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Trial Title:
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
NCT ID:
NCT06553365
Condition:
Nerve Sheath Tumor
Conditions: Official terms:
Nerve Sheath Neoplasms
Conditions: Keywords:
MEK
NF2
nerve sheath tumor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FCN-159
Description:
FCN-159 8mg qd po
Arm group label:
FCN-159
Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in
patients with specific NF2-associated nerve sheath tumors.
Detailed description:
1. A phase 2 single arm single center study, total 30 patients will be enrolled;
2. To evaluate the safety and efficacy of FCN-159, a Mek inhibitor, to treat NF2;
associated nerve sheath tumors, age≥16, including benign and malignant tumors;
3. Primary endpoint: Objective response rate (ORR)；Secondary Outcome Measures： Clinical
benefit rate (CBR)；24w WRS, OS et al..
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥16 years of age, regardless of gender.
2. meet the revised 2022 diagnostic criteria for NF2-associated nerve sheath tumors or
pathologically confirmed NF2-associated nerve sheath tumors.
3. should meet one of the following criteria: 1) Incomplete surgical resection, or
postoperative recurrence. 2) Systemic therapy is required as determined by the
Investigator.
4. the presence of a measurable lesion, as defined by REiNS or RECIST V1.1 criteria.
5. Karnofsky physical status score of ≥70.
6. the patient has adequate organ and bone marrow function.
7. International Normalized Ratio (INR) and activated partial thromboplastin time
(APTT) ≤ 1.5 x ULN.
8. For patients of childbearing potential: During treatment and for at least 90 days
after the last dose, patients should agree to use a highly effective method of
contraception.
9. avoid excessive sun exposure and be willing to use an adequate amount of sunscreen
in anticipation of sun exposure.
10. be able to understand and voluntarily sign a written informed consent form.
Exclusion Criteria:
- Previously received one of the following treatments:
1. Pharmaceutical or biological therapy within 3 weeks or 5 half-lives prior to
enrollment, whichever is longer.
2. Use of growth factors that promote platelet, red blood cell, or white blood
cell count or function within 7 days prior to enrollment.
3. Patients who have received major surgery or anti-tumor immunotherapy within 4
weeks prior to enrollment.
4. Radiation therapy for nerve sheath tumors within 4 weeks prior to enrollment.
5. Dose adjustment for patients treated with dexamethasone or other
corticosteroids within 1 week prior to enrollment.
6. Patients who have participated in another interventional clinical trial within
4 weeks prior to enrollment.
7. Prior treatment with Selumetinib or any other MEK 1/2 inhibitor. 2. history of
or concurrent with other malignancies. 3. inability to undergo MRI and/or
contraindications to MRI. 4. uncontrolled hypertension. 5. the presence of
dysphagia, active gastrointestinal disease, malabsorption syndrome, or other
condition that interferes with the absorption of the study medication.
6. previous or current retinal vascular disease. 7. interstitial pneumonitis
8. cardiac function or co-morbidities 9. Immediate family history of
sudden cardiac death before age 50. 10.History of any acute neurological
condition 11. with active bacterial, fungal or viral infections 12. known
hypersensitivity to the study drug, other MEK1/2 inhibitors, or their
excipients.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 15, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06553365
