We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02854072
Recruitment Status : Unknown
Verified July 2016 by Samsung Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Samsung Pharmaceutical Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: GV1001 Drug: Gemcitabine Drug: Capecitabine Phase 3

Detailed Description:

This study is designed as a phase III, prospective, randomized, open-label, multicenter clinical trial comparing GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in treating locally advanced and metastatic pancreatic cancer patients. Patients will be treated until disease progression and will be subject to follow-up until death.

Patients will be randomized equally between the two arms:

  1. Gemcitabine and Capecitabine
  2. GV1001+ Gemcitabine and Capecitabine
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-label, Multicenter, Parallel Design, Phase III Study to Assess the Efficacy and Safety of GV1001 Concurrent With Gemcitabine/Capecitabine Versus Gemcitabine/Capecitabine Alone in Treating Locally Advanced and Metastatic Pancreatic Cancer Patients
Study Start Date : November 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: GV1001 + gemcitabine/capecitabine Drug: GV1001
At week 1, GV1001 will be administered intradermally on day 1, day 3 and day 5. This will be followed by a once weekly schedule for weeks 2, 3, 4 and 6. After that, GV1001 will be administered once monthly until withdrawal from trial treatment due to patient choice, intolerable toxicity or disease progression. GM-CSF will be used as an adjuvant, given 10-15 minutes prior to each administration of GV1001.
Other Name: Tertomotide

Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.

Drug: Capecitabine
Capecitabine 830 mg/m^2 will be orally given in the morning and evening (total dose of 1660 mg/m^2) for 21 days followed by 7 days' rest.
Active Comparator: gemcitabine/capecitabine Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.

Drug: Capecitabine
Capecitabine 830 mg/m^2 will be orally given in the morning and evening (total dose of 1660 mg/m^2) for 21 days followed by 7 days' rest.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Time to tumor progression (TTP) [ Time Frame: one year ]
  2. Objective response rate (ORR) [ Time Frame: one year ]
    Objective response rate assesses by CT scan (RECIST and irRC criteria).

  3. Clinical benefit response (CBR) [ Time Frame: one year ]
  4. Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL) [ Time Frame: one year ]
  5. Quality of Life using EORTC QLQ-C30 [ Time Frame: up to one year ]
  6. Quality of Life using EQ-5D-3L [ Time Frame: up to one year ]
  7. Change in CA19-9 (Serum cancer antigen) over time [ Time Frame: one year ]
    Cancer antigen 19-9 (CA 19-9) is used to help differentiate between cancer of the pancreas and other conditions, as well as to monitor treatment response and recurrence.

  8. Toxicity according to the NCI CTCAE v4.03 [ Time Frame: one year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 19 years
  2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas.
  3. Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer.
  4. Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up to a maximum of 32 days) prior to commencing treatment.
  5. Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines.
  6. ECOG performance status 0, 1 or 2.

  7. Adequate organ function as determined by the following laboratory values:

    • Platelets ≥100 x 10^9 /L
    • WBC ≥ 3 x 10^9 /L
    • ANC ≥1.5 x 10^9 /L
    • Serum total bilirubin ≤ 2.0 mg/dL
    • CCr (Cockcroft & Gault) > 50 mL/min
  8. Life expectancy ≥ 90 days
  9. Fully informed written consent given.

Exclusion Criteria:

  1. Brain metastasis or meningeal carcinomatosis.
  2. Clinically significant serious disease or organ system disease not currently controlled on present therapy.
  3. Previous chemotherapy for locally advanced and metastatic disease. Previously adjuvant chemotherapy for resected pancreatic cancer will be permitted providing chemotherapy was completed more than 12 months previously.
  4. Radiotherapy within the last 8 weeks prior to start of study treatment.
  5. Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer.
  6. Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms.
  7. Administration of medicines from other clinical trials within 8 weeks from registration.
  8. Pregnancy or breast feeding.
  9. Uncontrolled angina pectoris.
  10. Known malabsorption syndromes.
  11. Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency.
  12. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
  13. Investigator's judgment against participation in the study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02854072


Contacts
Layout table for location contacts
Contact: Hanna Park hpark@kaelgemvax.com
Contact: Yoon Jin Lee yjlee@kaelgemvax.com

Locations
Layout table for location information
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Contact: Joung-Ho Han, M.D.         
Wonju Severance Christian Hospital Recruiting
Wonju-si, Gangwon-do, Korea, Republic of
Contact: Kyong Joo Lee, M.D.         
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Woo Jin Lee, M.D.         
Jeju National University Hospital Recruiting
Jeju-si, Jeju-do, Korea, Republic of
Contact: Eun Kwang Choi, M.D.         
Chonbuk National University Hospital Recruiting
Jeonju-si, Jeollabuk-do, Korea, Republic of
Contact: Seung Ok Lee, M.D.         
Pusan National University Hospital Recruiting
Busan, Korea, Republic of
Contact: Gwang Ha Kim, M.D.         
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Ho Gak Kim, M.D.         
Konyang University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Young Woo Choi, M.D.         
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Chang-Hwan Park, M.D.         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Jae Hee Cho, M.D.         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae Yong Cho, M.D.         
Hanyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ho Soon Choi, M.D.         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hong Sik Lee, M.D.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kwang Hyuck Lee, M.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong-Tae Kim, M.D.         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Si Young Song, M.D.         
Sponsors and Collaborators
Samsung Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Study Chair: Si Young Song, M.D. Severance Hospital
Principal Investigator: Yong-Tae Kim, M.D. Seoul National University Hospital
Principal Investigator: Ho Soon Choi, M.D. Hanyang University Seoul Hospital
Principal Investigator: Ho Gak Kim, M.D. Daegu Catholic University Medical Center
Principal Investigator: Hong Sik Lee, M.D. Korea University Anam Hospital
Principal Investigator: Young Woo Choi, M.D. Konyang University Hospital
Principal Investigator: Gwang Ha Kim, M.D. Pusan National University Hospital
Principal Investigator: Kwang Hyuck Lee, M.D. Samsung Medical Center
Principal Investigator: Jae Hee Cho, M.D. Gachon University Gil Medical Center
Principal Investigator: Joung-Ho Han, M.D. Chungbuk National University Hospital
Principal Investigator: Seung Ok Lee, M.D. Chonbuk National University Hospital
Principal Investigator: Chang-Hwan Park, M.D. Chonnam National University Hospital
Principal Investigator: Eun Kwang Choi, M.D. Jeju National University Hospital
Principal Investigator: Kyong Joo Lee, M.D. Wonju Severance Christian Hospital
Principal Investigator: Jae Yong Cho, M.D. Gangnam Severance Hospital
Principal Investigator: Woo Jin Lee, M.D. National Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Samsung Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02854072    
Other Study ID Numbers: KG 4/2015
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Samsung Pharmaceutical Co., Ltd.:
GV1001
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
 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