CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Liquid 13-Cis Retinoic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03291080
NCT03291080Phase 2Completed

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.

Nova Laboratories Limited·interventional·Posted Sep 25, 2017·Updated Oct 19, 2021

In Brief

A Phase 2 clinical trial evaluating Liquid 13-Cis Retinoic Acid and Extracted capsules 13-CRA for Neuroblastoma. Completed, enrolled 20 participants across 10 sites.

Detailed Summary

An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - \< 21 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 25, 2017
Enrollment StartApr 17, 2018
Primary CompletionSep 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.8 years ago

Interventions

Liquid 13-Cis Retinoic Aciddrug

Liquid 13-Cis Retinoic Acid

Extracted capsules 13-CRAdrug

Extracted capsules 13-CRA