search
Back to results

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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GV1001
Gemcitabine
Capecitabine
Sponsored by
Samsung Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring GV1001

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chungbuk National University HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting
  • National Cancer CenterRecruiting
  • Jeju National University HospitalRecruiting
  • Chonbuk National University HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Daegu Catholic University Medical CenterRecruiting
  • Konyang University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Gangnam Severance HospitalRecruiting
  • Hanyang University Seoul HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GV1001 + gemcitabine/capecitabine

gemcitabine/capecitabine

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time to tumor progression (TTP)
Objective response rate (ORR)
Objective response rate assesses by CT scan (RECIST and irRC criteria).
Clinical benefit response (CBR)
Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL)
Quality of Life using EORTC QLQ-C30
Quality of Life using EQ-5D-3L
Change in CA19-9 (Serum cancer antigen) over time
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.
Toxicity according to the NCI CTCAE v4.03

Full Information

First Posted
August 31, 2015
Last Updated
November 20, 2016
Sponsor
Samsung Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02854072
Brief Title
A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.
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: Gemcitabine and Capecitabine GV1001+ Gemcitabine and Capecitabine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
GV1001

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GV1001 + gemcitabine/capecitabine
Arm Type
Experimental
Arm Title
gemcitabine/capecitabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GV1001
Other Intervention Name(s)
Tertomotide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000 mg/m^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
Time to tumor progression (TTP)
Time Frame
one year
Title
Objective response rate (ORR)
Description
Objective response rate assesses by CT scan (RECIST and irRC criteria).
Time Frame
one year
Title
Clinical benefit response (CBR)
Time Frame
one year
Title
Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL)
Time Frame
one year
Title
Quality of Life using EORTC QLQ-C30
Time Frame
up to one year
Title
Quality of Life using EQ-5D-3L
Time Frame
up to one year
Title
Change in CA19-9 (Serum cancer antigen) over time
Description
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.
Time Frame
one year
Title
Toxicity according to the NCI CTCAE v4.03
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 19 years Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas. Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer. 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. Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines. ECOG performance status 0, 1 or 2. 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 Life expectancy ≥ 90 days Fully informed written consent given. Exclusion Criteria: Brain metastasis or meningeal carcinomatosis. Clinically significant serious disease or organ system disease not currently controlled on present therapy. 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. Radiotherapy within the last 8 weeks prior to start of study treatment. 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. 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. Administration of medicines from other clinical trials within 8 weeks from registration. Pregnancy or breast feeding. Uncontrolled angina pectoris. Known malabsorption syndromes. Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom. Investigator's judgment against participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Park
Email
hpark@kaelgemvax.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon Jin Lee
Email
yjlee@kaelgemvax.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Si Young Song, M.D.
Organizational Affiliation
Severance Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yong-Tae Kim, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ho Soon Choi, M.D.
Organizational Affiliation
Hanyang University Seoul Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ho Gak Kim, M.D.
Organizational Affiliation
Daegu Catholic University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Sik Lee, M.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Woo Choi, M.D.
Organizational Affiliation
Konyang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gwang Ha Kim, M.D.
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwang Hyuck Lee, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Hee Cho, M.D.
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joung-Ho Han, M.D.
Organizational Affiliation
Chungbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seung Ok Lee, M.D.
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang-Hwan Park, M.D.
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eun Kwang Choi, M.D.
Organizational Affiliation
Jeju National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyong Joo Lee, M.D.
Organizational Affiliation
Wonju Severance Christian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Yong Cho, M.D.
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo Jin Lee, M.D.
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joung-Ho Han, M.D.
Facility Name
Wonju Severance Christian Hospital
City
Wonju-si
State/Province
Gangwon-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyong Joo Lee, M.D.
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Jin Lee, M.D.
Facility Name
Jeju National University Hospital
City
Jeju-si
State/Province
Jeju-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Kwang Choi, M.D.
Facility Name
Chonbuk National University Hospital
City
Jeonju-si
State/Province
Jeollabuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Ok Lee, M.D.
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwang Ha Kim, M.D.
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Gak Kim, M.D.
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Woo Choi, M.D.
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Hwan Park, M.D.
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hee Cho, M.D.
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Yong Cho, M.D.
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Soon Choi, M.D.
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Sik Lee, M.D.
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwang Hyuck Lee, M.D.
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Tae Kim, M.D.
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si Young Song, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs