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临床试验/EUCTR2017-003424-76-GB
EUCTR2017-003424-76-GB进行中（未招募）1 期

A phase 1/2 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CTX-SPL9111 (a cabazitaxel (CTX)-dendrimer conjugate) in patients with advanced solid tumours

Starpharma Pty Ltd0 个研究点目标入组 33 人开始时间: 2017年10月25日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
33
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • •1. Signed informed consent form.
  • •2. At least 18 years old.
  • •3. Patients with histologically or cytologically confirmed advanced or
  • •metastatic cancer for which no curative therapy exists and who, in the
  • •opinion of the investigator, could potentially benefit from treatment with
  • •4. Measurable or evaluable disease per RECIST version 1.1., Prostate Cancer
  • •Working Group 3 (PCWG3) consensus guidelines (i.e. prostate cancer
  • •patients with bone-only lesions) or Response Assessment in Neuro-
  • •Oncology working group consensus guidelines (RANO; patients with
  • •primary central nervous system malignancy).
  • •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • •6. Life expectancy of greater than 12 weeks.
  • •7. Reproductive inclusion criteria:
  • •a. If of childbearing potential, willing to use an effective form of
  • •contraception (see below) during chemotherapy treatment and for at
  • •least six months thereafter.
  • •Such methods include (if using hormonal contraception this method
  • •must be supplemented with a barrier method, preferably male condom):
  • •? combined (estrogen and progestogen containing) hormonal
  • •contraception associated with inhibition of ovulation:
  • •- intravaginal
  • •- transdermal
  • •? progestogen-only hormonal contraception associated with inhibition
  • •of ovulation:
  • •- implantable
  • •? intrauterine device (IUD)
  • •? intrauterine hormone-releasing system (IUS)
  • •? bilateral tubal occlusion
  • •? vasectomised partner
  • •? true sexual abstinence when this is in line with the preferred and
  • •usual lifestyle of the subject. Periodic abstinence (e.g., calendar,
  • •ovulation, symptothermal, post-ovulation methods), declaration of
  • •abstinence for the duration of a trial, and withdrawal are not
  • •acceptable methods of contraception.
  • •b. Women must have a negative pregnancy test at study entry.
  • •c. Men who are truly sexually abstinent when this is in line with the
  • •preferred and usual lifestyle of the subject or vasectomized or willing to
  • •ensure that their female sexual partners use a highly-effective means of
  • •contraception (i.e. as outlined in Inclusion criterion 7.a.) for the duration
  • •of study therapy and 6 months afterwards. In addition, men must be
  • •willing to use a condom during sexual intercourse from the first dose of
  • •CTX-SPL9111 until 6 months after their final dose, so as to protect their
  • •partner from exposure to study drug.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 11
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 22

排除标准

  • •1. 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 and have a follow-up MRI scan performed within the previous 4 weeks showing no
  • •tumour progression.
  • •2. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil
  • •count (ANC) < 1.5 × 109/L or platelet count < 100 × 109/L (cannot be post-
  • •transfusion) or haemoglobin < 10 g/dL (can be post-transfusion).
  • •3. Serum bilirubin > upper limit of normal (ULN).
  • •4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
  • •level > 1.5 × ULN.
  • •5. Serum creatinine > 1.5 × ULN; however, an exception can be made if the
  • •calculated (by the Cockcroft-Gault formula) or measured creatinine
  • •clearance is > 50 mL/min.
  • •6. History of a bleeding diathesis.
  • •7. Allergy to cabazitaxel, other components of study therapy or compounds of
  • •similar chemical composition.
  • •8. Congenital long-QT syndrome.
  • •9. Myocardial infarction within 6 months of enrolment, congestive heart failure
  • •of New York Heart Association class > II, unstable angina or unstable
  • •cardiac arrhythmias.
  • •10. Other uncontrolled intercurrent illness, including active infection.
  • •11. A history of infection with HIV or hepatitis B or C viruses.
  • •12. Participation in a study of an investigational agent within 30 days prior to
  • •first study therapy.
  • •13. Anti-tumour therapy (including chemotherapy, radiation therapy, targeted
  • •therapeutics or hormonal therapy) within the 30 days prior to first study
  • •therapy. Permitted exceptions are concurrent use of GnRH
  • •agonists/antagonists for prostate cancer and radiation to bone metastases
  • •completed > 14 days prior to first study therapy.
  • •14. Cumulative dose of corticosteroid = 150 mg prednisone (or equivalent doses
  • •of corticosteroids) within two weeks before the first IMP administration.
  • •15. Unresolved toxicity from prior anti-tumour therapy, defined as toxicities
  • •(excluding alopecia) that have not resolved to < grade 2 as scored using the
  • •Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
  • •Exceptions may be allowed for stable toxicities after discussion with the
  • •investigator and sponsor.
  • •16. Symptomatic grade 1 peripheral neuropathy.
  • •17. Peripheral neuropathy of grade 2 or higher due to any cause.
  • •18. Patients with diabetes with signs or symptoms of peripheral neuropathy or
  • •other end organ damage or those at a higher risk of peripheral neuropathy
  • •(eg: history of poor diabetes control or non-compliance with anti-diabetic medication).
  • •19. Major surgery within 30 days of commencing first study therapy.
  • •20. Pregnant or breast-feeding females.
  • •21. Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole,

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