EUCTR2015-000287-34-GB进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Trial of Crenolanib in Subjects with Advanced or Metastatic Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
入选标准
- •1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
- •2. Measurable disease as per RECIST 1.1
- •- A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
- •3. Disease progression per RECIST 1.1 within 6 months (±2) of randomization
- •4. Subjects (male or female) = 18 years of age
- •5. Adequate bone marrow function, defined as:
- •- ANC of = 1000 /µL
- •- Platelet count of = 75 x 10^9/L
- •6. Adequate hepatic function, defined as:
- •- Serum total bilirubin = 1.5 x upper limit of normal (ULN)
- •- Serum aspartate aminotransferase (AST) = 2.0 x ULN
- •- Serum alanine aminotransferase (ALT) = 2.0 x ULN
- •7. Adequate renal function, defined as:
- •- Serum creatinine = 1.5 x ULN or
- •- Creatinine clearance estimate of = 50 mL/min (as calculated according to Cokcroft-Gault formula or MDRD formula for subjects > 65 years).
- •8. Female subjects with reproductive potential must have negative serum or urine pregnancy test
- •Female subjects who meet at least one of the following criteria are defined as women of non-reproductive potential:
- •- =50 years old and naturally amenorrheic for = 1 year
- •- Permanent premature ovarian failure confirmed by a gynecologist
- •- Previous bilateral salpingo-oophorectomy
- •- XY genotype, Turner’s syndrome, or uterine agenesis
- •9. Prior treatment with imatinib, sunitinib, regorafenib, dasatinib, nilotinib and/or other experimental TKIs is allowed. Recovered from prior treatment-related toxicity to Grade = 2 per CTCAE v4.03 or the subject’s baseline preceding the prior treatment.
- •10. Eastern Cooperative Oncology Group (ECOG) performance status of = 2
- •11. Adequate contraception:
- •- Female subjects with reproductive potential in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 30 days after ending treatment
- •- Male subjects in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 90 days after ending treatment
- •12. Written informed consent before any study-specific procedure is performed
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
- •2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •- Active infection with HBV is defined as:
- •o Acute hepatitis B (diagnosed < 6 months prior to randomization), or
- •o Serologic test positive for HBV surface antigen (HBsAg) positive, or
- •o Serologic test positive for immunoglobulin (IgM) to HBV core antigen (IgM anti-HBc)
- •- Active infection with HCV is defined as:
- •o Acute hepatitis C (diagnosed < 6 months prior to randomization), or
- •o Positive for HCV ribonucleic acid (RNA)
- •Subjects with history of positive anti-HCV screening test (e.g. enzyme immune-assay [EIA], chemiluminescence immunoassay [CIA], or recombinant immunoblot assay [RIA]) should be tested for HCV RNA
- •3. History of other malignancy within the past 3 years, except:
- •- Malignancy treated with curative intent and with no evidence of disease and considered to be at low risk of recurrence by the treating physician
- •- Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease
- •- Adequately treated cervical carcinoma in situ with no evidence of disease
- •- Adequately treated breast ductal carcinoma in situ with no evidence of disease
- •- Adequately treated prostatic intraepithelial neoplasia with no evidence of disease
- •- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ with no evidence of disease
- •4. Any disorder that compromises the subject’s ability to give written informed consent and/or to comply with study procedures
- •5. Any severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator, may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results
- •6. Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
- •7. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug’s halflife in subject is known) prior to randomization, whichever is shorter
- •8. Prior administration of crenolanib
研究者
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