ACTRN12616000228482已完成1 期
A phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed advanced or metastatic solid tumor, including glioblastoma, with no standard treatment options.
- •2. Patients with recurrent glioblastoma who satisfy all of the following may be enrolled:
- •- Progressive tumor despite prior treatment with radiation therapy and temozolomide.
- •- Measurable disease by Response Assessment in Neuro-Oncology (RANO) criteria using gadolinium-enhanced MRI scanning.
- •- Either on no glucocorticoids or on a stable dose for 7 days prior to the first dose of study therapy.
- •- No evidence of intracranial hemorrhage (except for stable grade 1 hemorrhage), not receiving therapeutic anticoagulation or anti-platelet therapy, and have a normal INR and APTT.
- •- No prior treatment with bevacizumab or other antiangiogenic drugs.
- •- No radiation in the past 3 months.
- •3. Male or female and at least 18 years of age.
- •4. Adequate organ function (ANC more or equal to 1.5 x 10 to the power of 9 /L, platelets more or equal to 75 x 10 to the power of 9 /L, Hb more or equal to 10 g/dl; total bilirubin less or equal to 1.5 times the institutional upper limit of normal (ULN); ALT and AST less or equal to 2.5 times ULN (less or equal to 5.0 times ULN if liver metastasis); plasma creatinine less or equal to 1.5 times ULN;QTc less than 450 ms (male), less than 470 ms (female).
- •5. A life expectancy of at least 12 weeks.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- •7. Female subjects are eligible if they are of:
- •a) Non-childbearing potential, defined as
- •- Previous hysterectomy or bilateral oophorectomy.
- •- Previous bilateral tubal ligation.
- •- Post-menopausal (total cessation of menses for at least 1 year).
- •b) Childbearing potential with a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 28 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:
- •- Vasectomized partner who is sterile prior to the female patient’s enrolment and is her sole sexual partner.
- •- An intrauterine device with a documented failure rate of less than 1% per year.
- •- Double barrier contraception defined as condom with a female diaphragm.
- •8. Male patients, if sexually active, must agree to use a highly-effective method of contraception (< 1% failure rate per year) with their female partners.
- •9. Provided written informed consent prior to enrollment.
排除标准
- •1. The subject has uncontrolled infection.
- •2. The subject has serious diseases such as unstable angina pectoris, myocardial infarction in the past 6 months, heart failure (New York Heart Association class more than II) or stroke within 6 months prior to the enrollment.
- •3. A gastrointestinal absorption disorder that would limit the bioavailability of an oral medication or cannot take oral drugs.
- •4. Uncontrolled brain metastases or spinal cord compression. Patients who were treated with surgical resection or radiation therapy completing at least 4 weeks earlier are eligible if they are neurologically stable, not taking glucocorticoids and have a follow-up MRI scan performed within the previous 4 weeks showing no tumor progression.
- •5. Pre-existing allergy to ACT001 or related compounds.
- •6. Treatment with other cancer therapies such as chemotherapy, biological or targeted therapy, immunotherapy or radiation therapy either currently or within 4 weeks of ACT001 dosing (6 weeks for BCNU, CCNU or mitomycin-C). An exception is focal radiation for symptomatic bone metastases, which must not be within 2 weeks of ACT001 dosing.
- •7. Unresolved toxicity from prior anti-tumour therapy, defined as toxicities (excluding alopecia) that have not resolved to less than grade 2 as scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Exceptions may be allowed for stable toxicities after discussion with the investigator and sponsor.
- •8. Major surgery within 30 days of commencing first study therapy.
- •9. Pregnant or breast-feeding females.
- •10. A history of infection with HIV or hepatitis B or C viruses
- •11. The subject has participated in other drug clinical trials less than 4 weeks prior to obtaining the informed consent.
- •12. The subject is, in the opinion of the investigator, unsuitable for any reason.
研究者
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