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

I

Ideaya Biosciences

Status and phase

Enrolling
Phase 2

Conditions

Uveal Melanoma

Treatments

Drug: Darovasertib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05907954
IDE196-009

Details and patient eligibility

About

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Full description

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Enrollment

82 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

82 participants in 1 patient group

darovasertib
Experimental group
Description:
IDE196 (darovasertib) oral open label
Treatment:
Drug: Darovasertib

Trial contacts and locations

23

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Central trial contact

Jasgit Sachdev, MD; IDEAYA Clinical Trials

Data sourced from clinicaltrials.gov

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