Relative bioavailability and comparative pharmacokinetics (blood levels of the drug) of 13-CRA oral liquid and capsule formulations: a randomised, open label, multi-dose, cross-over clinical trial in children requiring treatment cycles of 13-CRA.
- Conditions
- euroblastomaMedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10029212 Term: Nervous system neoplasms malignant NEC System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: HLGT Classification code 10029211 Term: Nervous system neoplasms malignant and unspecified NEC System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-005104-25-GB
- Lead Sponsor
- ova BioPharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
To be eligible for inclusion into this trial the patients must fulfil all of the following criteria:
1.Male or female aged from 0 years to < 21 years of age.
2.Patient with high risk neuroblastoma, or unresectable, unfavourable histology intermediate risk neuroblastoma the latter age = 18 months at diagnosis
3.Patient who is scheduled to receive at least two treatment cycles of 13-CRA.
4.Patient who cannot swallow 13-CRA capsules (i.e. requires extraction of 13-CRA from the capsules).
5.Negative pregnancy test for females of child-bearing potential before initiation of treatment, and sexually active patients and partners agreeing to undertake adequate contraceptive measures (see section 4.5).
6.Provision of a single or double lumen central venous catheter for sampling (i.e. already in place).
7.Parent(s)/legal guardian able and willing to provide written informed consent for the patient to take part in the trial.
8.Where applicable, the patient should assent to undergo blood sampling for pharmacokinetic purposes and to allow physiological measurements to be made.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
To be eligible for inclusion in this trial the patients must not meet any of the following criteria:
1.Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the trial.
2.Diagnosis of high-risk neuroblastoma (HRNBL) which is currently being treated on the SIOPEN HRNBL trial (children who have exited this trial will be eligible).
3.Known allergy to 13-CRA or any of the excipients.
4.Inadequate contraception measures in females of childbearing age.
5.Receiving concomitant treatment with tetracyclines.
CRITERIA PRIOR TO STARTING EACH CYCLE OF 13-CRA
1.Total bilirubin = 1.5 x normal, and (SGPT) ALT = 5 x normal. Veno-occlusive disease if present, should be stable or improving.
2.Skin toxicity no greater than CTCAE Grade 1(10)
3.Serum triglycerides <5.65mmol/L.
4.No haematuria and / or proteinuria on urinalysis.
5.Serum calcium = 2.9mmol/L.
6.Serum creatinine based on age / gender as follows:
AgeMaximum Serum Creatinine µmol/L
MaleFemale
1 month to < 6 months3535
6 months to < 1 year4444
1 to < 2 years 5353
2 to < 6 years 7070
6 to < 10 years 8888
10 to < 13 years 106106
13 to < 16 years 132124
= 16 years 150124
7.Patients with a seizure disorder must be well controlled and taking anticonvulsants. CNS toxicity < grade 2 (CTCAE).
WITHDRAWAL CRITERIA
1.Positive pregnancy test - pregnancy testing will be undertaken before treatment commences and routinely before each course of treatment in females of child-bearing potential. If a patient is found to be pregnant during the trial, the next course of treatment will not be given until the pregnancy has been discussed with the treating clinician, and the patient will be withdrawn from the trial whether or not treatment is continued.
2.Request of the patient, for any reason.
3.Discretion of the investigator.
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