CTRI/2009/091/000771Other2 期
Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of P276-00 in Patients With Relapsed and/or Refractory Mantle Cell Lymphoma
Piramal Life Sciences Limited0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 25
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
入选标准
- •1. Age >/=18 years
- •2. Histological diagnosis of MCL and presence of either nuclear Cyclin D1 positivity by immunohistochemistry or t(11;14) by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), or conventional karyotyping
- •3. Documented progression or relapse after at least 1 line of prior chemotherapy
- •4. Presence of measurable disease
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •6. Life expectancy of at least 3 months
- •7. Ability to understand and the willingness to sign a written informed consent document (ICD)
- •8. Full recovery from all prior treatment toxicities to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1
排除标准
- •1. Prior radiation therapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
- •2. Prior treatment with monoclonal antibodies or any radio- or toxin-immunoconjugates within 3 months of study drug administration; however, a patient who has had rituximab treatment within 3 months and has had PD after such treatment is allowed in the study.
- •3. Prior allogeneic stem cell transplantation within 1 year of study drug administration
- •4. Current or prior CNS lymphoma
- •5. QTc 450 msec
- •6. Unstable angina, myocardial infarction, CHF or stroke within previous 6 months of study drug administration
- •7. Presence of active and serious comorbidity and uncontrolled illness other than MCL
- •8. History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer
- •9. Hemoglobin 8.0 gm/dL
- •10. Absolute neutrophil count 1000/mm3
- •11. Platelet count 50,000/mm3
- •12. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 Ã? institutional upper limit of normal (ULN) ( 5 Ã? institutional ULN if liver is involved with lymphoma or if patient has Gilberts Disease)
- •13. Total bilirubin, 1.5 Ã? institutional ULN ( 3 Ã? institutional ULN if liver is involved with lymphoma or if patient has Gilberts Disease)
- •14. Serum creatinine 1.5 Ã? institutional ULN
- •15. Patients known to be suffering from infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B
- •16. Pregnant or lactating women
- •17. Women of childbearing potential or men not willing to use at least 2 approved methods of contraception (1 of which being a barrier method) after signing the ICD, during the entire study and for at least 4 weeks following withdrawal from the study
研究者
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