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EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

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ClinicalTrials.gov Identifier: NCT03126435
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
SynCore Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 19, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE June 11, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
Overall survival [ Time Frame: 1 year ]
Overall survival time is defined as time from randomization to death from any cause or last day known to be alive
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03126435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Progression Free Survival [ Time Frame: 6 months ]
    Progression Free Survival time is defined as the time from randomization to either first observation of progressive disease or occurrence of death
  • Percentage of subjects with Objective Response [ Time Frame: 1 year ]
    Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.
  • Duration of Response [ Time Frame: 1 year ]
    Duration of Response is defined as the time from the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause.
  • Percentage of subjects with disease control according to RECIST v.1.1 [ Time Frame: 1 year ]
    Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1
  • Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score [ Time Frame: 1 year ]
    EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
  • Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score [ Time Frame: 1 year ]
    QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
  • Serum Carcinoma Antigen 19-9 (CA 19-9) response rate [ Time Frame: 1 year ]
    Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment
Official Title  ICMJE A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment
Brief Summary The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Pancreas Cancer
  • Locally Advanced Pancreatic Cancer
  • Pancreatic Adenocarcinoma
Intervention  ICMJE
  • Drug: EndoTAG-1
    twice weekly
  • Drug: Gemcitabine
    once weekly
Study Arms  ICMJE
  • Experimental: EndoTAG-1 and Gemcitabine
    EndoTAG-1 22 mg/m2 twice weekly plus gemcitabine 1000mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
    Interventions:
    • Drug: EndoTAG-1
    • Drug: Gemcitabine
  • Gemcitabine
    Gemcitabine 1000mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
    Intervention: Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
218
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2017)
214
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Written informed consent
  3. Histologically or cytologically confirmed adenocarcinoma of the pancreas
  4. Metastatic or locally advanced disease that is considered unresectable
  5. Measurable / assessable disease according to RECIST v.1.1
  6. Documented disease progression on first line FOLFIRINOX
  7. Negative pregnancy test
  8. Both male and female patients and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential during the course of the study and for 90 days after last treatment (excluding women who are not of childbearing potential and men who have been sterilized).
  9. ECOG performance status 0 or 1

Exclusion Criteria:

  1. Cardiovascular disease, New York Heart Association (NYHA) III or IV
  2. History of severe supraventricular or ventricular arrhythmia
  3. History of coagulation or bleeding disorder
  4. History of acute myocardial infarction within 6 months before randomization
  5. History of congestive heart failure
  6. Acute or chronic inflammation (autoimmune or infectious)
  7. Significant active/unstable non-malignant disease likely to interfere with study assessments
  8. Laboratory tests (hematology, chemistry) outside specified limits:

    1. WBC ≤ 3 x 10³/mm³
    2. ANC ≤ 1.5 x 10³/mm³
    3. Platelets ≤ 100.000/mm³
    4. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
    5. aPTT > 1.5 x ULN
    6. Serum creatinine > 2.0 mg/dl (> 176.8 μmol/l)
    7. AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
    8. Alkaline phosphatase > 2.5 x ULN
    9. Total bilirubin > 2 x ULN
    10. Albumin < 2.5 g/dL
  9. Clinically significant ascites
  10. Any anti-tumor treatment (except FOLFIRINOX as the first-line therapy) for pancreatic adenocarcinoma before enrollment. Note: Patients who have undergone surgical interventions for pancreatic adenocarcinoma will be eligible.
  11. Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
  12. Major surgery < 4 weeks prior to enrollment
  13. Pregnant or nursing
  14. Investigational medicinal product < 4 weeks of enrollment
  15. Documented HIV history
  16. Active hepatitis B infection requiring acute therapy Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria.
  17. Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations
  18. History of malignancy other than pancreatic cancer < 3 years prior to enrollment, except nonmelanoma skin cancer or carcinoma in situ of the cervix treated locally
  19. Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fern Lim +886227603688 ext 2165 fernlim@syncorebio.com
Listed Location Countries  ICMJE France,   Hungary,   Israel,   Korea, Republic of,   Romania,   Russian Federation,   Taiwan,   United States
Removed Location Countries Czechia,   Spain
 
Administrative Information
NCT Number  ICMJE NCT03126435
Other Study ID Numbers  ICMJE CT4006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SynCore Biotechnology Co., Ltd.
Study Sponsor  ICMJE SynCore Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li-Tzong Chen, M.D., Ph.D. National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C
PRS Account SynCore Biotechnology Co., Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP