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
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
Nov. 27, 2020
No
version:
date:
NanoCarrier Co., Ltd.
https://www.nanocarrier.co.jp/en/contact/
NanoCarrier Co., Ltd.
https://www.nanocarrier.co.jp/en/contact/
completed
Feb. 18, 2014
310
Interventional
A Phase III, Open-label, Randomized Study
treatment purpose
3
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
20age old over
80age old under
Both
Patients with Locally Advanced or Metastatic Pancreatic Cancer
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 material : NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1
Generic name etc : Gemcitabine
INN of investigational material : Gemcitabine
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : GEM 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8
control material(s)
Generic name etc : Gemcitabine
INN of investigational material : Gemcitabine
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : GEM 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15
efficacy
Overall survival
safety
efficacy
Progression free survival, objective response rate, duration of response, change in tumor biomarker, quality of life, safety and tolerability profile
NanoCarrier Co., Ltd.
Orient EuroPharma Co., Ltd.
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National Cancer Center Hospital Institutional Review Board
