood pressure (mmHg), pulse rate (beats/min) body temperature (°C), body weight, and BMI

    Measured: Vital signs were measured at screening, on Day -1 of each period, at Day 1 pre-dose, H24 and H72 post-dose of each period, and at EOS

  18. Clinically Significant Orthostatic Hypotension

    The number and percentage of participants with at least one orthostatic hypotension defined as standing systolic blood pressure (SBP) - supine SBP ≤ -20 mmHg or standing diastolic blood pressure (DBP) - supine DBP ≤ -10 mmHg considered clinically significant.

    Measured: Vital signs were measured at screening, on Day -1 of each period, at Day 1 pre-dose, H24 and H72 post-dose of each period, and at EOS

  19. Clinically Significant Abnormalities Values in 12-lead Electrocardiograms (ECG)

    Number of participant with at least one clinically significant electrocardiogram abnormality. The following standard 12-lead ECG parameters were recorded: heart rate (beats/min), PR interval (msec), QRS duration (msec), QRS axis (deg), QT interval (msec) and Fridericia QTc interval (msec)

    Measured: ECG abnormalities were recorded in triplicate at screening, on Day -1 of each period, at Day 1 pre-dose and H24 post-dose of each period, and at EOS

  20. Clinically Significant Physical Examination Abnormalities

    Number of participants with at least one clinically significant physical examination abnormality. A complete physical examination, including at minima assessments of the cardiovascular, dermatological, ear/nose/throat, eyes, gastrointestinal, general health/overall appearance, head, lymph, musculoskeletal, neck, neurological, and respiratory systems was performed

    Measured: A complete physical examination was performed at screening, on Day -1 of each period, at H24 post-dose of each period, and at EOS

  21. Abnormal Changes From Baseline in Visual Examinations

    Visual assessment was performed at screening, on Day -1 of each period, at H24 and H72 post-dose of each period, and at EOS

    Measured: A visual examination was performed at Screening at at EOS.

  22. Abnormal Changes From Baseline in Ophthalmologic Examinations

    Abnormal changes from baseline in ophthalmologic examinations including best corrected visual acuity for distance testing, optical coherence tomography and/or fluorescein angiography, slit lamp examination, IOP and dilated fundoscopy with attention to retinal abnormalities

    Measured: An opthalmologic examination was performed at Screening at at EOS.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2023
  2. Study start31 Aug 2022
  3. Primary completion22 Dec 2022
  4. Study completion18 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05810740
Sponsor's protocol ID
W00074CI103_1PF74
Status last verified
Sep 2023
First submitted
22 Jul 2022
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pierre Fabre will provide access to individual de-identified data and related study documents \[e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)\] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Binimetinib 15 MG and Binimetinib 45 MG in people with Melanoma and BRAF V600 Mutation, run by Pierre Fabre Medicament at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve (AUC) From Time of Administration to Last Observed Plasma Concentration (AUClast) for Binimetinib (time frame: Pre-dose = 0h and at 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05810740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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