EUCTR2013-001249-15-GB进行中（未招募）1 期
A Two-Part Phase 1/2a, Open-Label, Dose-Escalation Study to Evaluate the Tolerability and Preliminary Antitumour Activity of OPB-111001 in Patients with Advanced Cancers that are Poorly Responsive to Standard Anticancer Treatment - Study Evaluating Tolerability and Anti-tumour activity of OPB 111001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •The patient should meet the following inclusion criteria to be considered for enrollment into the study
- •1. Patients =18 years of age at Screening
- •2. Patients with prostate cancer that is recurrent or did not respond to previous
- •hormone therapy and/or who have exhausted standard treatment options.
- •For the dose escalation parts only: Patients with any of the following diseases
- •who have exhausted standard treatment options:
- •a.recurrent or refractory ovarian cancer
- •b.recurrent or refractory cervical squamous cell carcinoma
- •c.recurrent or refractory breast cancer
- •d.recurrent or refractory salivary gland cancer
- •e.recurrent or refractory endometrial cancer
- •3. Histologically or cytologically documented diagnosis of cancer
- •4. Measurable disease according to Response Evaluation Criteria in Solid Tumours
- •(RECIST), Version 1.1 or
- •a.for prostate cancer also evaluable disease (nonmeasurable) defined as
- •prostate-specific antigen progression according to Prostate Cancer Working
- •Group 2 eligibility criteria
- •b.for ovarian cancer also evaluable disease (nonmeasurable) according to the
- •Gynaecologic Cancer Intergroup
- •5. Absolute neutrophil count =1.5 (1500/mm3) and platelets =100 × 10E9/L (without
- •platelet transfusion within the last 4 weeks before first study drug
- •administration), and haemoglobin =9 g/dL at Screening
- •6. Alanine aminotransferase and aspartate aminotransferase =2.5 × the upper limit
- •of normal (ULN), Total bilirubin =1.5 × ULN (exception: patients with liver
- •metastasis are allowed to have aspartate aminotransferase =5 × ULN and alanine
- •aminotransferase =5 × ULN) at screening
- •7. Albumin =26 g/L at Screening
- •8. Estimated life expectancy >3 months (as judged by investigator)
- •9. Eastern Cooperative Oncology Group performance status =1
- •10. In prostate cancer patients: ongoing therapy with luteinizing hormone
- •releasing hormone analogue or orchiectomy
- •11. Agreement of female patients of childbearing potential and male patients who
- •have partners capable of reproduction to use an effective double-barrier
- •contraceptive method during the course of the study and for 3 months following
- •the completion of their last treatment. Females of childbearing potential must
- •have a negative beta-human chorionic gonadotropin pregnancy test result within
- •3 days of the first study drug administration. Female patients who are
- •surgically sterilized or who are >45 years old and have not experienced menses
- •for >2 years may have the beta-human chorionic gonadotropin pregnancy test
- •12. Ability to understand and give written informed consent and to comply with the
- •protocol (i.e., with all study-related procedures, medication use, and
- •evaluations)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Concurrent prior treatment-related toxicity of Grade 2 or higher.
- •Exception: any toxicity that is in the view of the investigator not a clinically
- •significant safety risk for IMP administration.
- •2. Previous treatment with cytotoxic chemotherapy or other anticancer therapy
- •within 4 weeks before the first dosing with study drug (at least 6 weeks for
- •mitoxantrone, nitrosurea, and bicalutamide).
- •3. Treatment with systemic glucocorticosteroids of more than a 2 mg dexamethasone
- •equivalent (e.g., 13 mg prednisolone) per day or in cases of treatment with =2
- •mg dexamethasone equivalent per day:
- •a.Dosing was changed within 6 weeks before Screening
- •b.The patient’s cancer is responding to glucocorticosteroid intake(as by
- •investigator judgment)
- •4. Radiation therapy within 4 weeks prior to the first dosing with IMP.
- •5. Treatment with a systemic IMP in a clinical trial within 28 days before the
- •Screening visit.
- •6. Use of prohibited medications within 21 days of the first dose of IMP.
- •7. Current or past history of clinically significant gastrointestinal disease or
- •major gastrointestinal surgery, malabsorption syndrome, or other conditions that
- •could interfere with enteral absorption.
- •8. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New
- •York Heart Association classes III to IV) or a history of ventricular arrhythmia
- •requiring medication.
- •9. Patients with symptomatic central nervous system metastasis.
- •10. History of positive human immunodeficiency virus test result (enzyme-linked
- •immunosorbent assay or Western blot)
- •11. Clinical or laboratory evidence of active or chronic hepatitis B or hepatitis C
- •12. Major surgery =4 weeks before the first study drug administration or ongoing
- •side effects of previous major surgery.
- •13. Concurrent clinically significant unrelated systemic illness (e.g., serious
- •infection) or significant pulmonary, hepatic, or other organ dysfunction that
- •would compromise the patient’s ability to tolerate study treatment or would
- •likely interfere with study procedures or results.
- •14. Active treatment/chemotherapy for another primary malignancy within the past 3
- •years (except for nonmelanoma skin cancer and cervical carcinoma in situ).
- •15. Women who are pregnant or breastfeeding.
- •16. Known or suspected hypersensitivity to the excipients (ingredients) in the
- •study drug formulation.
研究者
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