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Trial record 1 of 1 for:    NCT02043288
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Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

This study is currently recruiting participants.
Verified November 2016 by Orient Europharma Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02043288
First Posted: January 23, 2014
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
NanoCarrier Co., Ltd.
Information provided by (Responsible Party):
Orient Europharma Co., Ltd.
  Purpose
This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countires.

Condition Intervention Phase
Pancreatic Neoplasms Drug: NC-6004 Drug: Gemcitabine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Orient Europharma Co., Ltd.:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 3.5 years ]
    Overall survival is defined as the time from the treatment initiation until death from any cause, and censored at the last follow up time.


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 3.5 years ]
    Progression free survival is defined as the time from the treatment initiation until progression or death, and censored at the last follow up time.

  • Response rate (RR) and disease control rate (DCR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria [ Time Frame: 3.5 years ]
    • Response rate is defined as counts and proportions of patients responding complete response or partial response within the duration of the study.
    • Disease control rate is defined as counts and proportions of patients responding complete response, partial response or progressive disease within the duration of the study.

  • Duration of response [ Time Frame: 3.5 years ]
    • Duration of overall response (DOR) will be measured from the time of initial response (CR or PR) until documented progression or death, and censored at last follow up time.
    • Duration of stable disease (DSD) will be measured from the time of initial stable disease (SD) until documented progression or death, and censored at last follow up time.

  • CA19-9 [ Time Frame: 3.5 years ]
    CA19-9 values and changes from baseline will be summarized.

  • Quality of life (QoL) using EORTC QLQ-C30 [ Time Frame: 3.5 years ]
    Quality of life (QoL) values and changes from baseline will be summarized.

  • exploratory objective [ Time Frame: 3.5 years ]
    Pharmacokinetic profile , such as Cmax, Tmax, T1/2 and AUC


Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NC-6004 and Gemcitabine combination
90mg/m2 i.v. on Day 1 and 1000mg/m2 i.v. on Day 1, 8 and 15 respectively
Drug: NC-6004

Study group (3 week/cycle):

NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1

Other Name: Micelplatin
Drug: Gemcitabine

Study group (3 week/cycle):

Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004)

Control group (4 week/cycle):

Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15

Other Name: Gemzar
Active Comparator: Gemcitabine monotherapy
1000mg/m2 i.v. on Day 1 ,8 and 15
Drug: Gemcitabine

Study group (3 week/cycle):

Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004)

Control group (4 week/cycle):

Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15

Other Name: Gemzar

Detailed Description:

Pancreatic cancer is one of the most deadly cancers because of the predominately late diagnosis. Gemcitabine (GEM) is the standard treatment for advanced and metastatic pancreatic cancer. According to preclinical data and few early phase studies, a combined use of gemcitabine and cisplatin (CDDP) showed synergistic efficacy against pancreatic cancer. NC-6004, a novel micellar cisplatin formulation, retains the activity but avoids the renal toxicity and neurotoxicity caused by the high peak Cmax concentrations of cisplatin. This trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer.

The main hypothesis of this study is that NC-6004 plus gemcitabine combination is superior to gemcitabine alone in terms of overall survival in locally advanced or metastatic pancreatic cancer patients

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged between 20 to 80 years (inclusive)
  2. Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer (adenocarcinoma, adenosquamous carcinoma or poorly differentiated carcinoma)
  3. Presence of at least one measurable tumor lesion (longest diameter ≥ 10 mm)
  4. No prior systemic anti-cancer therapy and radiotherapy for advanced pancreatic cancer
  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  6. Adequate organ function defined as:

    • 3,000 cells/μL ≤ White blood cell count (WBC) ≤ 12,000 cells/μL
    • Absolute neutrophils count (ANC) ≥ 1,500 cells/μL
    • Platelets ≥ 100,000 cells/μL
    • Hemoglobin (Hb) ≥ 9.0 g/dL
    • Alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤ 2.5 times the upper limit of normal (ULN) in patients with no demonstrable hepatic metastasis, or ≤ 5 x ULN in patients with hepatic metastasis
    • Serum bilirubin ≤ 1.5 x ULN in patients with no demonstrable hepatic metastasis and obstructive jaundice, or ≤ 2.5 x ULN in patients with hepatic metastasis or obstructive jaundice
    • Serum creatinine (SCr) ≤ 1.5 mg/dL and creatinine clearance (CrCl) ≥ 60 mL/min (from 24-hour urine test or Cockcroft-Gault formula)
    • Corrected serum calcium ≤ ULN
  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:

  1. Pregnancy or breastfeeding
  2. Active concomitant malignancy or history of other cancer except carcinoma in situ of cervical squamous cell carcinoma, stage I colon cancer or other malignance that has remained disease-free for more than 3 years after curative intervention
  3. Metastasis to the central nervous system or brain
  4. Evidence of hearing impaired ≥ Grade 2 as assessed by pure tone audiometry or other neurotoxicity ≥ Grade 2
  5. 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. Severe mental disorder
  10. As judged by the investigator, any evidence of significant laboratory findings or severe/uncontrolled clinical disorders (e.g. dementia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, and other unstable or uncompensated respiratory, cardiac, hepatic, renal and/or infectious disease)
  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043288


Contacts
Contact: I-Chan Lee, COM +886-2-27554881 ext 2928 IChan.lee@oppharma.com

  Show 46 Study Locations
Sponsors and Collaborators
Orient Europharma Co., Ltd.
NanoCarrier Co., Ltd.
Investigators
Principal Investigator: Li-Tzong Chen, M.D., Ph. D. National Institute of Cancer Research, National Health Research Institutes
  More Information

Responsible Party: Orient Europharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02043288     History of Changes
Other Study ID Numbers: NC-6004-005
First Submitted: January 14, 2014
First Posted: January 23, 2014
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Orient Europharma Co., Ltd.:
Pancreatic cancer
Platinum
Micelle

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs