A Phase I clinical trial to investigate the safety and tolerability of NK105 when co-administered with carboplatin once per week to Japanese patients with advanced solid cancers.
- Conditions
- Advanced solid cancers
- Registration Number
- JPRN-jRCT2080223202
- Lead Sponsor
- ippon Kayaku Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
A solid cancer has been confirmed by tissue and/or cytological diagnosis.
There is no standard therapy, or even if available, the cancer was refractory to it or it was intolerable to the patient.
ECOG Performance Status of 0-1.
Grade >=2 sensory neuropathy.
Use of any other therapeutic agents within 28 days prior to enrollment.
A history of drug hypersensitivity requiring systemic treatment, such as anaphylaxis, etc., or a history of hypersensitivity to carboplatin formulations or conventional paclitaxel formulations.
A complication of heart failure or ischemic heart disease (Class 2 or higher in the NYHA cardiac function classification), or a need for new treatment within 6 months before enrollment.
Use of a systemic antimicrobial to treat an infection within 14 days prior to enrollment.
Presence of pleural effusion, ascites or cardiac effusion for which drainage is considered necessary.
Presence of CNS metastasis accompanied by symptoms.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Pharmacokinetics<br>Efficacy