NL-OMON53846已完成不适用
A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286 in Subjects with Metastatic Uveal Melanoma - FHD-286-C-001
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject must be >= 18 years of age.
- •2. Subject must have a diagnosis of metastatic histologically or cytologically
- •confirmed UM. If histologic or cytologic confirmation of the tumor is not
- •available, clinical confirmation of a diagnosis of metastatic UM, as per
- •standard practice for UM, by the treating investigator can be obtained, and
- •fall into any of the following categories:
- •Newly diagnosed subject who has not yet received liver-directed or systemic
- •Subject ineligible for any available therapy likely to convey clinical benefit
- •Subject who has disease progression after treatment with available therapies
- •and/or who is intolerant to those treatments.
- •Note: Inclusion criterion 15 provides timing requirements for prior therapy.
- •3. Subject must have measurable disease by RECIST v1.1, defined as at least 1
- •lesion that can be accurately measured in at least 1 dimension (longest
- •diameter to be recorded) as >= 10 mm with calipers and/or CT scan. Measurable
- •lesions cannot have undergone any local treatment (including liver-directed
- •radio- or immune- therapies) or radiation, unless there has been interim
- •progression of that lesion, nor can any local treatment or radiation involving
- •measurable lesions be anticipated.
- •Note: A malignant lymph node must be >= 15 mm on the short axis when assessed by
- •CT scan to be considered pathologically enlarged and measurable.
- •4. Subject must be able to understand and be willing to sign an informed
- •5. Subject must be willing and able to comply with scheduled study visits and
- •treatment plans.
- •6. Subject must be willing to undergo all study procedures (fresh biopsies at
- •baseline, at least 1 additional biopsy on-treatment, and 1 EOT biopsy [unless
- •contraindicated due to medical risk]; archival biopsies of sufficient sample
- •size collected within 6 months of first dose and subsequent to other prior
- •therapies will be accepted as a substitute for a fresh baseline biopsy; other
- •exceptions to this are at the discretion of the Sponsor), laboratory testing,
- •and imaging every 8 weeks for 48 weeks and 12 weeks thereafter until
- •relapse/progression, start of alternate anticancer therapy, or withdrawal from
- •the study, independent of dose delays, interruptions, or reductions.
- •7. Subject must have adequate venous access for blood collection.
- •8. Subject must have an ECOG PS of <= 2.
- •Arm 2 (Dose Expansion Phase): Subjects enrolling in Arm 2 must have an ECOG
- •PS of <= 3.
- •9. Subject must have a life expectancy of >= 3 months.
- •Arm 2 (Dose Expansion Phase): Subjects enrolling in Arm 2 must have a life
- •expectancy of >= 2 months.
- •10. Subject must have adequate hepatic function as evidenced by:
- •Serum total bilirubin <= 1.5 × upper limit of normal (ULN) (<= 3.0 × ULN for
- •subjects with Gilbert*s syndrome)
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 3.0 × ULN
- •(<= 5.0 × ULN if liver metastases are present)
- •Prothrombin time (PT) <= 1.5 × ULN or international normalized ratio (INR) <=
- •Activated partial thromboplastin time (aPTT) <= 1.5 x ULN
- •Note: Anticoagulation therapy is permitted as long as coagulation parameters
- •are within therapeutic range.
- •No known portal vein thrombosis
- •Note: Subjects with organ function outside the parameters outlined in the above
- 另有 1 项未显示
排除标准
- •1. Subject is unable to provide informed consent and/or to follow protocol
- •requirements.
- •2. Subject has thrombocytopenia (platelets < 50 × 109/L) or another major
- •bleeding disorder/diathesis.
- •Note: Subjects with platelets < 50 × 109/L may be permitted to enroll only in
- •Arm 2 of the Dose Expansion Phase at the discretion of the Investigator and the
- •3. Subject has active brain metastases and/or leptomeningeal disease. Subjects
- •with known central nervous system (CNS) metastases are only permitted under the
- •following conditions; exceptions may be made on a case-by-case basis with
- •approval of the Sponsor: Brain metastases must have been stable for
- •approximately 2 months since completion of most recent CNS-directed
- •intervention. Subject may be on corticosteroids so long as the dose is stable
- •for approximately 14 days or decreasing at the time of study entry.
- •Anti-epileptic therapy is allowed so long as medications are not otherwise
- •excluded (see exclusion criteria 13 and 14) and seizures have been controlled
- •for approximately 4 weeks since last anti-epileptic medication adjustment.
- •Dose Escalation Phase: Subjects with known CNS metastases that meet the above
- •conditions are permitted to enroll in dose escalation.
- •Arm 1 (Dose Expansion Phase): Subjects with known or suspected CNS metastases
- •are excluded from Arm 1.
- •Arm 2 (Dose Expansion Phase): Subjects with CNS metastases that meet the
- •above conditions are permitted to enroll in Arm 2.
- •4. Subject has other malignancy which may interfere with the diagnosis and/or
- •treatment of metastatic UM.
- •5. Subject has active hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •infections; subjects with a sustained viral response to HCV treatment or
- •immunity to prior HBV infection will be permitted. Subject has known positive
- •HIV antibody results or acquired immunodeficiency syndrome (AIDS)-related
- •illness; subjects with CD4+ T-cell counts >= 350 cells/µL will be permitted, as
- •will subjects who have not had an AIDS-related illness within the past 12
- •6. Subject has an active infection. Subject is permitted to enroll once any
- •required antibiotic and/or antifungal therapy has been completed and/or
- •infection is determined to be controlled.
- •7. Subject has an uncontrolled intercurrent illness.
- •8. Subject has corrected QT interval (QTc) using Fridericia*s formula (QTcF) >
- •470 msecs or other factors that increase the risk of QTc prolongation or
- •arrhythmic events (eg, heart failure, hypokalemia, family history of long QT
- •interval syndrome) including heart failure that meets New York Heart
- •Association (NYHA) class III and IV definitions (see Appendix 15.2). Subjects
- •with bundle branch block and a prolonged QTc should be reviewed by the Sponsor
- •for potential inclusion.
- •9. Subject has any other medical or psychological condition, deemed by the
- •Investigator to be likely to interfere with a subject*s ability to sign
- •informed consent, cooperate, or participate in the study.
- •10. Subject has known hypersensitivities to components of the FHD-286
- •formulation.
- •11. Subject is unable to tolerate the administration of oral medication or has
- •gastrointestinal (GI) dysfunction that would preclude adequate absorption,
- •distribution, metabolism, or excretion of study drug.
- •12. Subject is participating in any other clinical tri
研究者
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