EUCTR2006-003298-28-GB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 Small Cell Lung Cancer (SCLC) or other non-hematological malignancies.
Abbott Laboratories Limited (Queenborough, Kent, ME11 5EL, England)0 个研究点目标入组 90 人开始时间: 2006年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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. The subject must be = 18 years of age.
- •2. The subject must have histologically documented diagnosis of small cell lung
- •cancer (North America and UK) or other non-hematological malignancy (North
- •America only) measurable by CT or MRI as defined by RECIST. Target lesion(s)
- •may not have received radiation therapy.
- •3. The subject has received at least 1 prior chemotherapy treatment regimen(s) and
- •their disease is refractory or the subject has experienced progressive disease
- •following the treatment.
- •4. Subjects with brain metastases must have clinically controlled neurologic
- •symptoms, defined as surgical excision and/or radiation therapy followed by
- •21 days of stable neurologic function and no evidence of CNS disease progression
- •as determined by CT or MRI within 21 days prior to the first dose of study drug.
- •5. The subject has an Eastern Cooperative Oncology Group performance score
- •6. 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.
- •7. Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range at Screening (see protocol).
- •8. Female subjects must be surgically sterile, postmenopausal (for at least one year), or have negative results for a pregnancy test (see protocol for details of pregancy test)
- •9. All female subjects not surgically sterile or postmenopausal (for at least one year) and non-vasectomized male subjects must practice suitable method(s) of birth control (as defined in the protocol).
- •10. The subject, or legal representative, must voluntarily sign and date an informed consent, apprpved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •11. In the Investigator's opinion, the subject's life expectancy is at least 30 days.
- •Criteria 1,4,6,7,8,9, 10, 11 for phase 1, plus criteria (numbered as they appear in the protocol):
- •2. The subject must have histologically documented diagnosis of small cell lung
- •cancer (SCLC).
- •3. The subject has extensive-stage SCLC and is chemotherapy naïve (US only) or the
- •subject has experienced progressive disease following at least one chemotherapy
- •regimen or their disease is refractory.
- •5. Subjects with brain metastases must have clinically controlled neurologic
- •symptoms, defined as surgical excision and/or radiation therapy followed by
- •21 days of stable neurologic function and no evidence of CNS disease progression
- •as determined by CT or MRI within 21 days prior to the first dose of study drug.
- •12. The subject, or legal representative, 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.
- •13. In the investigator's opinion, the subject's life expectancy is at least 30 days.
- •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
- •Phases 1 & 2a
- •1. The subject has an underlying, predisposing condition of bleeding or currently
- •exhibits signs of bleeding. The subject has a recent history of non-chemotherapy
- •induced thrombocytopenia-associated bleeding within one year prior to first dose
- •of study drug.
- •2. The subject has active peptic ulcer disease or other potentially hemorrhagic
- •esophagitis/gastritis.
- •3. The subject has a history of platelet autoantibodies or autoimmune phenomena
- •including immune thrombocytopenic purpura (ITP) or autoimmune hemolytic
- •anemia (AIHA).
- •4. 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.
- •5. The subject has received any anti-cancer therapy including chemotherapy,
- •immunotherapy, radiotherapy, hormonal (with the exception of hormones for
- •hypothyroidism or estrogen replacement therapy (ERT), biologic (with the
- •exception of colony stimulating factors [G-CSF, GM-CSF] or erythropoietin), or
- •any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 clinically significant adverse
- •effect(s)/toxicity(s) of the previous therapy.
- •6. The subject has consumed grapefruit or grapefruit products within 3 days prior to
- •the first dose of study drug.
- •7. The subject has a significant history of cardiovascular disease (e.g., 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. Questions regarding inclusion of individual subjects should be directed to
- •the Abbott Medical Monitor or designee.
- •8. A female subject is pregnant or breast-feeding.
- •9. 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).
- •10. The subject has previous or current malignancies at other sites, with the exception
- •? adequately treated in situ carcinoma of the cervix uteri;
- •? basal or squamous cell carcinoma of the skin;
- •? previous nonpulmonary malignancy (e.g., localized prostate cancer) confined
- •and surgically resected with no evidence of disease within three years. 11. The subject exhibits evidence of other clinically significant uncontrolled
- •condition(s) including, but not limited to:
- •? active systemic fungal infection;
- •? diagnosis of fever and neutropenia within one week prior to study drug
- •administration.
- •12. Subject has received aspirin within seven days prior to the first dose of study drug.
- •13. The subject has received steroid therapy 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.
研究者
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