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Clinical Trial Finder

Search Results

(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 5313457, Arizona 5551752

Status

Recruiting

Address

HonorHealth Research Institute

Scottsdale 5313457, Arizona 5551752, 85258

Site Contact

[email protected]

(480) 323-1791

Moores Cancer Center, La Jolla 5363943, California 5332921

Status

Recruiting

Address

Moores Cancer Center

La Jolla 5363943, California 5332921, 92093

Site Contact

Catherine O'Neil

[email protected]

(858) 822-6575

UCLA Medical Center, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

UCLA Medical Center

Los Angeles 5368361, California 5332921, 90024

Site Contact

Adyel Annelus

[email protected]

310-794-4955

Stanford Cancer Institute, Palo Alto 5380748, California 5332921

Status

Recruiting

Address

Stanford Cancer Institute

Palo Alto 5380748, California 5332921, 94305

Site Contact

Claire A Billman, B.S

[email protected]

650-736-6425

Sarah Cannon Research Institute, Denver 5419384, Colorado 5417618

Status

Recruiting

Address

Sarah Cannon Research Institute

Denver 5419384, Colorado 5417618, 80218

Site Contact

Sarah Cannon

[email protected]

720-754-2610

University of Miami, Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami

Miami 4164138, Florida 4155751, 33146

Site Contact

Clinical Trials Group

[email protected]

1 650-534-3616

The Cancer and Hematology Centers, Grand Rapids 4994358, Michigan 5001836

Status

Recruiting

Address

The Cancer and Hematology Centers

Grand Rapids 4994358, Michigan 5001836, 49546

Site Contact

The Cancer and Hematology Centers of Western Michigan

[email protected]

616-954-5550

Mayo Clinic Rochester, Rochester 5043473, Minnesota 5037779

Status

Recruiting

Address

Mayo Clinic Rochester

Rochester 5043473, Minnesota 5037779, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

Northwell, Manhasset 5125766, New York 5128638

Status

Recruiting

Address

Northwell

Manhasset 5125766, New York 5128638, 11030

Site Contact

Leila Nasr, BS

[email protected]

(646) 785-8203

Duke University Health System, Durham 4464368, North Carolina 4482348

Status

Withdrawn

Address

Duke University Health System

Durham 4464368, North Carolina 4482348, 27710

Site Contact

[email protected]

1 650-534-3616

Thomas Jefferson University, Philadelphia 4560349, Pennsylvania 6254927

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia 4560349, Pennsylvania 6254927, 19107

Site Contact

Marlana Orloff, MD

[email protected]

215-955-9980

Sarah Cannon Research Institute, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville 4644585, Tennessee 4662168, 37203

Site Contact

Ask Sarah

[email protected]

844-482-4812

Dallas 4684888, Texas 4736286

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas 4684888, Texas 4736286, 75390

Site Contact

James Harbour, MD

[email protected]

(214) 648-3407

International Sites

St. Vincent's Health Sydney, Sydney 2147714, New South Wales 2155400, Australia

Status

Recruiting

Address

St. Vincent's Health Sydney

Sydney 2147714, New South Wales 2155400, 2010

Site Contact

[email protected]

02 9355 5611

Alfred Health, Melbourne 2158177, Victoria 2145234, Australia

Status

Recruiting

Address

Alfred Health

Melbourne 2158177, Victoria 2145234, 3004

Site Contact

Chris Brooks

[email protected]

1 650-534-3616

Princess Margaret Cancer Centre, Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto 6167865, Ontario 6093943, M5G2M9

Site Contact

Melissa Dalva

[email protected]

416-946-4501 #5485

Institute Curie, Paris 2988507, France

Status

Recruiting

Address

Institute Curie

Paris 2988507, , 75005

Site Contact

Sophie Piperno-Neumann, MD

[email protected]

+33(0)1 44 32 40 68

Charité - Universitätsmedizin Berlin, Berlin 2950159, Germany

Status

Recruiting

Address

Charité - Universitätsmedizin Berlin

Berlin 2950159, , 12203

Site Contact

Julia Koester-Schuster

[email protected]

4930450554388

Essen 2928810, Germany

Status

Not yet recruiting

Address

University Hospital Essen - West German Cancer Center

Essen 2928810, , 45147

Site Contact

[email protected]

1 650-534-3616

Milan 3173435, Italy

Status

Recruiting

Address

Fondazione IRCCS Istituto Nazionale Tumori

Milan 3173435, , 20133

Site Contact

Segreteria Chirurgia Oncologica Oculare

[email protected]

0039 0223903896

Napoli 9031661, Italy

Status

Not yet recruiting

Address

Instituto Nazionale Tumori IRCCS - Fondazione Pascale

Napoli 9031661, , 80131

Site Contact

[email protected]

1 650-534-3616

Rome 3169070, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome 3169070, , 00168

Site Contact

Ernesto Rossi

[email protected]

1 650-534-3616

Leiden University Medical Center, Leiden 2751773, Netherlands

Status

Recruiting

Address

Leiden University Medical Center

Leiden 2751773, , 2333 ZA

Site Contact

Ellen Kapiteijn, MD, PhD

[email protected]

0031 71 5261093

London 2643743, United Kingdom

Status

Recruiting

Address

University College London Hospital - NHS Foundation Trust

London 2643743, , NW1 2PG

Site Contact

Heather Shaw

[email protected]

0203 447 5369

Metropolitan Borough of Wirral 7733088, United Kingdom

Status

Recruiting

Address

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral 7733088, , CH63 4JY

Site Contact

Joseph Sacco

[email protected]

0151 556 5212

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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