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Actuate 1801: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic 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
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- •- 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.
- •- Is aged >= 18 years
- •- Part 1&2: Has pathologically confirmed advanced or metastatic malignancy
- •characterized by one or more of the following:
- •a. Patient is intolerant of existing therapy(ies) known to provide clinical
- •benefit for their condition
- •b. Malignancy is refractory to existing therapy(ies) known to potentially
- •provide clinical benefit
- •c. Malignancy has relapsed after standard therapy
- •d. Malignancy for which there is no standard therapy that improves survival by
- •at least 3 months
- •- Part 3: Has pathologically confirmed advanced, recurrent, or metastatic
- •pancreatic cancer AND is previously untreated with systemic agents in the
- •advanced/metastatic setting.
- •- Has laboratory function within specified parameters (may be repeated):
- •a. Adequate bone marrow function: absolute neutrophil count (ANC) >= 500/mL;
- •hemoglobin >= 8.5 g/dL, platelets >= 50,000/mL (75,000/mL in Part 3)
- •b. Adequate liver function: transaminases (aspartate aminotransferase/ alanine
- •aminotransferase, AST/ALT) and alkaline phosphatase <= 3 (<= 10 X the upper limit
- •of normal (ULN) in the setting of liver metastasis or infiltration with
- •malignant cells) x ULN; bilirubin <= 1.5 x ULN
- •c. Adequate renal function: creatinine clearance >= 30 mL/min (Cockcroft and
- •Gault), except for carboplatin/pemetrexed arm, which should be >= 45 mL/min
- •d. Serum amylase and lipase <= 1.5 x ULN
- •- Has adequate performance status (PS): Eastern Co-operative Oncology Group
- •(ECOG) PS 0-3
- •- Has received the final dose of any of the following treatments/ procedures
- •with the specified minimum intervals before first dose of study drug (unless in
- •the opinion of the investigator and the study medical coordinator the
- •treatments/ procedures will not compromise patient safety or interfere with
- •study conduct:
- •Chemotherapy, immunotherapy, or systemic radiation therapy - 14 days, or >= 5
- •half-lives (whichever is shorter) - Part 1&2
- •Focal radiation therapy - 7 days
- •Systemic and topical corticosteroids - 7 days - Part 1&2
- •Surgery with general anesthesia - 7 days
- •Surgery with local anesthesia - 3 days
- •- May continue endocrine therapies (e.g. for breast or prostate cancer) and/or
- •anti-human epidermal growth factor (Her2) therapies while on this study - Part
- •- 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 - Part 3
- •- May have received neoadjuvant chemotherapy with FOLFIRINOX if given at least
- •6 months before study enrollment - Part 3
- •- May have received prior cytotoxic doses of systemic chemotherapy in the
- •adjuvant setting if given at least 6 months before study enrollment - Part 3
- •- 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
- 另有 3 项未显示
排除标准
- •- Is pregnant or lactating
- •- Is known to be hypersensitive to any of the components of 9-ING-41 or to the
- •excipients used in its formulation
- •- Has endocrine or acinar pancreatic carcinoma - Part 3
- •- Has not recovered from clinically significant toxicities as a result of
- •prior anticancer therapy, except alopecia and infertility. Recovery is defined
- •as <= Grade 1 severity per Common Terminology Criteria for Adverse Events
- •(CTCAE) Version 4.03 (v 4.03)
- •- 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 9-ING-41, or cardiac
- •arrhythmia requiring medical treatment detected at screening
- •- Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41
- •or has electrocardiogram (ECG) abnormalities that are deemed medically relevant
- •by the investigator or study medical coordinator
- •- 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
- •- 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 surgerymay 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
- •consideredmajor)
- •- Has any medical and/or social condition which, in the opinion of the
- •investigator or study medical coordinator would preclude study participation
- •- 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
- •- Has a current active malignancy other than the target cancer
- •- Is considered to be a member of a vulnerable population (for example,
研究者
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