EUCTR2007-002143-25-DE进行中（未招募）不适用
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •Phase 1 Inclusion Criteria
- •A subject will be eligible for study participation if he/she meets the following criteria:
- •1. The subject must be = 18 years of age.
- •2. The subject must have alemtuzumab-refractory CLL or relapsed or refractory CLL
- •with contraindications against the use of alemtuzumab and require treatment in the
- •opinion of the investigator.
- •3. The subject has an Eastern Cooperative Oncology Group performance score
- •4. Subjects receiving Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants
- •(e.g., Prozac) must be receiving a stable dose for at least 21 days prior to the first
- •dose of study drug.
- •5. The subject must have adequate bone marrow, renal and hepatic function. Please see protocol for more information.
- •6. Female subjects must be surgically sterile, postmenopausal (for at least one year),
- •or have negative results for a pregnancy test. Please see protocol for more information.
- •7. All female subjects not surgically sterile or postmenopausal (for at least one year)
- •and non-vasectomized male subjects must practice at least one of the methods of birth control described in the protocol.
- •8. The subject must voluntarily sign and date an informed consent, approved by an
- •Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to
- •the initiation of any screening or study-specific procedures.
- •Phase 2a Inclusion Criteria
- •A subject will be eligible for study participation if he/she meets the following criteria:
- •1. The subject must be = 18 years of age.
- •2. The subject must have CLL and require treatment in the opinion of the
- •investigator.
- •3. The subject has alemtuzumab-refractory disease or the subject has relapsed disease with contraindications against the use of alemtuzumab and has received no more than 5 prior myelosuppressive/chemotherapy regimens (see Section 5.1).
- •4. Subject has an Eastern Cooperative Oncology Group performance score of = 1.
- •5. Subjects receiving Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants
- •(e.g., Prozac) must be receiving a stable dose for at least 21 days prior to the first
- •dose of study drug.
- •6. The subject must have adequate bone marrow independent of growth factor support (with the exception of subjects with ANC < 1000/µL and bone marrow heavily infiltrated with underlying disease [80% or more]), renal and hepatic function, per local laboratory reference range at Screening as follows:
- •7. Female subjects must be surgically sterile, postmenopausal (for at least one year),
- •or have negative results for a pregnancy test. Please see protocol for more information.
- •8. All female subjects not surgically sterile or postmenopausal (for at least one year)
- •and non-vasectomized male subjects must practice at least one of the methods of birth control described in the protocol.
- •9. The subject must voluntarily sign and date an informed consent, approved by an
- •Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •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
- •Phase 1 and Phase 2a Exclusion Criteria
- •A subject will not be eligible for study participation if he/she meets any of the following criteria:
- •1. The subject has a history or is clinically suspicious for cancer-related Central
- •Nervous System (CNS) disease.
- •2. The subject has a recent history (within 1 year prior to first dose of study drug) of
- •an underlying, predisposing condition of bleeding or currently exhibits signs of
- •3. The subject has undergone an allogeneic or autologous stem cell transplant.
- •4. The subject has active peptic ulcer disease or other potentially hemorrhagic
- •esophagitis/gastritis.
- •5. The subject has active immune thrombocytopenic purpura or a history of being
- •refractory to platelet transfusions (within 1 year prior to the first dose of study
- •6. The subject is currently receiving or requires anticoagulation therapy or any drugs
- •or herbal supplements that affect platelet function, with the exception of low-dose
- •anticoagulation medications that are used to maintain the patency of a central
- •intravenous catheter.
- •7. Subject has received steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug with the exception of inhaled steroids for asthma, topical steroids or replacement/stress corticosteroids.
- •8. The subject has received aspirin within seven days prior to the first dose of study
- •9. The subject has received any anti-cancer therapy including chemotherapy,
- •immunotherapy, radiotherapy, hormonal (with the exception of hormones for
- •thyroid conditions or estrogen replacement therapy [ERT]), or any investigational
- •therapy within 14 days prior to the first dose of study drug, or has not recovered to
- •less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of the
- •previous therapy.
- •10. The subject has received a biologic within 30 days prior to the first dose of study
- •11. The subject has consumed grapefruit or grapefruit products within 3 days prior to
- •the first dose of study drug.
- •12. The subject has a significant history of cardiovascular disease (e.g., myocardial
- •infarction [MI] thrombotic, or thromboembolic event in the last 6 months), renal,
- •neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic
- •disease that in the opinion of the investigator would adversely affect his/her
- •participating in this study.
- •13. A female subject is pregnant or breast-feeding.
- •14. The subject has tested positive for HIV (due to potential drug-drug interactions
- •between anti-retroviral medications and ABT-263, as well as anticipated ABT-263 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections and potential drug-drug interactions with certain anti-infective agents).
- •15. The subject has a history of other active malignancies within the past 3 years prior to study entry, with the exception
- •? adequately treated in situ carcinoma of the cervix uteri;
- •? basal or squamous cell carcinoma of the skin;
- •? previous malignancy confined and surgically resected with curative intent. 16. The subject exhibits evidence of other clinically significant uncontrolled
- •condition(s) including, but not limited to:
- •? uncontrolled systemic infection (viral, bacterial, or fungal);
- •? diagnosis of fever and neutropenia within one week prior to study drug
- •administration.
- •17. The subject has received known CYP3A inhibitors (e.g., ketoconazole) within 7 days prior to first dose of study drug.
研究者
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