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Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors

Type d'étude Promoteur Etat actuel de l'étude

Interventionnelle

Boston Pharmaceuticals En cours de recrutement

 

Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors

Code de l’étude

NCT03780517

Promoteur

Boston Pharmaceuticals

Tumeur éligible

RET-altered Non Small Cell Lung Cancer, RET altered Medullary Thyroid Cancer

Type d’étude

Interventionnelle

Phase

1

Nombre de patients à inclure

114 participants

Contact

   BOS172738-01@precisionformedicine.com

Centres

France: Institut Gustave Roussy, Institut Bergonié (bordeaux), Belgique, Espagne

Objectifs

Number of participants with any treatment-emergent serious adverse event, with any non-serious TEAE, with grade 3, grade 4, or grade 5 TEAEs, with any related TEAE, with any TEAE leading to study drug discontinuation

Maximum tolerated dose

Recommended phase 2 dose

Objective Response Rate, Objective Disease Control Rate, Progression-Free Survival, Duration of Response Time to Response, Duration of Complete Response

Critères d’inclusion

•    Male or female participants must be ? 18 years, at the time of signing the informed consent
•    Diagnosis of advanced solid tumor with a documented rearranged during transfection (RET) gene altered malignancy as determined locally by a DNA based assay of tumor tissue and/or blood
•    Participants must have no alternative approved therapy.
•    For participants in Part B expansion cohort only: documented local diagnosis of either 1) advanced RET gene fusion non-small cell lung cancer (NSCLC); 2) advanced RET gene mutant medullary thyroid cancer (MTC); or 3) other RET gene altered advanced tumors or NSCLC/MTC with prior specific RET gene targeted therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•    Negative pregnancy test for females of child bearing potential; must be surgically sterile, postmenopausal, or willing and able to be compliant with a contraceptive regimen
•    Contraceptive use by men or women should be consistent with local regulations.
•    Capable of giving signed informed consent

Critères d’exclusion

•    Inability to take oral medications or gastrointestinal (GI) conditions that can interfere with the swallowing or absorption of study medication
•    Uncontrolled or severe concurrent medical condition
•    History of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug
•    Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug
•    Participants with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required)
•    Participants who are hepatitis B surface antigen positive or participants who are hepatitis C antibody positive (Participants who have been successfully treated for hepatitis C virus [HCV] are eligible if an undetectable HCV viral load at least 6 months after completion of treatment can be demonstrated.)
•    Any evidence of serious active infections
•    Uncontrolled or severe cardiovascular disease
•    Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
•    Participants with a prior or concurrent malignancy other than the malignancies under study ongoing cancer directed therapy