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NCT03143491
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)
Phase 2 trial testing SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment in Cervical Intraepithelial Neoplasia. Withdrawn.
1 December 2018
Quick facts
| Lead sponsor | DFB Soria, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 October 2017 |
| Primary completion | 1 December 2018 |
| Estimated completion | 1 March 2019 |
Drugs / interventions tested
- SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment — full drug profile →
Conditions studied
- Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →
Sponsor
DFB Soria, LLC — full company profile →
Who can join
18 and older, female only, with Cervical Intraepithelial Neoplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03143491
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
Trials testing the same drug.
- NCT03083470 — Study of SOR007 Ointment for Actinic Keratosis · Phase 2 · completed
Other recruiting trials for Cervical Intraepithelial Neoplasia
Currently open trials in the same condition.
- NCT07275333 — Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine · NA · recruiting
- NCT06815939 — Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer · NA · recruiting
- NCT06810427 — A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings · NA · active not recruiting
- NCT06191133 — Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma · Phase 1 · recruiting
- NCT06243666 — Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls · active not recruiting
Other DFB Soria, LLC trials
Trials by the same sponsor.
- NCT03083470 — Study of SOR007 Ointment for Actinic Keratosis · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03143491 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by DFB Soria, LLC
- Last refreshed: 18 October 2017
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/NCT03143491.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing