NL-OMON40385撤回不适用
A Phase I, exploratory, intra-patient dose escalation study to investigate the preliminary safety, pharmacokinetics, and anti-tumor activity of pasireotide (SOM230) s.c. followed by pasireotide LAR in patients with metastatic melanoma or metastatic Merkel cell carcinoma - pasireotide sc. in metastatic melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- ovartis
- 入组人数
- 4
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
- •1. Adult male or female, age *18 years
- •2. Female patients of child bearing potential must have a negative pregnancy test at screening
- •3. Histologically or cytologically confirmed unresectable (stage III) and/or metastatic (stage IV) melanoma or unresectable and/or metastatic Merkel cell carcinoma
- •4. No mutation in BRAF and NRAS genes (for melanoma patients only)
- •5. Patients must have lesions that can be biopsied
- •6. Presence of measurable or non-measurable disease according to RECIST 1.0 (Appendix 14.1)
- •7. ECOG Performance Status of 0 or 1
- •8. Adequate organ function
- •* WBC * 2.5 x 109/L
- •* ANC * 1.5 x 109/L
- •* Platelets * 100 x 109/L
- •* Hemoglobin * 9 g/dL
- •* Serum creatinine * 1.5 mg/dL
- •* Serum lipase * 1.5 ULN
- •9. Life expectancy of at least 12 weeks
排除标准
- •1. Patients with unknown BRAF or NRAS mutational status (for melanoma patients only)
- •2. Primary uveal melanoma
- •3. Patients with symptomatic CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
- •4. Prior treatment with somatostatin analogue or radiolabeled somatostatin analogs
- •5. Patients for whom standard treatment is available and indicated due to rapidly progressive or aggressive disease
- •6. Patients who received more than 3 prior lines of systemic therapy for the treatment of the disease
- •7. Patients receiving any anti-neoplastic therapy within the 4 weeks prior to baseline
- •8. Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis
- •9. Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits)
- •10. Patients on continuous anticoagulation therapy.
- •11. Patients who are not biochemically euthyroid
- •12. QT-related exclusion criteria
- •* Baseline QTcF >450 ms
- •* History of syncope or family history of idiopathic sudden death
- •* Known history of prolong QT syndrome
- •* Sustained or clinically significant cardiac arrhythmias
- •13. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- •14. Pregnant or nursing (lactating) women
- •15. Women of child-bearing potential, UNLESS they are
- •* Women whose sexual orientation precludes intercourse with a male partner
- •* Women whose partners have been sterilized by vasectomy or other means
- •* Using a highly effective method of birth control
- •16. Baseline ALT or AST > 3 x ULN
- •17. Baseline total bilirubin > 1.5x ULN
- •18. Presence of Hepatitis B surface antigen (HbsAg)
- •19. Presence of Hepatitis C antibody test (anti-HCV)
- •20. History of, or current alcohol misuse/abuse within the past 12 months prior to visit 1 (baseline)
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