NCT00531271终止1 期
A Phase I/II Trial of ABI-008 (Nab-docetaxel) in Patients With Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every three weeks.
研究概览
简要总结
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every 3 weeks; to characterize the toxicities of ABI-008; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule to patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase I Study
- •Each subject must meet the following criteria to be enrolled in this study.
- •Pathologically confirmed adenocarcinoma of the breast with metastasis.
- •No more than 2 prior chemotherapy regimen for metastatic breast cancer. Patient should have received anthracycline and may have received a taxane but not within 6 months for registration on the study.
- •Patient may have measurable or evaluable disease.
- •Patient may have non-measurable bone only disease.
- •At least 4 weeks since prior cytotoxic chemotherapy. Patients should have recovered from all acute effects of such therapy.
- •At least 4 weeks since radiotherapy, with full recovery.
- •At least 4 weeks since recovery from major surgery, with full recovery.
- •ECOG performance status 0-
- •Age ≥18 years.
- •Patient must have the following blood counts at Baseline:
- •WBC > 3.0 x 109 cells/L;
- •ANC ≥ 1.5 x 109 cells/L;
- •Platelets ≥ 100 x 109 cells/L;
- •Hgb ≥ 9 grams/dL.
- •Patient has the following blood chemistry levels at Baseline:
- •AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
- •Total Bilirubin < ULN;
- •Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
- •Creatinine ≤ 1.5 mg/dL.
- •Peripheral neuropathy Grade 0 or stable Grade 1, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.
- •If female of childbearing potential, serum pregnancy test is negative (within 72 hours of the first dose of study drug).
- •If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
- •Life expectancy should be ≥ 3 months.
- •Informed consent document has been obtained stating that the patient understands the investigational nature of the proposed treatment.
- •If obese, a patient must be treated with doses calculated using his/her actual body surface area (BSA) (the physician must be comfortable treating at the full BSA dose regardless of BSA).
- •Phase II Study
- •Pathologically confirmed adenocarcinoma of the breast with metastasis.
- •Patients should have not received prior chemotherapy for their metastatic disease. If a taxane is used as adjuvant or neoadjuvant therapy, at least 12 months should have elapsed from the date of the last dose.
- •Patient must have at least one measurable metastatic lesion.
- •At least 4 weeks since prior cytotoxic chemotherapy. Patients should have recovered from all acute effects of such therapy.
- •At least 4 weeks since radiotherapy, with full recovery.
- •At least 4 weeks since major surgery, with full recovery.
- •ECOG performance status 0-
- •Age ≥18 years.
- •Patient must have the following blood counts at Baseline:
- •WBC > 3.0 x 109 cells/L;
- •ANC ≥ 1.5 x 109 cells/L;
- •Platelets ≥ 100 x 109 cells/L;
- •Hgb ≥ 9 grams/dL.
- •Patient has the following blood chemistry levels at Baseline:
- •AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
- •Total Bilirubin < ULN;
- •Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
- •Creatinine ≤ 1.5 mg/dL.
- •Peripheral neuropathy Grade 0 or stable Grade 1, by NCI CTCAE v3.
- •If female of childbearing potential, serum pregnancy test is negative (within 72 hours of the first dose of study drug).
- •If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
- •Life expectancy should be ≥ 3 months.
- 另有 1 项未显示
排除标准
- •Phase I Study
- •Subjects who meet any of the following criteria will be excluded from the study.
- •Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for breast cancer. Bisphosphonates are allowed.
- •Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months).
- •History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer excluding non-melanomatous skin cancer and cervical carcinoma in situ.
- •Patients who have received an investigational drug within the previous 4 weeks.
- •Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered. A patient may not enroll in such clinical trials while participating in this study.
- •Pregnant or nursing women.
- •Patients with history of allergic reactions attributed to solvent-based docetaxel(Taxotere).
- •ECOG performance status 3-
- •Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- •Phase II Study
- •Subjects who meet any of the following criteria will be excluded from the study.
- •Prior neo-adjuvant or adjuvant chemotherapy is allowed. If a taxane was part of the adjuvant regimen, at least 12 months should have transpired since completion of taxane regimen.
- •Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for breast cancer.
- •Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months).
- •History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer excluding non-melanomatous skin cancer and cervical carcinoma in situ.
- •Patients who have received an investigational drug within the previous 4weeks.
- •Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered.
- •Pregnant or nursing women.
- •Patients with history of allergic reactions attributed to solvent-based docetaxel(Taxotere).
- •ECOG performance status 3-
- •Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel.
- •Patients with tumor overexpression of HER2/neu.
结局指标
主要结局
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every three weeks.
时间窗: End of Study (EOS) and Follow Up
次要结局
- To evaluate the safety and tolerability of ABI-008 in the metastatic breast cancer patient population; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule.(End of Study (EOS) and Follow Up)
研究者
研究点 (2)
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