EUCTR2019-001848-21-ES进行中（未招募）1 期
A Phase 1b/2 Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Topotecan-induced Myelosuppression During Treatment for Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
- •1. Males and females age 18 years or older.
- •2. Ability to understand the requirements of this clinical trial and willingness to provide written informed consent
- •3. Histopathological confirmation of ED SCLC that has recurred or been refractory to one line of treatment with standard platinum-based chemotherapy or immuno-chemotherapy. Patients who received immunotherapy after platinum-based chemotherapy remain eligible.
- •4. Mutated TP53: no wild type (WT) TP 53 gene copies within the tumor (i.e., biallelic mutation, biallelic deletion, or mutation/deletion), as assessed by next generation sequencing (NGS)
- •5. Measurable disease using RECIST 1.1
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •7. Adequate hematological status:
- •a. absolute neutrophil count (ANC) =1500/?L
- •b. platelet count =100,000/?L
- •c. hemoglobin =9.0 g/dL
- •8. Adequate hepatic and renal function:
- •a. total bilirubin =1.5 X upper limit of normal (ULN) or = 3 X ULN in the presence of Gilbert syndrome or liver metastases
- •b. alkaline phosphatase (ALP), aspartate aminotransferase (AST [SGOT]), and alanine aminotransferase (ALT [SGPT]) = 2.5 X ULN in
- •the absence of liver metastases
- •c. ALP, AST (SGOT), and ALT (SGPT) =5 X ULN in the presence of liver metastases
- •d. serum creatinine <1.5 X ULN or calculated creatinine clearance = 40 mL/min (C&G or EDTA)
- •9. Recovery from the acute toxic effects of all prior therapies to Grade =1
- •10. The shorter of 5 half-lives or 4 weeks must have elapsed since any prior systemic therapy, unless no drug-drug interactions with study treatment would be anticipated and the patient had unequivocal radiologic disease
- •progression during the prior line of therapy.
- •11. Males and female patients of child-bearing potential must agree to use an acceptable method of birth control for the duration of study treatment and for 3 months (male patients with female partner of child-bearing potential) or 6 months (female patients of child-bearing potential) following the last dose of study treatment.
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1. Known hypersensitivity to any component of study treatment including mannitol, which is an excipient in topotecan.
- •2. More than one line of prior chemotherapy for ED SCLC (prior immunotherapy is permitted, concurrent with or subsequent to firstline chemotherapy). Previous treatment with platinum-based chemotherapy concomitant with radiotherapy for limited disease is allowed if completed at least one year prior to enrollment into the current trial.
- •3. Presence of active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable, with no evidence of radiographic or neurologic progression during the screening period and no requirement for steroids for at least 15 days before enrollment.
- •4. Uncontrolled intercurrent illness including but not limited to:
- •a. Clinically significant, active, uncontrolled infection including human immunodeficiency virus (HIV), or hepatitis B or C
- •i. Patients with HIV must be on effective antiretroviral therapy for = 4 weeks prior to enrollment and have HIV viral load < 400 copies/µL, have had no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the past 12 months, and have CD4+ count = 350 cells/µL.
- •ii. Patients with chronic hepatitis B virus (HBV) must be on antiviral therapy and have HBV viral load below the limits of detection.
- •iii. Patients with hepatitis C virus (HCV) must be on or have completed antiviral therapy and have an HCV viral load below the limits of detection.
- •b. Uncontrolled hypertension
- •c. Uncontrolled diabetes mellitus
- •5. Clinically significant electrolyte abnormalities
- •6. Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
- •7. History of prior malignancy; patients with a known malignancy that does not affect overall well-being and ability to participate in the study can be considered in consultation with the Medical Monitor.
- •8. Pregnant or lactating women
- •9. Hereditary angioedema of any severity or severe or life-threatening angioedema due to any cause.
- •10. Major surgery within 28 days of enrollment.
- •11. Significant weight loss (=15% body weight) within the 4 weeks prior to enrollment.
- •12. Treatment with an investigational agent for any indication within the shorter of 14 days or 5 half-lives, if the half-life is known
- •13. The required use of any concomitant medications that are predominantly cleared by hepatobiliary transporters, organic anion transporter polypeptide [OATP] members OATP1B1 and OATP1B3 on the day of the first ALRN-6924 infusion to within 48 hours after the last ALRN-6924 infusion in a treatment cycle
- •14. Other medications, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
研究者
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