Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

NCT02043288 | Completed Phase 3 DMC

• 1 other identifier: NC-6004-005
• Study Type: interventional
• Target: 310
• Locations: 7 countries
• Sites: 43

Brief Summary

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 countries.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic cancer; Platinum; Micelle

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival is defined as the time from the treatment initiation until death from any cause, and censored at the last follow up time.

  3.5 years

Secondary Outcomes (5)

• Progression free survival (PFS)

  3.5 years

• Response rate (RR) and disease control rate (DCR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

  3.5 years

• Duration of response

  3.5 years

• CA19-9

  3.5 years

• Quality of life (QoL) using EORTC QLQ-C30

  3.5 years

Study Arms (2)

NC-6004 and Gemcitabine combination

EXPERIMENTAL

NC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively

Drug: NC-6004; Drug: Gemcitabine

Gemcitabine monotherapy

ACTIVE COMPARATOR

Gemcitabine 1000mg/m2 i.v. on Day 1 ,8 and 15

Drug: Gemcitabine

Interventions

NC-6004 DRUG

Study group (3 week/cycle): NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1

Also known as: Micelplatin

NC-6004 and Gemcitabine combination

Gemcitabine DRUG

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

Also known as: Gemzar

Gemcitabine monotherapy; NC-6004 and Gemcitabine combination

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 20 to 80 years (inclusive)
• Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer (adenocarcinoma, adenosquamous carcinoma or poorly differentiated carcinoma)
• Presence of at least one measurable tumor lesion (longest diameter ≥ 10 mm)
• No prior systemic anti-cancer therapy\* and radiotherapy\*\* for advanced pancreatic cancer
• \* Patients with post-operative adjuvant chemotherapy other than platinum products (e.g. cisplatin, carboplatin and oxaliplatin, etc.) or radiotherapy or chemo-radiotherapy completed more than 6 months before recurrence will be eligible.
• \*\* Patients with prior palliative radiotherapy of \< 20% bone marrow involvement prior to 6 months from screening will be eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Adequate organ function defined as:
• ,000 cells/μL ≤ 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)

You may not qualify if:

• Pregnancy or breastfeeding
• 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
• Metastasis to the central nervous system or brain
• Evidence of hearing impaired ≥ Grade 2 as assessed by pure tone audiometry or other neurotoxicity ≥ Grade 2
• \* Patients with age-associated hearing loss at the high frequencies that, in the judgment of the investigator, would not interfere significantly with patient's safety or study assessments will be eligible to enroll.
• Patient with pulmonary fibrosis or interstitial pneumonia
• Marked pleural effusion or ascites above Grade 2
• Patient with known HIV infection
• Patient with active hepatitis B, hepatitis C or any other ongoing severe infections
• Patient with severe mental disorder
• 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)
• Patient with known hypersensitivity to Pt compounds
• Known severe drug hypersensitivity
• Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment
• Alcoholic liver disease\* or liver disease with obvious clinical symptom or sign

Sponsors & Collaborators

• Orient Europharma Co., Ltd.: lead
• NanoCarrier Co., Ltd.: collaborator

Study Sites (43)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Aichi Cancer Center

Aichi, Japan

Location

Chiba Cancer Center

Chiba, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Location

Hokkaido University Hospital

Hokkaido, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Japan

Location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan

Location

Saitama Cancer Center

Saitama, Japan

Location

National Hospital Organization Shikoku Cancer Center

Shikokuchūō, Japan

Location

Shizuoka Cancer Center

Shizuoka, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, Japan

Location

Kyorin university Hospital

Tokyo, Japan

Location

National Cancer Center Hospital East

Tokyo, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Location

The University of Tokyo Hospital

Tokyo, Japan

Location

Kanagawa Cancer Center

Yokohama, Japan

Location

Hospital Sultan Ismail

Johor Bahru, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Location

Makati Medical Center

Makati, 1229, Philippines

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

Ajou University Hospital (AUH)

Gyeonggi-do, 443-380, South Korea

Location

Samsung Medical Center (SMC)

Seoul, 135-710, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital (CUK SSMH)

Seoul, 137-701, South Korea

Location

Korea University Guro Hospital (KUGH)

Seoul, 152-703, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 50-1, South Korea

Location

Chiayi Chang Gung Memorial Hospital

Chiayi City, 61363, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40750, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Chi Mei Hospital

Tainan, 710, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

National Taiwan University Hospital

Taipei, 106, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 112, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Taipei Medical University-Shuang-Ho Hospital, Ministry of Health and Welfare

Taipei, 235, Taiwan

Location

Chang Gung Memorial Hospital, Linkou Branch

Taipei, 333, Taiwan

Location

Chi Mei Medical Center

Yongkang District, 710, Taiwan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

demplatin pegraglumer; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Li-Tzong Chen, M.D., Ph. D.

  National Institute of Cancer Research, National Health Research Institutes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); SG (1); MY (2); JP (16); KR (5); HK (2); TW (16)