EUCTR2016-005104-25-GB
Active, not recruiting
Phase 1
Relative bioavailability and comparative pharmacokinetics of 13-CRA oral liquid and extracted capsule formulations: a randomised, open label, multi-dose, cross-over clinical trial in patients requiring treatment cycles of 13-CRA. - My-CRA, Liquid 13 Cis Retinoic Acid
ova BioPharma Limited0 sites20 target enrollmentStarted: November 6, 2017Last updated:
ConditionseuroblastomaMedDRA 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]
DrugsRoaccutane
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ova BioPharma Limited
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
Similar Trials
Completed
Phase 1
Comparative Bioavailability of Smartech 2% Sodium Diclofenac Topical Solution and PENNSAID 2% Applied to the Knees of Healthy Male and Female SubjectsACTRN12622001391763Avance Clinical Pty Ltd32
Completed
Phase 1
Oral Liquid 13-cis-retinoic Acid (13-CRA)NeuroblastomaNCT03291080Nova Laboratories Limited20
Not yet recruiting
Phase 1
Comparative evaluation of the absorption and disposition in the body of a generic formulation of darifenacin 15 mg against the innovator product in healthy fed volunteers.Bioequivalence assessment between two formulations of darifenacin 15 mg.Other - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12610000894099Center for Clinical Pharmacology Research Bdbeq S.A.24
Completed
Phase 1
Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients.AsthmaNCT01494610GlaxoSmithKline60
Active, not recruiting
Phase 1
A study in healthy people to compare 2 different formulations of nerandomilast tablets when taken with or without foodHealthy volunteer trialTherapeutic area: Not possible to specifyCTIS2024-511245-18-00Boehringer Ingelheim International GmbH15