EUCTR2012-002326-75-ES进行中（未招募）不适用
A multicentre, open label, early stopping design, proof of concept study with tasquinimod in treating patients with advanced or metastatic hepatocellular, ovarian, renal cell and gastric carcinomas.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Pharma
- 入组人数
- 200
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
- •All Patients:
- •1. Able and willing to provide written informed consent and to comply with the study protocol and procedures
- •2. Age ?18 years
- •3. ECOG performance status 0 or 1
- •4. Life expectancy greater than 3 months in the Investigator?s opinion
- •5. Disease progression during or after previous cancer treatment
- •6. Measurable disease as per RECIST Criteria (v1.1)
- •7. The following time must have elapsed between previous therapy for cancer and first administration of tasquinimod:
- •- At least 2 weeks since previous systemic targeted therapy with small molecule inhibitors, which includes any tyrosine-kinase inhibitor
- •- At least 4 weeks since the last dose of systemic anti-cancer therapy other than targeted therapy,
- •- At least 1 week since prior hormonal therapy
- •- At least 3 months since prior interferon therapy
- •8. Recovery to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
- •9. At least 4 weeks since any major surgery or open biopsy and 7 days since a core biopsy before first study treatment
- •10. Adequate renal function:
- •- Creatinine ?1.5 times upper limit of normal (ULN) or calculated creatinine clearance (CrCl) ?60 mL/min or measured CrCl ?60 mL/min
- •11. Adequate hepatic function:
- •- Serum bilirubin ?1.5 mg/dL (?25 ?mol/L) for OC, RCC and GC, serum bilirubin ?3 mg/dL (?50 ?mol/L) for HCC
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?2.5 x ULN (?5 x ULN if liver lesions present)
- •12. Adequate bone marrow function:
- •- Absolute neutrophil count ?1.5 x 109/L
- •- Platelets ?50 x 109/L
- •- Haemoglobin ?90 g/L
- •13. Adequate coagulation tests: international normalised ratio (INR) ?1.5 x ULN
- •14. Able to swallow capsules
- •15. For women of childbearing potential, a negative pregnancy test must be documented prior to first administration of study treatment
- •16. For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use adequate methods of contraception during the treatment period and for at least 3 months after the last dose of study treatment
- •17. For men: agreement to use a barrier method of contraception
- •during the treatment period and for at least 3 months after the last dose of study treatment
- •H18. Histologically confirmed and documented HCC (excluding fibrolamellar carcinoma)
- •H19. BCLC stage C or B not amenable to locoregional therapy or refractory to locoregional therapy
- •H20. Liver mass measuring at least 2 cm with characteristic vascularisation seen on either triphasic CT scan or MRI with gadolinium
- •H21. At least one measurable or evaluable lesion that is viable (i.e. vascularised), and has not been previously treated with locoregional therapy. A lesion that has been previously treated will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
- •H22. Child-Pugh A Class only
- •H23. Previously treated with sorafenib. Patients may have experienced radiographically documented disease progression during sorafenib therapy or after discontinuation of sorafenib therapy
- •H24. The patient has received sorafenib as the most recent systemic
- •therapeutic intervention
- •H25. Signed additional consent for a maximum of two liver biopsies during the study
- •O18. Histologically confirmed and documented ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- •O19. Progression within 6 months of a platinum containing chemotherapy regimen
- •O20. Progression after up t
排除标准
- •All Patients:
- •1. Other primary malignancy within the past 3 years (except for
- •fully-resected non-melanoma skin cancer, localised prostate
- •cancer with normal prostate specific antigen level, or cervical
- •cancer in situ)
- •2. Known central nervous system metastasis that is symptomatic
- •and/or requires treatment
- •3. Malabsorption (other than in patients with GC and partial or
- •complete gastrectomy) or intestinal obstruction
- •4. History of pancreatitis
- •5. Essential medications that are known potent inhibitors or
- •inducers of cytochrome P450 (CYP) 3A4
- •6. Ongoing treatment with CYP1A2 (including warfarin) or
- •CYP3A4 metabolised drug substance with narrow therapeutic
- •range at the start of study. Treatment with low molecular
- •weight heparin (LMWH) is permitted
- •7. History of myocardial infarction, unstable angina, congestive
- •heart failure New York Heart Association class III/IV,
- •cerebrovascular accident, transient ischaemic attack, limb
- •claudication at rest in the previous 6 months, or ongoing
- •symptomatic dysrhythmias, or uncontrolled atrial, or
- •ventricular arrhythmias, or uncontrolled hypertension defined
- •as systolic blood pressure ?150 mmHg or diastolic blood
- •pressure ?90 mmHg
- •8. Evidence of bleeding diathesis or known coagulopathy
- •9. History of venous thromboembolic disease within 3 months
- •prior to first administration of study treatment
- •10. The patient has current, severe and uncontrolled medical
- •condition such as infection, diabetes mellitus or other
- •systemic disease
- •11. Any condition or illness that, in the opinion of the
- •Investigator or the medical monitor, would compromise
- •patient safety or interfere with the evaluation of the safety of
- •12. Has known positive serology for human immunodeficiency
- •13. Investigational drug within 28 days or within five times the
- •elimination half-life (whichever is longest) prior to first dose
- •of study treatment
- •14. Known allergy to treatment medication or its excipients.
- •Hepatocellular Carcinoma (Cohort H)
- •H15. Fibrolamellar carcinoma.
- •Ovarian Carcinoma (Cohort O)
- •O15. Non-epithelial cancer and borderline tumours (e.g., tumours
- •of low malignant potential).
- •Gastric Carcinoma (Cohort G)
- •G15. Other histologic type than adenocarcinoma.
研究者
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