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RO5217790

Phase 2

Cervical Intraepithelial Neoplasia | Small molecule | Oncology |Roche Holding AG|Last Updated: Aug 15, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment206

FDA Designations

No designations recorded

Clinical trial landscape

RO5217790 · 1 trial · 1 indication

Phase 2 1
NCT01022346A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) InfectionCervical Intraepithelial Neoplasia
COMPLETED206 Analytics
PHASE2COMPLETED
A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection
Cervical Intraepithelial NeoplasiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with CIN2/CIN3 associated with HPV16 single infection who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision
Month 6

Secondary Endpoints

Percentage of participants who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision
Months 6
Percentage of participants who achieved Histologic response (Defined as CIN Grade less than [<] 2), determined by evaluation of tissue derived from surgical excision
Month 6
Percentage of participants with viral clearance based on Roche Linear assay results
Months 3 and 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
RO5217790EXPERIMENTALRO5217790 will be administered at a dose of 5\*10\^7 plaque forming unit (pfu) subcutaneously on Days 1, 8, and 15.

Interventions

NameTypeDescription
PlaceboDRUGPlacebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
RO5217790DRUGRO5217790 will be administered at a dose of 5\*10\^7 pfu subcutaneously on Days 1, 8, and 15.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Have a diagnosis within 2 months prior to the first dose of RO5217790 of CIN 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual CIN2/3 disease remaining after biopsy. Entry to the trial will be allowed based on the local asses...

Countries:United StatesBelgiumFinlandFrancePuerto RicoSpain
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Frequently asked questions about RO5217790

What is RO5217790 used for?

RO5217790 is an investigational small molecule being studied for the treatment of high grade cervical intraepithelial neoplasia (CIN) associated with high risk human papillomavirus (HR-HPV) infection. It is being developed by Roche Holding AG (RHHBY) and is currently in Phase 2 clinical development.

What does RO5217790 target?

The molecular target of RO5217790 has not been disclosed. It is a small molecule being evaluated for its potential to treat cervical intraepithelial neoplasia, a precancerous condition of the cervix associated with high risk human papillomavirus infection.

Who makes RO5217790?

RO5217790 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for the treatment of cervical intraepithelial neoplasia.

What phase is RO5217790 in?

RO5217790 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is RO5217790 in?

RO5217790 has been studied in one completed Phase 2 clinical trial, NCT01022346. This randomized, double-blind, placebo-controlled study enrolled 206 female participants with high grade cervical intraepithelial neoplasia associated with high risk human papillomavirus infection.

Is RO5217790 the same as any other drug?

No alternative names for RO5217790 have been disclosed. The drug is identified solely by its development code RO5217790 in clinical trial records and is being studied for cervical intraepithelial neoplasia.