Trial Title:
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
NCT ID:
NCT05907954
Condition:
Uveal Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Uveal Melanoma
Plaque brachytherapy
Enucleation
Neoadjuvant
Adjuvant
Protein Kinase C
Ophthalmology
Ocular Oncology
Darovasertib
IDE196
Ocular melanoma
Choroid melanoma
Plaque
Brachytherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Darovasertib
Description:
Oral, potent, selective inhibitor of Protein Kinase C
Arm group label:
darovasertib
Other name:
IDE196
Other name:
LXS196
Summary:
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Detailed 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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth Research Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Phone:
480-323-1791
Email:
clinicaltrials@honorhealth.com
Facility:
Name:
Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Contact:
Last name:
Catherine O'Neil
Phone:
858-822-6575
Email:
croneil@health.ucsd.edu
Contact backup:
Last name:
Jazelle Molina
Phone:
(858) 822-5354
Email:
jgmolina@health.ucsd.edu
Facility:
Name:
UCLA Medical Center
Address:
City:
Los Angeles
Zip:
90024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adyel Annelus
Phone:
310-794-4955
Email:
aannelus@mednet.ucla.edu
Contact backup:
Last name:
Elizabeth Seja
Phone:
310-794-6892
Email:
eseja@mednet.ucla.edu
Facility:
Name:
Stanford Cancer Institute
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claire A Billman, B.S
Phone:
650-736-6425
Email:
cbillman@stanford.edu
Contact backup:
Last name:
Denise Haas, MBA
Phone:
650-736-1252
Email:
dhaas@stanford.edu
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarah Cannon
Phone:
720-754-2610
Email:
cann.ddudenvergeneral@sarahcannon.com
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Group
Email:
CRSCutaneous@miami.edu
Facility:
Name:
The Cancer and Hematology Centers
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Contact:
Last name:
The Cancer and Hematology Centers of Western Michigan
Phone:
616-954-5550
Email:
ClinicalTrials@chcwm.com
Contact backup:
Last name:
Jessica Miller, RN
Phone:
616-954-5550
Phone ext:
1651
Email:
jmiller@chcwm.com
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Facility:
Name:
Northwell
Address:
City:
Manhasset
Zip:
11030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Leila Nasr, BS
Phone:
646-785-8203
Email:
lnasr@northwell.edu
Facility:
Name:
Duke University Health System
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carol Ann Wiggs, BSN
Phone:
919-684-0281
Email:
carolann.wiggs@duke.edu
Contact backup:
Last name:
Emily Bolch
Phone:
919-668-6359
Email:
emily.bolch@duke.edu
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marlana Orloff, MD
Phone:
215-955-9980
Email:
Marlana.Orloff@Jefferson.edu
Contact backup:
Last name:
Liam Hulse, BS
Phone:
215-520-5206
Email:
liam.hulse@jefferson.edu
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ask Sarah
Phone:
844-482-4812
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Harbour, MD
Phone:
214-648-3407
Email:
William.Harbour@UTSouthwestern.edu
Contact backup:
Last name:
Juan Mo, PhD
Phone:
(214) 645-3087
Email:
Juan.Mo@UTSouthwestern.edu
Facility:
Name:
St. Vincent's Health Sydney
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Recruiting
Contact:
Phone:
02 9355 5611
Email:
SVHS.CancerResearch@svha.org.au
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Chris Brooks
Email:
chr.brooks@alfred.org.au
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Melissa Dalva
Phone:
416-946-4501
Phone ext:
5485
Email:
Melissa.Dalva@uhn.ca
Facility:
Name:
Institute Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Contact:
Last name:
Sophie Piperno-Neumann, MD
Phone:
+33(0)1 44 32 40 68
Email:
sophie.piperno-neumann@curie.fr
Facility:
Name:
Charité - Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Julia Koester-Schuster
Phone:
4930450554388
Email:
studien-augenklinik-cbf@charite.de
Facility:
Name:
University Hospital Essen - West German Cancer Center
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale Tumori
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Segreteria Chirurgia Oncologica Oculare
Phone:
0039 0223903896
Email:
oncologia.oculare@istitutotumori.mi.it
Facility:
Name:
Instituto Nazionale Tumori IRCCS - Fondazione Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Contact:
Email:
melanoma.immunoterapia@istitutotumori.na.it
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ernesto Rossi
Email:
oncomedsperimentali@policlinicogemelli.it
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Ellen Kapiteijn, MD, PhD
Phone:
0031 71 5261093
Email:
H.W.Kapiteijn@lumc.nl
Facility:
Name:
University College London Hospital - NHS Foundation Trust
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Heather Shaw
Phone:
0203 447 5369
Email:
uclh.randd@nhs.net
Facility:
Name:
The Clatterbridge Cancer Centre NHS Foundation Trust
Address:
City:
Wirral
Zip:
CH63 4JY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Joseph Sacco
Phone:
0151 556 5212
Email:
j.j.sacco@liverpool.ac.uk
Start date:
July 3, 2023
Completion date:
January 31, 2029
Lead sponsor:
Agency:
IDEAYA Biosciences
Agency class:
Industry
Source:
IDEAYA Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05907954
