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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.

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreas Cancer Locally Advanced Pancreatic Cancer Pancreatic Adenocarcinoma Drug: EndoTAG-1 Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: EndoTAG-1
twice weekly

Drug: Gemcitabine
once weekly

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.
Drug: Gemcitabine
once weekly




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03126435


Contacts
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Contact: Fern Lim +886227603688 ext 2165 fernlim@syncorebio.com

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Sponsors and Collaborators
SynCore Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Li-Tzong Chen, M.D., Ph.D. National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C

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Responsible Party: SynCore Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03126435     History of Changes
Other Study ID Numbers: CT4006
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SynCore Biotechnology Co., Ltd.:
FOLFIRINOX
5-Fluorouracil
folinic acid
irinotecan
oxaliplatin
Gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Pancrelipase
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
Gastrointestinal Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators