NL-OMON49456撤回2 期
A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis - Array 818-201
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 10
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must meet all the following criteria to be eligible for enrollment in
- •1. Able to provide written informed consent. Adult patients under guardianship
- •may participate if permitted by local regulations with the consent of their
- •legally authorized guardian. All local regulations concerning patients under
- •guardianship must be followed.
- •2. Age * 18 years at the time of informed consent.
- •3. Histologically confirmed diagnosis of cutaneous melanoma with metastases to
- •4. Presence of BRAFV600 mutation in tumor tissue previously determined by a
- •local PCR or NGS-based assay at any time prior to Screening or by a central
- •laboratory during Screening.
- •5. Patients are required to submit archival or fresh tissue and a blood sample
- •prior to enrollment. Tissue samples will be used to determine BRAFV600-mutation
- •status by central laboratory.
- •6. Must have at least 1 parenchymal brain lesion * 0.5 cm and * 4 cm, defined
- •as an MRI contrast-enhancing lesion that may be accurately measured in at least
- •1 dimension.
- •Note: Measurable intracranial lesions that have been previously irradiated and
- •have not been shown to be progressing following irradiation should not be
- •considered as target lesions.
- •7.Patients may have received the following prior therapies:
- •a.Safety Lead-in, Phase 2 Randomized , Phase 2 Arm A Cohort 1: May have
- •received prior local therapy for brain metastases including but not restricted
- •to brain surgery, whole brain radiotherapy (WBRT), stereotactic radiotherapy or
- •stereotactic radiosurgery (e.g. gamma knife, linear-accelerated-based
- •radiosurgery, charged particles, and CyberKnife). Multiple local (brain)
- •therapies or combinations of local therapies are allowed. For patients
- •receiving local therapy to all brain lesions (including WBRT), progression of
- •pre-existing lesions based on RECIST 1.1 (> 20% increase in longest diameter on
- •baseline scan) or new measurable lesions are required. For patients receiving
- •local therapy for some but not all lesions, disease progression based on RECIST
- •1.1 is not required as long as there are remaining brain lesions that are
- •measurable and not previously treated.
- •b.Phase 2 Arm A Cohort 2: Received no prior local therapy (e.g., brain surgery,
- •craniotomy, SRS or SRT) for brain metastases.
- •c.All patients (Safety Lead-In and Phase 2): May have received prior
- •immunotherapy.
- •d.All patients (Safety Lead-In and Phase 2): If receiving concomitant
- •corticosteroids must be on a stable or decreasing dose (up to a total daily
- •dose of 4 mg of dexamethasone or equivalent) for at least 2 weeks prior to
- •first dose of study treatment.
- •8.An ECOG PS of 0 or 1 and Karnofsky score * 80
- •9. Adequate bone marrow, organ function and laboratory parameters:
- •a. ANC * 1.5 × 109/L;
- •b. Hemoglobin * 9 g/dL with or without transfusions;
- •c. Platelets * 100 × 109/L;
- •d. AST and ALT * 2.5 × ULN; in patients with liver metastases * 5 × ULN;
- •e. Total bilirubin * 1.5 × ULN; NOTE: Patients with documented Gilbert syndrome
- •or hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may
- •be enrolled following discussion and agreement with the SponsorMedical Monitor.
- •f. Serum creatinine * 1.5 × ULN; OR calculated creatinine clearance > 50 mL/min
- 另有 1 项未显示
排除标准
- •Patients meeting any of the following criteria are not eligible for enrollment
- •in the study.
- •1.Patients with symptomatic brain metastasis (e.g., have neurologic symptoms
- •related to brain metastases).
- •2.Prophylactic or preventive anti-epileptic therapy. Note: Anti-epileptic
- •therapy indicated in order to prevent neurologic symptoms caused by a
- •preexisting condition and not related to brain metastasis is allowed.
- •3.Known hypersensitivity or contraindication to any component of study
- •treatment or their excipients.
- •4. Inability to swallow and retain study treatment.
- •5. Uveal or mucosal melanoma.
- •6. History of or current leptomeningeal metastases.
- •7.Treatment with SRS or craniotomy within 14 days prior to start of study
- •treatment, or treatment with whole-brain radiation within 28 days prior to
- •study treatment. Patients who received local therapy should have complete
- •recovery with no neurological sequelae.
- •8. Either of the following:
- •a. Radiation therapy to non-brain visceral metastasis within 2 weeks prior to
- •start of study treatment;
- •b. Continuous or intermittent small-molecule therapeutics or investigational
- •agents within 5 half-lives of the agent (or within 4 weeks prior to start of
- •study treatment, when half-life is unknown).
- •9. Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 6
- •months prior to enrollment. Patients treated in the adjuvant setting with BRAF
- •or MEK inhibitors * 12 months prior to enrollment are eligible. Patients who
- •received BRAF or MEK inhibitors in the metastatic setting are excluded.
- •10. Is currently participating in a study and receiving an investigational
- •agent; has received an investigational agent or used an investigational device
- •within 14 days prior to start of study treatment.
- •11. Patients who have undergone major surgery (e.g. inpatient procedure with
- •regional or general anesthesia) * 6 weeks prior to start of study treatment.
- •For minor surgical procedures * 6 weeks prior to start of study treatment,
- •consult the Sponsor Medical Monitor.
- •12. Patient has not recovered to * Grade 1 from toxic effects of prior therapy
- •before starting study treatment. NOTE: Stable chronic conditions (* Grade 2)
- •that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior
- •therapy-related endocrinopathies) are exceptions and patients with these may
- •13. Impaired cardiovascular function or clinically significant cardiovascular
- •disease including, but not limited to, the following:
- •a. History of acute coronary syndromes (including myocardial infarction,
- •unstable angina, coronary artery bypass grafting, coronary angioplasty or
- •stenting) < 6 months prior to Screening;
- •b. Congestive heart failure requiring treatment (New York Heart Association
- •Grade * 2);
- •c. An LVEF < 50% as determined by MUGA or ECHO;
- •d. Uncontrolled hypertension defined as persistent systolic blood pressure *
- •150 mmHg or diastolic blood pressure * 100 mmHg despite current therapy;
- •e. History or presence of clinically significant cardiac arrhythmias (including
- •resting bradycardia, uncontrolled atrial fibrillation or uncontrolled
- •paroxysmal supraventricular tachycardia);
- 另有 3 项未显示
研究者
相似试验
撤回
2 期
A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT).MYELODYSPLASTIC SYNDROMES (MDS)1003522710024324NL-OMON46021Celgene Corporation40
撤回
2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac SurgeryNL-OMON55701Allergan Ltd.30
撤回
2 期
A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group, group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for the treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.NL-OMON51124Boehringer Ingelheim10
撤回
2 期
A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORSsolide tumorenabnormal cellular and tumor growth in an organSolid tumorsNL-OMON44717F. Hoffmann-La Roche Ltd.2
撤回
2 期
A Randomized, Open-Label Phase 2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma.NL-OMON55480Eli Lilly1