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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05907954
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

IDEAYA Biosciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jasgit Sachdev, MD
Principal Investigator Affiliation IDEAYA Biosciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, France, Germany, Italy, Netherlands, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Uveal Melanoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: darovasertib

IDE196 (darovasertib) oral open label

Interventions

Drug: - Darovasertib

Oral, potent, selective inhibitor of Protein Kinase C

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

HonorHealth Research Institute, Scottsdale, Arizona

Status

Recruiting

Address

HonorHealth Research Institute

Scottsdale, Arizona, 85258

UCLA Medical Center, Los Angeles, California

Status

Recruiting

Address

UCLA Medical Center

Los Angeles, California, 90024

Site Contact

Adyel Annelus

[email protected]

310-794-4955

Stanford Cancer Institute, Palo Alto, California

Status

Recruiting

Address

Stanford Cancer Institute

Palo Alto, California, 94305

Site Contact

Claire A Billman, B.S

[email protected]

650-736-6425

Sarah Cannon Research Institute, Denver, Colorado

Status

Recruiting

Address

Sarah Cannon Research Institute

Denver, Colorado, 80218

Site Contact

Sarah Cannon

[email protected]

720-754-2610

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33146

Site Contact

Clinical Trials Group

[email protected]

1 650-534-3616

The Cancer and Hematology Centers, Grand Rapids, Michigan

Status

Recruiting

Address

The Cancer and Hematology Centers

Grand Rapids, Michigan, 49546

Site Contact

The Cancer and Hematology Centers of Western Michigan

[email protected]

616-954-5550

Northwell, Manhasset, New York

Status

Recruiting

Address

Northwell

Manhasset, New York, 11030

Site Contact

Leila Nasr, BS

[email protected]

646-785-8203

Duke University Health System, Durham, North Carolina

Status

Recruiting

Address

Duke University Health System

Durham, North Carolina, 27710

Site Contact

Carol Ann Wiggs, BSN

[email protected]

919-684-0281

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Marlana Orloff, MD

[email protected]

215-955-9980

Sarah Cannon Research Institute, Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Site Contact

Ask Sarah

[email protected]

844-482-4812

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

James Harbour, MD

[email protected]

214-648-3407

International Sites

St. Vincent's Health Sydney, Sydney, New South Wales, Australia

Status

Recruiting

Address

St. Vincent's Health Sydney

Sydney, New South Wales, 2010

Alfred Health, Melbourne, Victoria, Australia

Status

Recruiting

Address

Alfred Health

Melbourne, Victoria, 3004

Site Contact

Chris Brooks

[email protected]

1 650-534-3616

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9

Site Contact

Marcus Butler, MD

[email protected]

416-946-4501 #5485

Institute Curie, Paris, France

Status

Not yet recruiting

Address

Institute Curie

Paris, ,

Charite Comprehensive Cancer Center, Berlin, Germany

Status

Not yet recruiting

Address

Charite Comprehensive Cancer Center

Berlin, , D-10117

Essen, Germany

Status

Not yet recruiting

Address

University Hospital Essen - West German Cancer Center

Essen, , 45147

Instituto Nazionale Tumori di Milano, Milano, Italy

Status

Not yet recruiting

Address

Instituto Nazionale Tumori di Milano

Milano, , 20133

Naples, Italy

Status

Not yet recruiting

Address

Instituto Nazionale Tumori IRCCS - Fondazione Pascale

Naples, , 80131

Rome, Italy

Status

Not yet recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , 00168

Leiden University Medical Center, Leiden, Netherlands

Status

Recruiting

Address

Leiden University Medical Center

Leiden, , 2333 ZA

The Clatterbridge Cancer Centre NHS FT, Liverpool, United Kingdom

Status

Not yet recruiting

Address

The Clatterbridge Cancer Centre NHS FT

Liverpool, , L7 8YA

London, United Kingdom

Status

Not yet recruiting

Address

University College London Hospital - NHS Foundation Trust

London, , NW1 2PG

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