Patients with Locally Advanced or Metastatic Pancreatic Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : NC-6004
INN of investigational material : NC-6004
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational ma
Sponsors
NanoCarrier Co., Ltd.
Orient EuroPharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged between 20 to 80 years 2) Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer 3) Presence of at least one measurable tumor lesion 4) No prior systemic anti-cancer therapy and radiotherapy for advanced pancreatic cancer 5) Eastern Cooperative Oncology Group performance status of <= 1 6) Adequate organ function 7) If fertile, willing to use barrier contraception till 6 months after the end of treatment 8) Willing and able to comply with study procedures and provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Pregnancy or breastfeeding 2) Active concomitant malignancy or history of other cancer 3) Metastasis to the central nervous system or brain 4) Evidence of hearing impaired >= Grade 2 5) Patient with pulmonary fibrosis or interstitial pneumonia 6) Marked pleural effusion or ascites above Grade 2 7) Patient with known HIV infection 8) Patient with active hepatitis B, hepatitis C or any other ongoing severe infections 9) Patient with severe mental disorder 10) As judged by the investigator, any evidence of significant laboratory findings or severe/uncontrolled clinical disorders 11) Patient with known hypersensitivity to Pt compounds 12) Known severe drug hypersensitivity 13) Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment 14) Alcoholic liver disease or liver disease with obvious clinical symptom or sign 15) Daily Alcohol consumption within 6 months before the screening 16) Patient with uncontrolled diabetes 17) Radiotherapy within 6 months before screening 18) Experienced Abdominal Radiotherapy 19) Experienced treatment of Gemtuzumab ozogamicin 20) Patient with autoimmune hepatitis or idiopathic thrombocytopenic purpura 21) Observation of "attenuated or reversed hepatic venous portal blood flow" was confirmed by doppler ultrasonography or CT of the liver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Progression free survival, objective response rate, duration of response, change in tumor biomarker, quality of life, safety and tolerability profile | — |
Countries
Asia except Japan, Japan
Outcome results
None listed