JPRN-jRCT2080223202
Unknown
Phase 1
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.
ippon Kayaku Co., Ltd.0 sites18 target enrollmentMay 18, 2016
ConditionsAdvanced solid cancers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced solid cancers
- Sponsor
- ippon Kayaku Co., Ltd.
- Enrollment
- 18
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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