Extension study for HER2 amplified advanced solid tumors (JUPITER ES)

JRCT ID: jRCTs031220444

Registered date:11/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Solid tumors
• Date of first enrollment: 26/12/2022
• Target sample size: 3
• Study type: Interventional

Intervention(s)

Trastuzumab (loading dose: 8mg/kg, maintenance dose: 6mg/kg every 3 weeks)
Pertuzumab (loading dose:840mg, maintenance dose: 420mg every 3 weeks)

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Safety

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients enrolled in the Phase II study and continuing on study treatment at the time of obtaining consent for this study.
(2) Women of child-bearing potential and partners of child-bearing potentail must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for 28 weeks following completion of study therapy.
(3) Patients signed informed consent form.

Exclude criteria

(1) Patients who participated in clinical studies other than the Phase II trials within 4 weeks prior to obtaining consent for this study.
(2) Patients who have a clinically significant medical condition that makes participation in this study inadvisable or makes compliance with the requirements of this study difficult.
(3) Any other patients who are regarded as inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Ikeda Sadakatsu