EUCTR2007-004097-32-ES进行中（未招募）不适用
Estudio en fase III, abierto y multicéntrico de ABI-007 frente a dacarbazina en pacientes con melanoma maligno metastásico no tratados previamente.An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients with Metastatic Malignant Melanoma.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 514
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
- •1. Histologically or cytologically confirmed malignant melanoma with evidence of metastasis (Stage IV).
- •2. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Priortreatment with kinase inhibitors or cytokines is permitted. No prior adjuvant cytotoxicchemotherapy is permitted. Prior adjuvant therapy with interferon, GM-CSF and/orvaccines is permitted.
- •3. Male or non-pregnant and non-lactating female, and ? 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (ß-hCG) within 72 hours prior to first study drug administration. If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
- •4. No other current active malignancy within the past 3 years.
- •5. Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion).
- •6. Patient has the following blood counts at Baseline:
- •- ANC ? 1.5 x 109 cells/L;
- •- platelets ? 100 x 109 cells/L;
- •- Hgb ? 9 g/dL.
- •7. Patient has the following blood chemistry levels at Baseline:
- •- AST (SGOT), ALT (SGPT) ? 2.5x upper limit of normal range (ULN); ? 5.0 xULN if hepatic metastases present;
- •- total bilirubin ? ULN;
- •- creatinine ? 1.5 mg/dL.
- •- LDH ? 2.0 x ULNa
- •8. Expected survival of > 12 weeks.
- •9. ECOG performance status 0-1.
- •10. Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of or current evidence of brain metastases, including leptomeningeal involvement.
- •2. Patient has pre-existing peripheral neuropathy of NCI CTCAE Scale of Grade ? 2.
- •3. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- •4. Patient has a clinically significant concurrent illness.
- •5. Patient is, in the investigator?s opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
- •6. Patient is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. Marker studies or studies evaluating biological correlates are permitted.
- •7. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
研究者
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