CTRI/2023/05/052954招募中1 期
A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR107 in Patients with Relapsed Advanced Malignancies (SHAKTI-1) - SHAKTI-1
Aurigene Oncology Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1.Males and females = 18 years of age.
- •2.Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
- •3.Acceptable bone marrow and organ function at screening as described below:
- •a.ANC = 1500/µL (without WBC growth factor support).
- •b.Platelet count = 100,000/µL without transfusion support.
- •c.Hemoglobin = 9 g/dL (Transfusion is allowed to achieve this Hb).
- •d.Total Bilirubin = 1.5 x ULN; (Patients with known Gilbert’s syndrome are allowed with a Total Bilirubin = 2.5 x ULN).
- •e.AST (SGOT) = 3 x ULN (= 5 × ULN if known liver metastases).
- •f.ALT (SGPT) = 3 x ULN (= 5 × ULN if known liver metastases).
- •g.Creatinine clearance (CrCl) = 60 mL/min (either measured or estimated by the Cockcroft-Gault formula).
- •4.Ability to swallow and retain oral medications.
- •5.Histo-pathological diagnosis of a solid tumor.
- •Note: The solid tumors must be in Stage IV at screening.
- •6.Evidence of measurable disease per RECIST, v1.1 for solid tumors (Eisenhauer et al. 2009).
- •7.Standard curative measures do not exist, and patient must have exhausted all effective therapies, available locally.
- •7a. At a minimum, solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer).
- •7b. Any cancer patient with access to any effective therapy must not be enrolled.
排除标准
- •1.Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study.
- •Note: Concomitant use of low dose prednisone (up to 10 mg/day) or medroxyprogesterone is allowed.
- •Note: Patients with CRPC (castrate resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogues, and such patients are allowed.
- •2.Presence of an acute or chronic toxicity resulting from prior anti-cancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade = 1, as determined by NCI CTCAE v 5.0.
- •3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
- •Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- •4.Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1 (The list of these medications is provided in specific rows within Table 5).
- •Note: This class of drugs are also prohibited during DLT evaluation period and must be either avoided or used with caution beyond DLT evaluation period.
- •5.Known symptomatic or untreated or recently treated (= 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated ( > 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed.
- •6.Major surgery = 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
- •7.Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
- •8.Active infection requiring systemic therapy.
- •Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.
- •9.Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
- •10.Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve).
- •11.The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.
- •12.Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.
- •13.Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
- •14.QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
- •15.Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any
研究者
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