Advanced solid cancers
Conditions
Sponsors
Nippon Kayaku Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Efficacy | — |
Outcome results
None listed