EUCTR2018-003739-32-PT进行中（未招募）1 期
Actuate 1801: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3ß) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematological Malignancies or Solid Tumors. - Actuate 1801: Phase 1/2 of 9-ING-41 in Refractory Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 512
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Only Part 3B criteria are listed:
- •1. Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures
- •2. Is aged = 18 years
- •3. Has pathologically or cytologically confirmed metastatic pancreatic cancer AND is previously untreated with systemic agents in the recurrence/metastatic setting AND would be a candidate to receive gemcitabine/nab-paclitaxel as a first-line treatment
- •4. Must have at least 1 measurable lesion per RECIST v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI)
- •5. Has laboratory function within specified parameters (may be repeated):
- •a.Adequate bone marrow function: absolute neutrophil count (ANC) = 1500/mL; hemoglobin = 8.5 g/dL, platelets = 100,000/mL
- •b.Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase = 5 x the upper limit of normal (ULN); bilirubin = 1.5 x ULN
- •c. Adequate renal function: serum creatinine = ULN OR creatinine clearance = 60 mL/min for patients with a serum creatinine >ULN (calculated by the Cockcroft and Gault formula)
- •6. Has Eastern Co-operative Oncology Group (ECOG) PS 0 or 1
- •7. Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug:
- •Focal radiation therapy – 7 days
- •Surgery with general anesthesia – 7 days
- •Surgery with local anesthesia – 3 days
- •8. May have received treatment with fluorouracil or gemcitabine as a radiation sensitizer in the adjuvant setting if the treatment was received at least 6 months before study enrollment
- •9. Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first study therapy. Women may be neither breastfeeding nor intending to become pregnant during study participation and must agree to use effective contraceptive methods (hormonal or barrier method of birth control, or true abstinence) for the duration of study participation and in the following 6 months after discontinuation of study treatment
- •10. Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 3 months after discontinuation of study treatment and use appropriate barrier contraception or true abstinence
- •11. Must not be receiving any other investigational medicinal product
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 341
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 171
排除标准
- •Only Part 3B criteria are listed:
- •1. Is pregnant or lactating
- •2. Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation
- •3. Has endocrine or acinar pancreatic carcinoma
- •4. Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and/or infertility. Recovery is defined as = Grade 2 severity per CTCAE, v5.0
- •5. Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of study therapy, or uncontrolled cardiac arrhythmia
- •6. Has had a myocardial infarction within 12 weeks of the first dose of study therapy or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator
- •7. Has symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Patients with stable brain metastases or leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
- •8. Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major)
- •9. Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation.
- •10. Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.
- •11. Has a current active malignancy other than pancreatic cancer
- •12. Is considered to be a member of a vulnerable population (for example, prisoners).
研究者
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不适用
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