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Clinical trial

Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

ID
Name
LTS17660
Description
Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213
Trial arms
Trial start
2022-02-23
Estimated PCD
2024-07-10
Trial end
2024-07-10
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Belumosudil 200 mg QD
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Arms:
Arm A: belumosudil 200 mg QD
Other names:
REZUROCK
Belumosudil 200 mg BID
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Arms:
Arm B: belumosudil 200 mg BID
Other names:
REZUROCK
Belumosudil 400 mg QD
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Arms:
Arm C: belumosudil 400 mg QD
Other names:
REZUROCK
Size
23
Primary endpoint
Adverse Events
3 years
Duration of Response
3 years
Failure Free Survival
3 years
Eligibility criteria
Inclusion Criteria: Subjects must have been treated with belumosudil for at least 1 of the following: * Actively receiving belumosudil on Study KD025-208 or Study KD025-213 * Is in Long-term Follow-up (LTFU) on Study KD025-208 or Study KD025-213. Long-term Follow-up will be defined as the period after ending treatment with belumosudil and until a FFS event occurs. * Adult enrolled in the Companion Study under KD025-213 Amendment 2 (01 June 2020) and has received at least 6 months of treatment of belumosudil or is in LTFU Exclusion Criteria: * Female subject who is pregnant or breastfeeding * Subject considered unlikely to adhere to treatment and/or follow protocol in the opinion of the Investigator
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2023-08-25

1 organization

1 product

1 indication

Product
Belumosudil
Indication
Chronic Graft-versus-host disease
Organization
Kadmon