NCT00780663已完成2 期
A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
Cylene Pharmaceuticals11 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression.
研究概览
简要总结
This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.
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
- •Histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. Patients with neuroendocrine tumors associated with MEN1 syndrome are eligible.
- •Measureable disease by RECIST
- •Unresectable or metastatic disease
- •Secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers
- •Males and females 18 years of age or older.
- •Zero to two prior cytotoxic chemotherapy regimens.
- •Patients may be receiving concomitant octreotide Sandostatin®
- •Patients must have central IV access, or agree to the insertion of a central IV line.
- •All previous cancer therapies, radiation, and surgery, must have been discontinued at least 21 days prior to the start of treatment.
- •Acceptable liver function
- •Acceptable renal function
- •Acceptable hematologic status
- •ECOG Performance Status ≤
- •Anticipated survival of at least 6 months.
- •Able to maintain a patient diary.
- •For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
- •Ability to understand the requirements of the study, provide written informed consent and agree to abide by the study restrictions and return to the clinic for required assessments.
排除标准
- •Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma.
- •Pregnant or nursing women.
- •Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
- •Seizures not controlled by anticonvulsant therapy.
- •Participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational therapy.
- •Patients with a second malignancy requiring active treatment.
- •Active symptomatic bacterial, fungal, or viral infection including active HIV or viral hepatitis.
- •Prior treatment with quarfloxin.
- •Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
- •Patients who have exhibited allergic reactions to a similar structural compound or formulation.
- •Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
研究组 & 干预措施
Quarfloxin
Experimental
Single arm study - open label.
干预措施: Quarfloxin (Drug)
结局指标
主要结局
Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression.
时间窗: monthly for clinical benefit, every two months for tumor progression
次要结局
- Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.(One year)
研究者
研究点 (11)
Loading locations...
相似试验
终止
2 期
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract CancerBiliary Tract Cancer (BTC)NCT03790111TerSera Therapeutics LLC53
撤回
2 期
Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic SyndromesMyelodysplastic SyndromesNCT01302106Fondazione Italiana Sindromi Mielodisplastiche-ETS
招募中
1 期
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid TumorsSafetyTolerabilityEfficacyNCT06639256Sichuan Huiyu Pharmaceutical Co., Ltd258
招募中
2 期
Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion MutationsNon Small Cell Lung CancerNCT06514027BeBetter Med Inc30
已完成
2 期
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseNCT03487913Palladio Biosciences31