A phase 1/2 study in which, CTX-SPL9111, the trial medication will be administered to evaluate the safety, tolerability, pharmacokinetics (distribution of CTX-SPL9111 in the body) and efficacy in patients with advanced solid tumours
- Conditions
- Patients with advanced solid tumoursMedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003424-76-GB
- Lead Sponsor
- Starpharma Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 33
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
taxanes.
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:
- oral
- intravaginal
- transdermal
? progestogen-only hormonal contraception associated with inhibition
of ovulation:
- oral
- 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
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,
itraconazo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method