ONO-7702/7703-03:NO-7702/ONO-7703 Phase2 Study

JRCT ID: jRCT2011200018

Registered date:18/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Radically unresectable BRAF V600-mutant thyroid cancer
• Date of first enrollment: 26/03/2021
• Target sample size: 19
• Study type: Interventional
• Intervention(s): ONO-7702 will be administered orally once daily in combination with ONO-7703 twice daily.

Outcome(s)

• Primary Outcome: Objective Response rate (central review)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age >= 20 years
2. histologically diagnosed radically unresectable locally advanced or distant metastatic thyroid cancerars
3. positive BRAF V600 mutation
4. ECOG Performance Status of 0 or 1
5. Able to swallow, ingest, and absorb oral drugs

Exclude criteria

1. Prior treatment with any RAF inhibitor or MEK inhibitor
2. symptomatic brain metastasis, leptomeningeal disease, or other active central nervous system (CNS) metastasis

Related Information

• Primary Sponsor: Hirashima Yoshinori