A PHASE I STUDY OF PRALSETINIB IN PATIENTS WITH RET ALTERED SOLID TUMOR

JRCT ID: jRCT2031210144

Registered date:11/06/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: RET altered solid tumor
• Date of first enrollment: 20/07/2021
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Pralsetinib will be administered orally, once daily at a dose of 400 mg.

Outcome(s)

Primary Outcome

safety, phamacokinetics
Dose limiting toxicity
Safety
Pharmacokinetics

Secondary Outcome

efficacy
Efficacy based on RECIST v1.1
Relationship between RET alteration and efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Histologically or cytologically documented solid tumors
ECOG PS of Grade 0 or 1
RET alteration has been identified
Advanced or recurrent cancer for which standard therapy is ineffective or for which no standard therapy exists

Exclude criteria

Other than RET alteration, known major driver mutations have been identified
There has been a history of administration of other selective RET inhibitors

Related Information

• Primary Sponsor: Yanagitani Noriko