EUCTR2006-002830-38-DE进行中（未招募）不适用
A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination with Pemetrexed Versus Pemetrexed Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer
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
- 180
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. Age = 18 years old.
- •2. The subject has histologically-documented NSCLC.
- •3. The subject has locally advanced (Stage III) or metastatic (Stage IV) NSCLC not
- •amenable to curative surgery or radiotherapy.
- •4. The subject has received at least 1 prior treatment regimen for NSCLC in the
- •neo-adjuvant, adjuvant or metastatic setting.
- •5. The subject has received no more than 2 prior treatment regimens for NSCLC
- •(i.e., study participation must be second-line therapy in the metastatic setting).
- •6. The subject has received no more than 1 chemotherapy treatment regimen in the
- •metastatic setting.
- •7. The subject has experienced progressive disease either during or following the
- •previous chemotherapy regimen.
- •8. The subject exhibits the presence of measurable disease by RECIST criteria.
- •9. Subjects with brain metastases must have had clinically controlled neurologic
- •symptoms, defined as surgical excision and/or radiation therapy followed by
- •30 days of stable neurologic function and no evidence of CNS disease progression.
- •(Subjects with symptoms of CNS metastasis at Screening must have computed
- •tomography [CT] or magnetic resonance imaging [MRI] scans of the brain prior to
- •study entry that demonstrate no evidence of disease.)
- •10. The subject has an Eastern Cooperative Oncology Group (ECOG) performance
- •score of 0-2.
- •11. All anti-tumor therapy has been discontinued at least 3 weeks prior to study start
- •administration.
- •12. All adverse events from prior anti-tumor treatment are resolved or stable.
- •13. Adequate hematologic, renal and hepatic function: no NYHA Class 3-4 heart failure
- •14. Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a serum pregnancy test.
- •15. All female subjects not surgically sterile or postmenopausal (for at least 1 year)
- •and non-vasectomized male subjects must practice at least one of the following
- •methods of birth control:
- •? Total abstinence from sexual intercourse during the study (minimum one complete menstrual cycle prior to study start);
- •? Vasectomized partner;
- •? Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to and during study drug administration;
- •Double-barrier method (condoms, contraceptive sponge, diaphragm, or
- •vaginal ring with spermicidal jellies or creams).
- •16. The subject's life expectancy is = 3 months.
- •17. The subject is amenable to completing the Quality of Life (QoL) questionnaire.
- •18. Subject has voluntarily signed and dated an informed consent form, approved by
- •an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to
- •any 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
- •1. The subject has greater than Grade 1 NCI CTCAE (Version 3.0) neurology
- •category findings (e.g., paresthesia, deep tendon reflexes, or weakness that is
- •subjective and/or does not interfere with function).
- •2. The subject has a documented allergy to sulfa medications.
- •3. The subject has previously received ABT-751 or pemetrexed.
- •4. The subject has received more than one investigational agent for NSCLC
- •as a single agent or part of a previous regimen. (An investigational agent is any
- •drug not currently approved for use in humans. Please contact the Abbott medical
- •monitor with questions regarding investigational agents.)
- •5. The subject exhibits significant weight loss (= 10%) during the 6 weeks before
- •study entry.
- •6. The subject has glucose-6-phosphate dehydrogenase deficiency and/or porphyria.
- •7. The subject has a significant history of cardiac, renal, neurologic, psychiatric,
- •endocrinologic, metabolic, or hepatic disease that would adversely affect his/her
- •participating in this study. Questions regarding inclusion of individual subjects
- •should be directed to the Abbott medical monitor.
- •8. The subject has a current history of a Class 3-4 cardiovascular disability status in
- •accordance with the New York Heart Association Functional Classification.
- •? Class 3 is defined as marked limitation of physical activity, comfortable at
- •rest, but less than ordinary activity causes fatigue or dyspnea.
- •? Class 4 is defined as being unable to carry on any physical activity without
- •symptoms and symptoms are present even at rest. Also, if any physical
- •activity is undertaken, symptoms are increased.
- •9. A female subject is pregnant or breastfeeding.
- •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 of
- •initiation of study
- •? previous nonpulmonary malignancy, which has been treated with surgery,
- •chemotherapy, or radiation therapy and is considered cured by the
- •investigator, may be approved by the Abbott Medical Monitor.
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