NL-OMON48925已完成不适用
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies - A Safety and Tolerability Study for patients with Advanced Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
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. Male or female subjects, age 18 years or older.
- •2. Presence of measurable disease that has been confirmed by histology or
- •cytology. Myelofibrosis subjects must have palpable spleen of * 5 cm below the
- •left subcostal margin on physical examination at the screening visit.
- •3. The following malignancy types will be included in each of the treatment
- •* Part 1 (Dose Escalation)
- •Treatment Group A: AML or myelodysplastic syndrome (MDS)
- •Treatment Group B: SCLC (other solid tumors, eg, endocrine tumors, are allowed
- •with medical monitor approval)
- •* Part 2 (Dose Expansion)
- •Treatment Group A1: Relapsed/refractory AML or MDS
- •Treatment Group A2: MF (PMF, PPV-MF, and PET-MF)
- •Treatment Group B1: SCLC
- •Treatment Group B2: Ewing's sarcoma and poorly differentiated neuroendocrine
- •* Parts 3 and 4 (Combination Dose Escalation/Expansion)
- •Treatment Group C/C1: Relapsed/refractory AML
- •Treatment Group D/D1: Newly diagnosed, treatment-naive AML, or MDS who are
- •unfit to tolerate standard intensive chemotherapy at study entry and who are
- •eligible to receive azacitidine as first-line therapy for the disease under
- •Treatment Group E/E1: SCLC previously progressed on platinum-based treatment
- •4. Subjects must meet specific disease and treatment criteria as follows:
- •* TG A/A1/A2, TG B/B1/B2, C/C1, and TG E/E1: The subject must not be a
- •candidate for potentially curative therapy or standard-of-care approved therapy.
- •* TG A2: The subjects must have confirmed diagnosis of PMF, PPV-MF, or PET-MF
- •according to revised WHO 2016 criteria.
- •* TG D/D1: Subjects with newly diagnosed, treatment-naive AML who are unfit to
- •tolerate standard intensive chemotherapy at study entry based on at least 1 of
- •the following criteria:
- •* Age * 75 years old
- •* History of congestive heart failure (CHF) or documented ejection fraction
- •(EF) * 50%
- •* Pulmonary disease with diffusing capacity of the lungs for carbon monoxide*
- •65% or FEVI * 65%, or dyspnea at rest or requiring oxygen
- •* Any other comorbidity that the physician judges to be incompatible with
- •intensive chemotherapy
- •Subjects with newly diagnosed, treatment-naïve, IPSS-R intermediate or higher
- •risk disease MDS who have at least 5% bone marrow blasts, who are unfit to
- •tolerate standard intensive chemotherapy at study entry and who are eligible to
- •receive azacitidine as first-line therapy for the disease under study.
- •The following treatments for prior lower risk MDS are acceptable:
- •Revlimid®, low-dose cytarabine, and growth factors.
- •* TG E/E1: The subjects in TG E must have previously received platinum-based
- •therapy, but additional lines of therapies are allowed. The subjects in TG E1
- •must not have received more than 1 previous line of therapy for locally
- •advanced or metastatic SCLC. The previous line of therapy must be a
- •platinum-based therapy, and the subjects must have
- •progressed on or after this treatment.
- •5. Willingness to undergo a pretreatment bone marrow biopsy or aspirate
- •(AML/MDS/MF) during screening (may be waived with medical monitor approval).
- •For subjects with solid malignancies, must have baseline archival tumor
- 另有 3 项未显示
排除标准
- •1. Receipt of anticancer medications, anticancer therapies, or investigational
- •drugs within the following interval before the first administration of study
- •drug (requirement may be waived with medical monitor approval):
- •a. < 5 half-lives or 14 days, whichever is longer, for any investigational agent
- •b. < 5 half-lives for all other anticancer medications
- •c. < 6 weeks for mitomycin-C or nitrosoureas
- •2. Any unresolved toxicity * Grade 2 from previous anticancer therapy except
- •for stable chronic toxicities (* Grade 2) not expected to resolve.
- •3. All treatment groups: prior receipt of an LSD1 inhibitor therapy. Parts 3
- •and 4 TG E/E1: prior receipt of anti*programmed cell death-1, anti*programmed
- •death ligand 1, or anti*PD-L2 antibody.
- •4. Any of the following laboratory results at screening without transfusions
- •and hematopoietic growth factor support in solid tumors (no lower limits in AML
- •and MDS, or in MF with medical monitor approval):
- •Absolute neutrophil count (× 109/L): < 1.5
- •Hemoglobin (g/dL): < 9.0
- •Platelet count (× 109/L): < 100
- •5. Laboratory and medical history parameters outside Protocol-defined range
- •unless associated with primary malignancy or metastatic disease
- •and with medical monitor approval:
- •a. Total bilirubin > 1.5 × institutional upper limit of normal (ULN) if no
- •liver metastases or > 3 × ULN in the presence of liver metastases or presence
- •of documented Gilbert syndrome (unconjugated hyperbilirubinemia).
- •b. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ×
- •institutional ULN.
- •c. Creatinine clearance < 60 mL/min based on the institutional formula., Please
- •refers to study protocol for further exclusion criteria
研究者
相似试验
进行中（未招募）
1 期
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced MalignanciesEUCTR2017-001710-28-BEIncyte Corporation215
进行中（未招募）
1 期
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced MalignanciesPotential subjects include those with advanced or metastatic malignancies who are ineligible for all therapeutic options that are standard of care or known to confer clinical benefit, or who refuse these treatments.MedDRA version: 20.0 Level: LLT Classification code 10048683 Term: Advanced cancer System Organ Class: 100000004864EUCTR2017-001710-28-NLIncyte Corporation215
进行中（未招募）
1 期
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced MalignanciesEUCTR2017-002641-29-FRIncyte Corporation420
招募中
1 期
Study of DSP-5336 in Patients with Adult Acute Leukemia.JPRN-jRCT2031210594Tada Tomohiro100
招募中
1 期
A study to investigate the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.EUCTR2020-004104-34-ITSYNDAX PHARMACEUTICALS, INC.333