MedPath

Repotrectinib

Generic Name
Repotrectinib
Drug Type
Small Molecule
Chemical Formula
C18H18FN5O2
CAS Number
1802220-02-5
Unique Ingredient Identifier
08O3FQ4UNP
Indication

用于ROS1阳性的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。

Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC

Phase 2
Recruiting
Conditions
NSCLC Stage IV
NSCLC, Stage III
Interventions
First Posted Date
2024-08-13
Last Posted Date
2025-01-22
Lead Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Target Recruit Count
30
Registration Number
NCT06552234
Locations
🇫🇷

CH Aix-en-Provence, Aix-en-Provence, Bouches Du Rhône, France

🇫🇷

AP-HM, Marseille, Bouches Du Rhône, France

🇫🇷

HIA Sainte Anne, Toulon, Var, France

and more 17 locations

A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants

Phase 1
Recruiting
Conditions
Healthy Volunteers
Interventions
First Posted Date
2024-07-10
Last Posted Date
2025-03-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
32
Registration Number
NCT06493409
Locations
🇺🇸

Fortrea - Daytona Beach, Daytona Beach, Florida, United States

Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

Phase 2
Recruiting
Conditions
Hormone Receptor-positive Human Epidermal Growth Factor 2-negative
Metastatic Invasive LObular Carcinoma
Interventions
First Posted Date
2024-05-10
Last Posted Date
2025-03-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
58
Registration Number
NCT06408168
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Phase 1
Recruiting
Conditions
Hepatic Impairment
Healthy Volunteers
Interventions
First Posted Date
2024-04-08
Last Posted Date
2024-07-11
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
24
Registration Number
NCT06352528
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

Local Institution - 0005, Orlando, Florida, United States

🇺🇸

Local Institution - 0006, Miami Lakes, Florida, United States

and more 3 locations

REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis

Phase 2
Recruiting
Conditions
NSCLC
Brain Metastases
ROS1 Gene Rearrangement
Interventions
First Posted Date
2024-03-18
Last Posted Date
2025-05-21
Lead Sponsor
MedSIR
Target Recruit Count
20
Registration Number
NCT06315010
Locations
🇦🇹

Medical University of Vienna, Vienna, Austria

🇪🇸

Hospital Clínico Universitario de Valencia, Valencia, Spain

🇪🇸

Hospital General Universitario Dr. Balmis, Alicante, Spain

and more 1 locations

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Phase 3
Recruiting
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2023-11-20
Last Posted Date
2025-05-18
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
190
Registration Number
NCT06140836
Locations
🇺🇸

Local Institution - 0136, Augusta, Georgia, United States

🇺🇸

Local Institution - 0221, Des Moines, Iowa, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 141 locations

Expanded Access for Repotrectinib

First Posted Date
2023-07-03
Last Posted Date
2023-07-03
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT05926232

A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors

Phase 1
Withdrawn
Conditions
Advanced Solid Tumor
Metastatic Solid Tumor
Interventions
First Posted Date
2023-04-25
Last Posted Date
2025-04-01
Lead Sponsor
Turning Point Therapeutics, Inc.
Target Recruit Count
12
Registration Number
NCT05828303
Locations
🇺🇸

Local Institution - 2101, Canton, Ohio, United States

🇺🇸

Gabrail Cancer Research Center, Canton, Ohio, United States

🇦🇺

Local Institution - 2119, Westmead, New South Wales, Australia

and more 30 locations

A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

Phase 1
Withdrawn
Conditions
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Interventions
First Posted Date
2023-04-25
Last Posted Date
2023-09-26
Lead Sponsor
Turning Point Therapeutics, Inc.
Registration Number
NCT05828277
Locations
🇪🇸

Local Institution - 4103, Madrid, Spain

🇺🇸

Gabrail Cancer Research Center, Canton, Ohio, United States

A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors

Phase 1
Terminated
Conditions
KRAS Mutation-Related Tumors
Advanced Solid Tumor
Metastatic Solid Tumor
Interventions
First Posted Date
2021-10-08
Last Posted Date
2024-04-02
Lead Sponsor
Turning Point Therapeutics, Inc.
Target Recruit Count
9
Registration Number
NCT05071183
Locations
🇺🇸

Local Institution - 2107, Houston, Texas, United States

🇺🇸

Local Institution - 2102, Virginia Beach, Virginia, United States

🇺🇸

Local Institution - 2101, California City, California, United States

and more 3 locations
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