NL-OMON53961招募中不适用
A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib (AMG 510) in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) - 20190135 - CodeBreaK 101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 3
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
- •For the full list of inclusion criteria please refer to section 5.1 of the
- •subprotocols.
- •All subprotocols:
- •Pathologically documented, metastatic colorectal cancer / metastatic
- •pancreatic cancer with KRAS p.G12C mutation identified through molecular
- •testing. KRAS p.G12C mutation must be identified by an approved diagnostic
- •device for detection of KRAS p.G12C in NSCLC or be performed in a Clinical
- •Laboratory Improvement Amendments (CLIA)-certified laboratory.
- •Measurable disease per RECIST 1.1 criteria (Section 11.8)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2
- •Life expectancy of > 3 months, in the opinion of the investigator
- •Ability to take oral medications and willing to record daily adherence to
- •investigational product
- •Corrected QT interval (QTc) <= 470 msec for women and <= 450 msec for men
- •(based on average of screening triplicates
- •Adequate hematological laboratory assessments, as follows:
- •- Absolute neutrophil count (ANC) >= 1.5 x 109/L
- •- Platelet count >= 100 x 109/L
- •- Hemoglobin >= 9 g/dL
- •Adequate renal laboratory assessments, as follows:
- •- Estimated glomerular filtration rate based on Modification of Diet in Renal
- •Disease (MDRD) calculation >= 60 ml/min/1.73 m2
排除标准
- •For the full list of exclusion criteria please refer to section 5.2 of the
- •subprotocols.
- •All sub protocols
- •History or presence of hematological malignancies unless curatively treated
- •with no evidence of disease >= 2 years
- •History of other malignancy within the past 2 years, with the following
- •exceptions:
- •- Malignancy treated with curative intent and with no known active disease
- •present for >2 years before enrollment and felt to be at low risk for
- •recurrence by the treating physician.
- •- Adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of disease.
- •- Adequately treated cervical carcinoma in situ without evidence of disease.
- •- Adequately treated breast ductal carcinoma in situ without evidence of
- •- Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- •- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma
- •Myocardial infarction within 6 months of study day 1, symptomatic congestive
- •heart failure (New York Heart Association > class II), unstable angina, or
- •cardiac arrythmia requiring medication
- •GI tract disease causing the inability to take oral medication, malabsorption
- •syndrome, requirement for IV alimentation, uncontrolled inflammatory GI disease
- •(eg, Crohn's disease, ulcerative colitis)
- •Exclusion of hepatitis infection based on the following results and/or
- •- Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic
- •Hepatitis B or recent acute hepatitis B)
- •- Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B
- •core antibody testing is not required for screening, however if this is done
- •and is positive, then hepatitis B surface antibody [antiHBs] testing is
- •necessary. Undetectable anti-HBs in this setting would suggest unclear and
- •possible infection and needs exclusion).
- •- Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase
- •chain reaction (PCR) is necessary. Detectable Hepatitis C virus RNA suggests
- •chronic hepatitis C
- •Known positive test for HIV
- •Has an active infection requiring systemic therapy
- •Received radiation therapy to the lung that is > 30 Gy within 6 months of the
- •first dose of trial treatment
研究者
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