NCT04428879 (STEP-RB) is a Phase 1 clinical trial of Topotecan Episcleral Plaque in Retinoblastoma, sponsored by The Hospital for Sick Children.

Who is sponsoring NCT04428879?

NCT04428879 is sponsored by The Hospital for Sick Children.

What drugs are being tested in NCT04428879?

Interventions in NCT04428879: Topotecan Episcleral Plaque.

What condition does NCT04428879 study?

NCT04428879 studies Retinoblastoma.

Is NCT04428879 still recruiting?

NCT04428879 is currently completed. Last updated 13 December 2024.

Last reviewed 2024-12-13 · How we verify

NCT04428879: STEP-RB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Topotecan Episcleral Plaque for Treatment of Retinoblastoma

Completed Phase 1 Last updated 13 December 2024

What this trial tests

Phase 1 trial testing Topotecan Episcleral Plaque in Retinoblastoma in 26 participants. Completed in 3 October 2024.

Timeline

16 June 2020

Primary endpoint
1 October 2024

3 October 2024

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	16 June 2020
Primary completion	1 October 2024
Estimated completion	3 October 2024
Sites	1 location across Canada

Drugs / interventions tested

Topotecan Episcleral Plaque — full drug profile →

Conditions studied

Retinoblastoma — all drugs for Retinoblastoma →

Sponsor

The Hospital for Sick Children

Who can join

Under 17, any sex, with Retinoblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This single site, single-arm, non-randomized, dose escalation phase I toxicity clinical trial will assess primarily the safety and secondarily the efficacy of episcleral topotecan in patients with active de novo or residual or recurrent intraocular retinoblastoma in at least one eye following completion of first-line therapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Retinoblastoma: An update on genetic origin, classification, conventional to next-generation treatment strategies.
Pareek A, Kumar D, Pareek A, Gupta MM, et al · · 2024 · cited 10× · PMID 38975183 · DOI 10.1016/j.heliyon.2024.e32844
Children's Oncology Group's 2023 blueprint for research: Rare tumors.
Schultz KAP, Chintagumpala M, Piao J, Chen KS, et al · · 2023 · cited 5× · PMID 37458616 · DOI 10.1002/pbc.30574

Verify or expand the search:

Other recruiting trials for Retinoblastoma

Currently open trials in the same condition.

NCT06725173 — Detailed Phenotypic and Genotype Study to Correlate RB1 Mutations Relating to Primary Ocular Tumors and Secondary Extra- · recruiting
NCT06972602 — High-dose Topotecan for Retinoblastoma With Recurrent or Refractory Vitreous Seed · EARLY_PHASE1 · recruiting
NCT06424301 — Targeting NUDT21 siRNA Drugs for Patients With Refractory Retinoblastoma · EARLY_PHASE1 · recruiting
NCT06367530 — Trilateral Retinoblastoma: Incidence and Outcomes · recruiting
NCT05650749 — GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma · Phase 1 · recruiting

Other The Hospital for Sick Children trials

Trials by the same sponsor.

NCT07454681 — MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure . · not yet recruiting
NCT07452575 — 3D Ultrasound in Hemophilic Ankles · NA · not yet recruiting
NCT07508826 — AI-assisted Endotracheal Intubation · NA · not yet recruiting
NCT07345819 — Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis · NA · not yet recruiting
NCT07497178 — MRgFUS for Childhood Epilepsy · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04428879 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Hospital for Sick Children
Last refreshed: 13 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04428879.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing