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Clinical trial

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

ID
Name
IDE196-009
Description
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Trial arms
Trial start
2023-07-03
Estimated PCD
2026-01-31
Trial end
2029-01-31
Status
Recruiting
Phase
Early phase I
Treatment
Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C
Arms:
darovasertib
Other names:
IDE196, LXS196
Size
82
Primary endpoint
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
from first dose to last dose of adjuvant therapy, approximately 12 months
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Eligibility criteria
Inclusion Criteria: * Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy * Able to dose orally * ECOG Performance status of 0-1 * No other significant underlying ocular disease * Adequate organ function * Not pregnant/nursing or planning to become pregnant. Willing to use birth control Exclusion Criteria: * Previous treatment with a Protein Kinase C (PKC) inhibitor * Concurrent malignant disease * Active HIV infection or Hep B/C * Malabsorption disorder * Unable to discontinue prohibited medication * Impaired cardiac function or clinically significant cardiac disease * Any other condition which may interfere with study interpretation or results
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 82, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

1 product

1 abstract

1 indication

Organization
IdeaYA Biosciences
Product
Darovasertib
Indication
Uveal melanoma
Abstract
A phase 2 safety and efficacy study of neoadjuvant/adjuvant darovasertib for localized ocular melanoma.
Org: Queensland Institute of Medical Research Berghofer, Royal Victorian Eye and Ear Hospital, St. Vincent's Pathology, Terrace Eye Centre, The Alfred/Monash University,