Expanded Access Program of ONO-7702/ONO-7703 (ONO-7702/7703-03E)

JRCT ID: jRCT2011230032

Registered date:23/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Radically unresectable BRAF V600-mutant thyroid cancer
• Date of first enrollment: 30/09/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): ONO-7702 will be administered orally once daily in combination with ONO-7703 twice daily.

Outcome(s)

Primary Outcome

safety
efficacy

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