A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

Sponsor

Incyte Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04640025

Collaborator

(none)

100

Enrollment

Locations

Arm

63.4

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a open label mutli-center open-label study to provide continued supply of itacitinib to participants from Incyte-sponsored studies of itacitinib INCB39110-209 and INCB39110-230. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. This is referred to as the parent protocol.

Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.

Condition or Disease	Intervention/Treatment	Phase
Myelofibrosis	Drug: itacitinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.

Masking:

None (Open Label)

Masking Description:

Open Label

Primary Purpose:

Treatment

Official Title:

A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)

Actual Study Start Date :

Mar 10, 2021

Anticipated Primary Completion Date :

Jun 22, 2026

Anticipated Study Completion Date :

Jun 22, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: itacitinib Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.	Drug: itacitinib Participants will self-administer itacitinib orally using intact tablets with water and without regard to food. Other Names: INCB039110

Arm

Intervention/Treatment

Experimental: itacitinib

Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.

Drug: itacitinib

Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.

Other Names:

INCB039110

Outcome Measures

Primary Outcome Measures

Treatment Emergent Adverse Events (TEAE's) [3 years]
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
Currently tolerating treatment as defined by the parent Protocol.
Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
Willingness to avoid pregnancy or fathering children..
Ability to comprehend and willingness to sign an ICF.

Exclusion Criteria:

Able to access itacitinib therapy commercially.
Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
Pregnant or breastfeeding women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anschutz Cancer Pavilion - University of Colorado	Aurora	Colorado	United States	80045
2	Parkview Research Center	Fort Wayne	Indiana	United States	46845
3	Tennessee Oncology Blood & Marrow Transplant	Nashville	Tennessee	United States	37203
4	Texas Oncology San Antonio	San Antonio	Texas	United States	78240
5	St Paul'S Hospital	Vancouver		Canada	V6Z2A5

Sponsors and Collaborators

Incyte Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Incyte Corporation

ClinicalTrials.gov Identifier:

NCT04640025

Other Study ID Numbers:

INCB 39110-801

First Posted:

Nov 23, 2020

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Incyte Corporation

itacitinib

INCB39110

Additional relevant MeSH terms:

Primary Myelofibrosis

Study Results

No Results Posted as of Mar 10, 2022