NCT01110486已完成1 期
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-348 as Monotherapy, in Combination With Carboplatin or in Combination With Docetaxel in Subjects With Advanced Solid Tumors
AbbVie (prior sponsor, Abbott)2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Study the pharmacokinetic of ABT-348
研究概览
简要总结
The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.
详细描述
The primary purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel. The secondary purpose of this study is to evaluate safety at the recommended Phase 2 dose and evaluate preliminary efficacy data regarding objective response rate time to progression, duration of overall response, and ECOG performance status of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.
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
- •Histological confirmation of locally advanced or metastatic solid tumor.
- •That is either refractory after standard of care therapy for the disease for which standard of care therapy is not reliably effective or does not exists, or
- •For which carboplatin has been determined to be an appropriate therapy, per the investigator, or
- •For which docetaxel has been determined to be an appropriate therapy, per the investigator.
- •Eastern Cooperative Oncology Group Status of 0-2
- •Serum creatinine value of ≤ 1.5 times the upper limit of normal (ULN) and either an estimated creatinine clearance value as determined by the Cockcroft-Gault formula or based on a 24 hour urine collection creatinine clearance value of ≥ 50 mL/min
- •Adequate liver function as demonstrated by serum bilirubin < 2 x ULN and AST and ALT ≤ 2.5 x ULN
- •Adequate bone marrow as demonstrated by absolute neutrophil count (ANC) ≥ 1,500/mm2 (1.5 x 109/L); Platelets ≥ 100,000/mm2 (100 x 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)
- •QTc interval < 500 msec
- •Left Ventricular Ejection Fraction > 50%
- •Women of child-bearing potential and men must agree to use adequate contraception (one of the following listed below) prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy.
- •Capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study-specific procedures.
排除标准
- •Subject has known active CNS involvement. The subject has untreated brain or meningeal metastases.
- •Subject has received anti-cancer therapy within a period of 21 days or 5 half lives (whichever is shorter) prior to Study Day 1
- •Subject has unresolved toxicities from prior anti-cancer therapy, grade 2 or higher clinically significant toxicity (excluding alopecia)
- •Subject has had major surgery within 28 days prior to Study Day 1
- •Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 90 mmHg or systolic blood pressure > 140 mmHg
- •Subject has proteinuria grade > 1
- •Subject is receiving therapeutic anticoagulation therapy. Low dose anti coagulation (e.g., low dose heparin or warfarin) for catheter prophylaxis will be permitted.
- •Clinically significant uncontrolled condition(s) 9.Psychiatric illness/social situation that would limit compliance with study requirements
- •Subject has a known infection with HIV, Hepatitis B or Hepatitis C
- •Subject with poorly controlled diabetes mellitus
- •Subject enrolled in Arm A, B, C and D is unable to swallow or absorb oral tablets normally
- •Any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
- •Female subjects who are lactating or pregnant
- •Subject enrolled in Arm E has hypersensitivity to drugs formulated with polyethoxylated castor oli (Cremophor)
研究组 & 干预措施
Monotherapy, once daily
Experimental
干预措施: ABT-348 (Drug)
Combination with carboplatin
Experimental
干预措施: ABT-348 and carboplatin (Drug)
Combination with docetaxel
Experimental
干预措施: ABT-348 and docetaxel (Drug)
Monotherapy, twice daily
Experimental
干预措施: ABT-348 (Drug)
IV Monotherapy, once daily
Experimental
干预措施: ABT-348 (Drug)
结局指标
主要结局
Study the pharmacokinetic of ABT-348
时间窗: At study visits
Determine the safety profile (Adverse events by toxicity grade and relationship to study drug, serious adverse events, adverse events leading to discontinuation and relevant clinical laboratory abnormalities) of ABT-348 as monotherapy or in combination
时间窗: At each treatment visit
Dose limiting toxicity determination
时间窗: At each treatment visit until dose-limiting toxicities observed
次要结局
- Evaluate safety at the recommended Phase 2 dose (RPTD) and schedule of ABT-348 as monotherapy, when in combination with carboplatin or in combination with docetaxel.(At RPTD treatment visit)
- Evaluate preliminary efficacy data regarding objective response rate (ORR), time to progression (TTP), duration of overall response, and ECOG performance status of ABT-348 as monotherapy, when in combination with carboplatin or docetaxel.(At each treatment visit)
研究者
研究点 (2)
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