CTRI/2010/091/000200已完成1 期
A PHASE 1, OPEN LABEL, NON-RANDOMIZED, MULTI-ARM, MULTI-CENTRE, PARALLEL SEQUENCE STUDY TO DETERMINE THE MAXIMUM TOLERATED DOSE AND THE DOSE LIMITING TOXICITY OF GENOPEP 1 (ISSAR 1) IN RELAPSED SOLID TUMOUR CANCER PATIENTS
ISSAR Pharmaceuticals Pvt Ltd0 个研究点目标入组 160 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
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
- •INCLUSION CRITERIA:
- •- Patients with histologically or cytologically confirmed diagnosis of any solid tumour.
- •- Patients who have failed at least one or two lines of treatment or who have cancer that cannot be cured by any known treatment method.
- •- Patients of either sex, aged between 18 and 75 years.
- •- Performance status of 0 to 2 on the ECOG or Zubrod scale.
- •- Clinically measurable or assessable disease with either progression at least within 6 months after first line chemotherapy (resistant disease) and/or recurrence of disease within 6 months of first line chemotherapy (recurrent disease) or conditions for which there exists no standard first line chemotherapy.
- •- Estimated life expectancy of at least 12 weeks (as per the discretion of Principal Investigator).
- •- Adequate bone marrow reserve:
- •- WBC ≥4 x 109 /L
- •- Platelets ≥100 x 109 /L
- •- Haemoglobin ≥10 g/dl
- •- Adequate liver function:
- •- Bilirubin ≤ 1.5 mg/dl.
- •- ALT/AST less than 3 times the ULN and if liver metastasis, less than 5 times the ULN.
- •- Alkaline phosphatase less than 3 times the ULN and if liver metastasis, less than 5 times the ULN.
- •Renal function:
- •- Renal function: serum creatinine ≤ 1.5 mg/dl
- •- Ejection fraction ≥ 50% or the institutional normal limit
- •- If Female Patients: Child-bearing potential either terminated by surgery, radiation, or menopause, or attenuated by the use of an approved contraceptive method (Intrauterine device, birth control pills, or barrier device) during and for 3 months after trial.
- •- Negative ß-HCG/urine dip-stick test prior to the study entry, where child-bearing potential is not terminated.
- •- Patients should be able to comply with the study procedures and schedule.
- •- Patients should be able to understand study information provided and give informed consent, after being explained by the study team. He/She must be aware of the experimental nature of the study, its potential benefits, side effects, risks and discomforts.
排除标准
- •EXCLUSION CRITERIA
- •- CNS metastasis (active or inactive).
- •- Serious concomitant systemic disorders incompatible with the study (at the discretion of the Principal Investigator).
- •- Patients should not have received hormonal therapy within 1 week, or undergone major surgery within 4 weeks, or radiotherapy and/or chemotherapy within 4 weeks prior study entry (6 weeks for nitrosoureas and/or mitomycin C).
- •- Known hypersensitivity to Immunoglobins.
- •- Radiotherapy to >25 % of bone marrow.
- •- Subjects less than the age of 18 years.
- •- Pregnant or breast feeding women.
- •- Hypersensitivity and allergies to proteins/peptides
- •- Currently enrolled in any other investigational drug study.
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