A Phase I Pilot Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin in Previously Untreated, Locally Advanced, or Metastatic Squamous Non-small-cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Axelar AB
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin
研究概览
简要总结
This is a open single-center, explorative, Phase I pilot dose finding study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin.
详细描述
Open single-center, explorative, Phase I pilot study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin. Patients will be treated within the study for 2 treatment cycles of 3 weeks each. Survival data will be obtained. Tumor assessment will be conducted at baseline and then at the end of the study period. Concomitant supportive therapies will be allowed.
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
- •At least 18 years of age.
- •Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic squamous non-small-cell lung cancer (stage IIIB or IV) and scheduled for treatment with cytotoxic chemotherapy (Gemcitabine HCL/Carboplatin)
- •Preserved major organ functions, i.e:
- •B-Leukocyte count ≥ 3.0 x 109/L
- •B-Neutrophil count ≥ 1.5 x 109/L
- •B-Platelet count ≥ 75 x109/L
- •B-Haemoglobin ≥ 100 g/L (transfusions are allowed)
- •P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the "normal" (i.e. reference)range
- •P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the "normal" range, ≤5 times if liver metastases have been documented
- •P-Creatinine ≤ 1.5 times upper institutional limit of the "normal" range
- •12-lead ECG with normal tracings; or clinically nonsignificant changes that did not require medical intervention
- •Signed written informed consent.
排除标准
- •The presence of any of the following criteria will exclude the patient from participating in the study:
- •Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient
- •Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization. (Patients with grade 2 constipation within the past 14 days could be re-screened if constipation decreases to ≤ grade 1 with optimal management of constipation.)
- •Known malignancy in Central Nervous System (CNS)
- •Disease and dementia and neuropathy grade more than 1
- •Other active malignancy during the previous 3 years
- •Major surgical procedure within 4 weeks
- •Prior anti-tumor therapy apart from radiation therapy
- •Women Of Child Bearing Potential (WOCBP) - For purposes of this study, WOCBP include any female who has experienced menarche and who is not postmenopausal. Post menopause is defined as: Amenorrhea ≥ 12 consecutive months without another cause
- •Pregnancy or lactation
- •Current participation in any other interventional clinical trial
- •Performance status > ECOG 2 after optimization of analgesics
- •Life expectancy less than 3 months
- •Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
- •Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
研究组 & 干预措施
AXL1717 in combination with Gemcitabine HCL and Carboplatin
AXL1717 in combination with Gemcitabine HCL and Carboplatin
干预措施: AXL1717 (Drug)
结局指标
主要结局
Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin
时间窗: End of two cycles, i.e. 6 weeks
A dose finding pilot study to evaluate safety and pharmacokinetics in combination with Gemcitabine HCL and Carboplatin during two treatment cycles, i.e. 6 weeks.
次要结局
未报告次要终点