Translational research: A phase I study of niraparib and pimitespib in patients with solid tumor

JRCT ID: jRCT1030220300

Registered date:27/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: unresectable recurrent solid tumor
• Date of first enrollment: 27/08/2022
• Target sample size: 48
• Study type: Observational

Outcome(s)

• Primary Outcome: Correlation of objective response rate or disease control rate with biomarkers
• Secondary Outcome: Progression-free survival, duration of response, duration of treatment success, correlation of biomarkers with overall survival, etc.

Key inclusion & exclusion criteria

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

Include criteria

1) Willing to participate in the "A phase I study of niraparib and pimitespib in patients with solid tumor (jRCT2031220179)".
2) Written consent has been obtained from the patient for this ancillary study.
3) Age 18 years or older on the date consent is obtained.

• Exclude criteria: 1) Patients who are regarded as inappropriate for enrollment by investigators.

Related Information

• Primary Sponsor: Naito Yoichi
• Source(s) of Monetary Support: Takeda Pharmaceutical Co., Ltd.,Taiho Pharmaceutical Co., Ltd.