NCT01695590Unknown1 期
Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Prolexys Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012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
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
详细描述
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
- To establish the dose of PRLX 93936 recommended for future studies.
- To characterize potential toxicities of PRLX 93936.
- To assess the pharmacokinetic profile of PRLX 93936.
- To evaluate response to treatment, time to response (TTR) and duration of response.
- To evaluate time to progression (TTP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient must have a diagnosis of multiple myeloma and have relapsed or relapsed/refractory disease.
- •Patient must have received ≥ 2 prior anti-myeloma regimens including a proteasome inhibitor and/or immunomodulatory agent.
- •Patient currently requires systemic therapy.
- •Patient has measurable disease.
- •Age ≥ 18 years
- •Karnofsky performance status ≥ 60%
- •ECOG performance 0, 1 or 2
- •Life expectancy of at least three months
- •Able to take acetaminophen
- •Not pregnant
- •Patient must have recovered from toxicities incurred as a result of any previous anti-myeloma therapy or recovered to baseline.
- •Patients who received an autologous stem cell transplant must be ≥ 3 months post-transplant and all associated toxicities must have resolved to ≤ CTCAE Grade
- •QT intervals of QTc ≤ 500 msec
排除标准
- •POEMS syndrome
- •Plasma cell leukemia
- •Primary amyloidosis
- •Patient has smoldering multiple myeloma or monoclonal gammopathy of unknown significance (MGUS).
- •Evidence of spinal cord compression or CNS complication unless controlled by appropriate therapy.
- •Patient received chemotherapy or other anti-cancer therapy that may be active against multiple myeloma within 3 weeks prior to the first dose of PRLX
- •Patient received nitrosureas within 6 weeks prior to the first dose.
- •Patient received corticosteroids within 2 weeks prior to the first dose.
- •Patient received plasmapheresis within 4 weeks prior to the first dose.
- •Patient had major surgery within 4 weeks prior to the first dose.
- •Patient had an allogeneic stem cell transplant within 6 months before first dose of PRLX 93936 or has evidence of graft versus host disease.
- •Patient is taking any therapy concomitantly that may be active against multiple myeloma.
- •Patient is currently receiving medication(s) that are principally metabolized via the cytochrome P450 3A4 enzyme pathway.
- •Use of any investigational agents within 28 days or 5 half-lives (whichever is shorter) of study treatment.
- •Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC.
- •Patient had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •Abnormal LVEF (< LLN for the institution for a patient of that age) on echocardiogram
- •Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to protocol.
- •Patient had a malignancy other than multiple myeloma within 3 years before enrollment, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer.
- •Patient's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1:
- •Bilirubin > 1.5 times ULN
- •AST (SGOT), ALT (SGPT) and Alkaline phosphatase > 2.5 times ULN
- •Uncontrolled hypercalcemia (defined as serum calcium > 14 mg/dL)
- •Serum creatinine > 2.0 mg/dL or creatinine clearance of < 30 mL/min
- •ANC < 1000 cells/mm3 or < 750 cells/mm3 due to >50% marrow involvement
- •Platelet count < 50,000 cells/mm3
- •Hemoglobin < 8.0 g/dL
- •Patient is known to be human immunodeficiency virus (HIV)-positive.
- •Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
- •Patient has an active systemic infection requiring treatment or within 14 days before first dose of PRLX
- •Pregnant or nursing women
研究组 & 干预措施
PRLX 93936
Experimental
PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle
干预措施: PRLX 93936 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Cycle 1 (28 days from first dose)
次要结局
- Response to treatment(Each cycle (assessed every 28 days starting from first dose, for up to 8 months))
- Time to response(From date of first dose to date of response, assessed up to 8 months)
- Duration of response(From date of response to first documented progression or death, or date last known progression-free and alive at study discontinuation, assessed up to 8 months)
- Time to progression(From date of first dose to first documented progression, assessed up to 8 months)
研究者
研究点 (6)
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