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Low-grade GliomaPhase 2PerfumeNCT06159478

Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

A Phase 2 study testing Binimetinib 15 MG in people with Low-grade Glioma and Pancreatic Cancer, run by National Cancer Center, Japan at 6 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusion/rearrangement. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Low-grade Glioma, Pancreatic Cancer
What is being tested?
Binimetinib 15 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
6 sitesJapan
Study dates
29 Mar 2023to 30 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • BRAF fusion or rearrangement is detected by reimbursed NGS-based cancer gene panel tests, cancer gene panel tests performed under advanced medical treatment, or clinical study (including liquid biopsy).
  • Unresectable or recurrent
  • No symptomatic brain metastasis, carcinomatous meningitis or spinal metastasis requiring surgical intervention or radiotherapy
  • No cardiac effusion, pleural effusion, or ascites requiring treatment
  • Not received anti-cancer drug within 14 days before registration, nor received other study drug (molecular targeting drug, immune therapy) within 21 days before registration
  • Not received operation under general anesthesia within 28 days before registration
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  • Not received radiation therapy (including gamma knife, cyber knife) within 14 days before registration
  • Left ventricular ejection fraction >= 50% by echocardiography or MUGA (multigated acquisition scan) within 28 days before registration
  • Having all laboratory tests performed within 14 days before registration and the values are within the following range. Patients should not receive administration of G-CSF and/or blood transfusion within 14 days before the blood collection (1) Absolute neutrophil count >= 1.500/mm3 (2) Platelet count >= 10.0 X 10(4))/mm3 (3) Hemoglobin >= 8.0 g/dL (4) Total bilirubin <= 1.5 g/dL (5) Aspartate aminotransferase (AST) <= 100 U/L (6) Alanine aminotransferase (ALT) <= 100 U/L (7) Serum creatinine <= 1.5 mg/dL
  • Patients who are able to swallow orally administered medication.
  • Consent to at least 30 days of contraception and limited egg donation (including egg retrieval for future egg transfer) after last administration of study drug for child-bearing status women. Consent to 90 days of contraception and limited sperm donation after last administration of study drug for men.
  • Written informed consent (When registering patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian.)
  • Cohort A
  • Histopathologically diagnosed as low-grade glioma, based on WHO classification of 2007, 2016 and 2021. The grade is WHO grade 1 or 2.
  • Age at the time of registration is 12 years or older (When registering a patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian), and patients who are 12-17 years old have to be 40 kg or over in body weight. There is no limitation in body weight for patients who are 18 years or older.
  • Lansky Performance Status (LPS) >= 70 for patients 12-15 years old Karnofsky Performance Status (KPS) >= 70 for patients 16 years or older
  • Having measurable disease within 28 days before registration
  • Patients suffice the following. (1) Having adequate initial treatment depending on the primary central nervous tumor including surgery if recommended treatment is available. (2) Neurologically stable.
  • Multiple lesion or dissemination is not detected with MRI at the registration.
  • 18) Not increased steroid for low-grade glioma within 14 days before registration and the dosage of steroid in equivalent to 50 mg prednisolone or less.
  • Cohort B 19) Histopathologically diagnosed as pancreatic cancer (histologically not specified).
  • 20) Having progression after at least one regimen of chemotherapy excluding adjuvant therapy.
  • 21) Age at the time of registration is 18 years or older. 22) Performance Status (ECOG) is 0 or 1 23) Having measurable disease within 28 days before registration detected by enhanced CT (Head, chest, abdominal, pelvic: under 5 mm in slice)

Who cannot join

  • Active double primary cancer (but not [1]-[3]): [1] completely resected following cancers: basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, [2] gastrointestinal cancer curatively resected with ESD or EMR, and [3] other cancers with no recurrence for more than 5 years.
  • Patients with symptomatic congestive heart failure of NYHA class II-IV or arrythmia (over grade 2) occurring in less than 6 months before registration.
  • Patients with myocardial infarction or unstable angina occurring in less than 6 months before registration.
  • Patients with corrected QT interval (QTcF) > 480 ms in ECG performed within 14 days before enrollment.
  • Patients with infections requiring systemic treatment.
  • Patients with uncontrolled hypertension (systolic blood pressure: over 150 mmHg or diastolic blood pressure: over 100 mmHg).
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  • Patients with history or findings of retinal vein occlusion (RVO) or having RVO risk factor (unstable glaucoma, ocular hypertension, hyperviscosity syndrome, hypercoagulability syndrome, etc.)
  • Patients with history or complication of retinal degenerative disease other than RVO (central serous chorioretinopathy, retinal detachment, age-related macular degeneration, etc.)
  • Patients with uncontrolled diabetes mellitis.
  • Patients with venous thrombus (transient ischemic attack, stroke, massive deep vein thrombosis, pulmonary embolism, etc.) occurring in less than 3 months
  • Patients who have neuromuscular disease with CK elevation (inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, etc.).
  • Prior treatment with MEK inhibitors.
  • Previous severe hypersensitive reaction to ingredient including binimetinib.
  • Patients who are positive for either HIV antibody, HBs antigen, or HCV-RNA.
  • Negative for HBs antigen, positive for HBs antibody or HBc antibody, and positive for HBV-DNA assay. (If it is less than or equal to the detection sensitivity, patients are not excluded)
  • Patients with concomitant diseases that affect gastrointestinal function.
  • Women who are pregnant, breastfeeding and need to continue breastfeeding in the future, and women who may be pregnant.
  • Patients with psychiatric diseases or psychological symptoms interfering with participation in the trial.
  • Patients who are deemed inappropriate for participation in the trial by the principal investigator or sub-investigator.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chigusa Morizane, M.D., Ph.D. contact

0335422511

ncch2101_office@ml.res.ncc.go.jp

Tomoyuki Satake, M.D., Ph.D. contact

ncch2101_office@ml.res.ncc.go.jp

6 sites in 1 country

Japan6 sites, 6 recruiting

  • National Cancer Center Japan

    Chuo-ku, Tokyo, 104-0045

    Chigusa Morizane, M.D., Ph.D.

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Kenji Tsuchihashi, M.D., Ph.D.

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Tomoyuki Satake, M.D.

    Recruiting

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

    Masafumi Kanai, M.D., Ph.D.

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Ichiro Kinoshita, M.D., Ph.D.

    Recruiting

  • Tohoku university Hospital

    Sendai, Miyagi, 980-8574

    Keigo Komine, M.D., Ph.D.

    Recruiting

Other trials in Japan

About this study

Official title: Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusion/rearrangement.

Read the detailed description

This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial. Eligible patients are with recurrent low-grade glioma (grade 1 and grade 2 tumors according to WHO classification) or advanced or recurrent pancreatic cancer harboring BRAF fusion/rearrangement. Patients receive binimetinib 45mg administered orally, twice daily.

Analyses will be performed on each of the two cohorts:

Cohort A: low-grade glioma Cohort B: pancreatic cancer

Being tested
Binimetinib 15 MG
Keywords
BRAF fusion, BRAF rearrangement, Binimetinib
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Binimetinib 15 MGDrug

    Binimetinib 45mg is orally administered twice daily.

Study groups in NCT06159478
Study groupRoleWhat they receive
BinimetinibExperimentalNot described
Receives: Drug: Binimetinib 15 MG

What is being measured

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

  1. Overall response rate (centrally assessed)

    Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be confirmed by independent blinded central review assessment.

    Measured: Baseline up to 4 years

Secondary outcomes (8)

  1. Overall response rate (investigator assessed by RECIST)

    Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be performed by investigator assessment.

    Measured: Baseline up to 4 years

  2. Overall response rate (investigator assessed by RANO)

    Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment.

    Measured: Baseline up to 4 years

  3. Overall response rate including minor response(investigator assessed by RANO)

    Overall response rate (ORR) defined as the combined incidence of complete response (CR) PR and SD, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment.

    Measured: Baseline up to 4 years

  4. Progression-free survival

    Progression-free survival (PFS) defined as the time from the date of enrollment to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first within cohort A FAS and cohort B FAS.

    Measured: Baseline up to 4 years

  5. Overall survival

    Overall survival (OS) defined as the time from date of enrollment to date of death due to any cause within cohort A FAS and cohort B FAS.

    Measured: Baseline up to 4 years

  6. Disease control rate

    Disease control rate (DCR) defined as the percentage of patients with a confirmed complete response (CR), partial response (PR) or stable disease (SD) as the best overall according to RECIST version 1.1 within cohort A FAS and cohort B FAS.

    Measured: Baseline up to 4 years

  7. Duration of response

    Duration of Response (DOR) defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first within cohort A FAS and cohort B FAS.

    Measured: Baseline up to 4 years

  8. Adverse event rate

    Defined as the percentage of patients who experienced each adverse event. The severity of AEs were evaluated by the investigator according to Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0-JCOG) within cohort A FAS and cohort B FAS.

    Measured: Baseline up to 4 years

Timeline

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

  1. First posted6 Dec 2023
  2. Study start29 Mar 2023
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06159478
Sponsor's protocol ID
NCCH2101/MK011
Acronym
Perfume
Status last verified
Dec 2023
First submitted
28 Nov 2023
Last updated
13 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Binimetinib 15 MG in people with Low-grade Glioma and Pancreatic Cancer, run by National Cancer Center, Japan at 6 sites in Japan.

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 23 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Chigusa Morizane, M.D., Ph.D. (0335422511, ncch2101_office@ml.res.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (centrally assessed) (time frame: Baseline up to 4 years). 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 NCT06159478.

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 13 Dec 2023.

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