A Phase III, Open-label, Randomized Study of the Combination Therapy with NC-6004 and Gemcitabine versus Gemcitabine Alone in Patients with Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Patients with Locally Advanced or Metastatic Pancreatic Cancer
- Registration Number
- JPRN-jRCT2080223564
- Lead Sponsor
- anoCarrier Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 310
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall survival
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Progression free survival, objective response rate, duration of response, change in tumor biomarker, quality of life, safety and tolerability profile