NCT00723359已完成1 期
A Phase I Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), and Safety of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
This Phase I research study is to test the effects (good and bad) and best dose of BT062 in treating patients with relapsed or refractory multiple myeloma.
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
- •Diagnosis of active multiple myeloma according to the International Myeloma Working Group diagnostic criteria
- •Relapsed or relapsed/refractory multiple myeloma
- •Previous treatment with both an immunomodulator and a proteosome inhibitor therapy
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤ 2
- •Ability to understand and willingness to sign a written informed consent document
- •Ability to adhere with the study visit schedule and other protocol procedures
- •Life expectancy of ≥ 12 weeks
- •Normal organ and marrow function
排除标准
- •Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C)prior to day 1 or those who have not recovered from AEs due to agents administered more than 3 weeks earlier
- •Treatment with another investigational agent during the study or within 4 weeks before day 1
- •Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
- •Antineoplastic therapy with biological agents within 2 weeks before day 1
- •HAHAs, HACAs, or HAMAs in response to previous MAb therapy
- •Previous participation in this study
- •Malignancy within 3 years before day 1, excluding treated non-melanoma skin cancer, superficial bladder cancer and carcinoma in-situ of the cervix
- •Severe diseases of skin, colon, esophagus, or eye within 1 year before day 1, as judged by the Investigator
- •Severe infections necessitating use of antibiotics
- •Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease which,in the judgment of the investigator, would make the subject inappropriate for enrollment into this study
- •Acute or relevant abnormalities in electrocardiogram (ECG), as judged by the Investigator
- •Significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina, uncontrolled congestive heart failure, uncontrolled hypertension, (recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg), uncontrolled cardiac arrhythmias, grade 3 or greater cardiac toxicity from prior chemotherapy
- •History of clinically significant drug or alcohol abuse
- •Unwillingness or inability to adhere to the requirements of the study
- •Concomitant therapy with corticosteroids (except as indicated in low dose for other medical conditions such as inhaled steroid for asthma, or as premedication for administration of certain medications or blood products and for treatment of infusion reactions if needed)
- •Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
- •Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he or she are included in the study
- •Pregnant or breast-feeding
- •Unwillingness to use an effective contraceptive method during the study and at least 3 months after administration of study drug - unless subject is naturally infertile. (Acceptable contraceptive methods include oral or injectable contraceptives, intrauterine devices (IUD), double-barrier method, contraceptive patch, surgical sterilization, or condoms.)
- •Positive serum or urine pregnancy test
研究组 & 干预措施
BT062
Experimental
BT062 single agent dose escalation
干预措施: BT062 (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: On a weekly basis for the duration of the study
Maximum tolerated dose
时间窗: About every 2 months for the duration of the study
次要结局
- Qualitative and quantitative toxicities(On a weekly basis for the duration of the study)
- Pharmacokinetics(On a weekly basis for the duration of the study)
- Anti-tumor activity(At the beginning of each treatment cycle)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple MyelomaMultiple MyelomaNCT01001442Biotest Pharmaceuticals Corporation35
已完成
1 期
BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple MyelomaMultiple MyelomaNCT01638936Biotest Pharmaceuticals Corporation64
已完成
1 期
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid TumorsTumorsNCT00298675Sanofi59
已完成
1 期
BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal CancerOvarian NeoplasmsPeritoneal NeoplasmsNCT01314105Boehringer Ingelheim19
已完成
1 期
A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic SyndromeRelapsed Acute Myeloid Leukemia (AML)Refractory Acute Myeloid Leukemia (AML)High-risk Myelodysplastic Syndrome (MDS)NCT03787498Opna Bio LLC22