EUCTR2017-004578-33-GB进行中（未招募）1 期
A Safety Study of Oraxol (HM30181 + oral paclitaxel) in Cancer Patients - A Safety Study of Oraxol in Cancer Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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. Signed written informed consent
- •2. Males and females =18 years of age on day of consent
- •3. Cancer patients for whom treatment with IV paclitaxel at 80 mg/m2 has been recommended by their oncologist, either as monotherapy or in combination with other agents
- •4. Adequate hematologic status:
- •Absolute neutrophil count (ANC) =1.5 x 109/L
- •Platelet count =100 x 109/L
- •Hemoglobin (Hgb) =90 g/L
- •5. Adequate liver function as demonstrated by:
- •Total bilirubin of =20 µmol/L or =30 µmol/L for participants with liver metastasis
- •Alanine aminotransferase (ALT) =3 x upper limit of normal (ULN) or =5 x ULN if liver metastasis is present
- •Alkaline phosphatase (ALP) =3 x ULN or =5 x ULN if liver or bone metastasis are present
- •ALP >5 x ULN if liver or bone metastasis are present and the major fraction of ALP is from bone metastasis, at the discretion of the Investigator
- •Gamma glutamyl transferase (GGT) <10 x ULN
- •6. Adequate renal function as demonstrated by serum creatinine =177 µmol/L or creatinine clearance >50 mL/min as calculated by the Cockcroft and Gault formula
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •8. Life expectancy of at least 3 months
- •9. Willing to fast for 8 hours before and 4 hours after Oraxol administration on all treatment days (but may have water 1 hour after completion of Oraxol dosing and as needed with other prescribed medications)
- •10. During the inpatient PK sampling week(s):
- •Willing to abstain from alcohol consumption for 3 days before the first dose of Oraxol through the completion of protocol-specified PK sampling for that treatment week
- •Willing to refrain from caffeine consumption for 12 hours before the first dose of Oraxol through the completion of protocol-specified PK sampling for that treatment week
- •11. Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for the duration of their participation in the study. Women of childbearing potential must agree to use contraception for 30 days after their last dose of study drug.
- •12. Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
- •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 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Eligible participants must not have/be:
- •1. Currently taking a prohibited concomitant medication:
- •Strong inhibitors (eg, ketoconazole) or strong inducers (eg, rifampin or St. John's Wort) of cytochrome P450 (CYP) 3A4 (within 2 weeks prior to the start of dosing in the study)
- •Strong inhibitors (eg, gemfibrozil) or strong inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study)
- •Strong P-gp inhibitors (eg, verapamil) or strong inducers (eg, rifampin). Participants who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication =1 week before dosing and remain off that medication through the end of study treatment.
- •An oral medication with a narrow therapeutic index known to be a P-gp substrate (eg, digoxin, dabigatran) within 24 hours prior to start of dosing in the study
- •2. Use of warfarin. Participants receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
- •3. Unresolved toxicity from prior chemotherapy (participants must have recovered all significant toxicity to = Grade 1 CTCAE toxicity from previous anticancer treatments or previous investigational agents). This does not extend to symptoms or findings that are attributable to the underlying disease
- •4. Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer
- •5. Women of childbearing potential who are pregnant or breastfeeding
- •6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant myocardial infarction within the last 6 months, unstable angina pectoris, clinically significant cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or psychiatric illness/social situations that would limit compliance with study requirements
- •7. Major surgery to the upper GI tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption
- •8. A known history of allergy to paclitaxel. Participants whose allergy was due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.
- •9. Any other condition which the Investigator believes would make a subject’s participation in the study not acceptable
研究者
相似试验
已完成
2 期
A Safety Study of Oraxol (HM30181 + oral paclitaxel) in Cancer PatientsACTRN12615000881538Kinex Pharmaceuticals Inc44
已完成
2 期
A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer PatientsSolid TumorNCT04180384Athenex, Inc.44
尚未招募
Unknown
A phase II study of oral paclitaxel (Liporaxel) in GIST patientsNeoplasmsKCT0009438Asan Medical Center28
招募中
不适用
Clinical Efficacy and Safety Assessment of Oxaliplatin and Fluorouraciland, Leucovorin [modified FOLFOX6] in Combination with High-dose Bevacizumab as Second-line Therapy in Patients with Advanced or Recurrent Colorectal Cancer after Failure to Irinotecan. Multicenter Clinical Study.Patients with advanced or recurrent colorectal cancer after failure to Irinotecan.JPRN-UMIN000009748Third Department of Surgery,Tokyo Medical University70
招募中
1 期
Epidemiological study with Phtalox® mouthwash and the clinical relationship of individuals with a diagnosis of COVID-19Coronavirus InfectionsEpidemiologyAsymptomatic infectionsC01.925.782.600.550.200D004813C01.125RBR-6c9xnw3Empresa TRIALS Saúde Bucal