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Pancreatic NeoplasmsPhase 3NCT02043288

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

A Phase 3 study testing NC-6004 and Gemcitabine in people with Pancreatic Neoplasms, run by Orient Europharma Co., Ltd. at 43 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
NC-6004 and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
43 sitesin 7 countries
Study dates
Jan 2014to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Adequate organ function defined as:
  • 3,000 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)
  • Corrected serum calcium ≤ ULN
  • If fertile*, willing to use barrier contraception till 6 months after the end of treatment
  • With the following exceptions: 1) pre-menopausal females with bilateral tubal ligation, bilateral oophorectomy or hysterectomy; 2) post-menopausal women, defined as 12 months of spontaneous amenorrhea; 3) males with vasectomy.
  • Willing and able to comply with study procedures and provide written informed consent

Who cannot join

  • 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
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  • 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
  • the investigator should judge from medical examination by interview and laboratory test including γ-GTP, AST and ALT
  • Daily Alcohol consumption within 6 months before the screening as an average weekly intake of >21 units (168 g of pure alcohol) or an average daily intake of >3 units (24 g of pure alcohol) for males / an average weekly intake of >14 units (112 g of pure alcohol) or an average daily intake of >2 units (16 g of pure alcohol) for females.
  • Kind of Alcohol Alcohol Percentage mL per 1 unit =8 g of pure alcohol
  • Beer 5 % 200 mL
  • Whiskey/Brandy 40 % 25 mL
  • Wine 12 % approx. 83 mL
  • Sake 15 % approx. 67 mL
  • Distilled spirit 25 % 40 mL
  • Kaoliang 50 % 20 mL
  • Patient with uncontrolled diabetes
  • Radiotherapy within 6 months before screening
  • Experienced Abdominal Radiotherapy
  • Experienced treatment of Gemtuzumab ozogamicin
  • Patient with autoimmune hepatitis or idiopathic thrombocytopenic purpura (ITP)
  • Observation of "attenuated or reversed hepatic venous portal blood flow*" was confirmed by doppler ultrasonography or CT (recommend evaluation in arterial phase, portal-venous phase and equilibrium phase) of the liver * On doppler ultrasonography of right and left branch of portal vein, blood flow is measured as about 0 mL/min or between plus and minus, which indicate obvious blood flow obstruction

Trial locations and contacts

43 sites in 7 countries.

43 sites in 7 countries

Japan16 sites

  • Aichi Cancer Center

    Aichi

  • Chiba Cancer Center

    Chiba

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka

  • Hokkaido University Hospital

    Hokkaido

  • National Hospital Organization Osaka National Hospital

    Osaka

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka

  • Saitama Cancer Center

    Saitama

  • National Hospital Organization Shikoku Cancer Center

    Shikokuchūō

  • Shizuoka Cancer Center

    Shizuoka

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo

  • Kyorin university Hospital

    Tokyo

  • National Cancer Center Hospital East

    Tokyo

  • National Cancer Center Hospital

    Tokyo

  • The Cancer Institute Hospital of JFCR

    Tokyo

  • The University of Tokyo Hospital

    Tokyo

  • Kanagawa Cancer Center

    Yokohama

Other trials in Japan

Taiwan16 sites

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City, 61363

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

  • Chang Gung Memorial Hospital, Kaohsiung Branch

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 40750

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital

    Tainan, 710

  • Mackay Memorial Hospital

    Taipei, 104

  • National Taiwan University Hospital

    Taipei, 106

  • Taipei Medical University Hospital

    Taipei, 110

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 114

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

    Taipei, 235

  • Chang Gung Memorial Hospital, Linkou Branch

    Taipei, 333

  • Chi Mei Medical Center

    Yongkang District, 710

Other trials in Taiwan

South Korea5 sites

  • Ajou University Hospital (AUH)

    Gyeonggi-do, 443-380

  • Samsung Medical Center (SMC)

    Seoul, 135-710

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

    Seoul, 137-701

  • Korea University Guro Hospital (KUGH)

    Seoul, 152-703

  • Yonsei University Health System, Severance Hospital

    Seoul, 50-1

Other trials in South Korea

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Malaysia2 sites

  • Hospital Sultan Ismail

    Johor Bahru

  • Hospital Kuala Lumpur

    Kuala Lumpur

Other trials in Malaysia

Philippines1 site

  • Makati Medical Center

    Makati, 1229

Other trials in Philippines

Singapore1 site

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

About this study

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

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.

Read the 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

Being tested
NC-6004, Gemcitabine
Keywords
Pancreatic cancer, Platinum, Micelle
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NC-6004Drug

    Also called Micelplatin

    Study group (3 week/cycle):

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

  • GemcitabineDrug

    Also called Gemzar

    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

Study groups in NCT02043288
Study groupRoleWhat they receive
NC-6004 and Gemcitabine combinationExperimentalNC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively
Receives: Drug: NC-6004; Drug: Gemcitabine
Gemcitabine monotherapyActive comparatorGemcitabine 1000mg/m2 i.v. on Day 1 ,8 and 15
Receives: Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3.5 years

Secondary outcomes (5)

  1. Progression free survival (PFS)

    Progression free survival is defined as the time from the treatment initiation until progression or death, and censored at the last follow up time.

    Measured: 3.5 years

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

    • 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.

    Measured: 3.5 years

  3. Duration of response

    • 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.

    Measured: 3.5 years

  4. CA19-9

    CA19-9 values and changes from baseline will be summarized.

    Measured: 3.5 years

  5. Quality of life (QoL) using EORTC QLQ-C30

    Quality of life (QoL) values and changes from baseline will be summarized.

    Measured: 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02043288
Sponsor's protocol ID
NC-6004-005
Status last verified
Apr 2020
First submitted
14 Jan 2014
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NC-6004 and Gemcitabine in people with Pancreatic Neoplasms, run by Orient Europharma Co., Ltd. at 43 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Japan, Taiwan, South Korea, Hong Kong, Malaysia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02043288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.

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