A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients
NCT ID: NCT02854072
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
148 participants
INTERVENTIONAL
2015-11-30
2018-05-31
Brief Summary
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Detailed Description
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Patients will be randomized equally between the two arms:
1. Gemcitabine and Capecitabine
2. GV1001+ Gemcitabine and Capecitabine
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GV1001 + gemcitabine/capecitabine
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.
Gemcitabine
Gemcitabine 1000 mg/m\^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.
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.
gemcitabine/capecitabine
Gemcitabine
Gemcitabine 1000 mg/m\^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.
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.
Interventions
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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.
Gemcitabine
Gemcitabine 1000 mg/m\^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Samsung Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Si Young Song, M.D.
Role: STUDY_CHAIR
Severance Hospital
Yong-Tae Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Ho Soon Choi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hanyang University Seoul Hospital
Ho Gak Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Daegu Catholic University Medical Center
Hong Sik Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Young Woo Choi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Konyang University Hospital
Gwang Ha Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Kwang Hyuck Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Jae Hee Cho, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gachon University Gil Medical Center
Joung-Ho Han, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chungbuk National University Hospital
Seung Ok Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Chang-Hwan Park, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Eun Kwang Choi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Jeju National University Hospital
Kyong Joo Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wonju Severance Christian Hospital
Jae Yong Cho, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Woo Jin Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center
Locations
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Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Jeju National University Hospital
Jeju City, Jeju-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Pusan National University Hospital
Busan, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Kyong Joo Lee, M.D.
Role: primary
Woo Jin Lee, M.D.
Role: primary
Eun Kwang Choi, M.D.
Role: primary
Seung Ok Lee, M.D.
Role: primary
Joung-Ho Han, M.D.
Role: primary
Gwang Ha Kim, M.D.
Role: primary
Ho Gak Kim, M.D.
Role: primary
Young Woo Choi, M.D.
Role: primary
Chang-Hwan Park, M.D.
Role: primary
Jae Hee Cho, M.D.
Role: primary
Jae Yong Cho, M.D.
Role: primary
Ho Soon Choi, M.D.
Role: primary
Hong Sik Lee, M.D.
Role: primary
Kwang Hyuck Lee, M.D.
Role: primary
Yong-Tae Kim, M.D.
Role: primary
Si Young Song, M.D.
Role: primary
References
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Jo JH, Kim YT, Choi HS, Kim HG, Lee HS, Choi YW, Kim DU, Lee KH, Kim EJ, Han JH, Lee SO, Park CH, Choi EK, Kim JW, Cho JY, Lee WJ, Moon HR, Park MS, Kim S, Song SY. Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial. Br J Cancer. 2024 Jan;130(1):43-52. doi: 10.1038/s41416-023-02474-w. Epub 2023 Oct 30.
Other Identifiers
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KG 4/2015
Identifier Type: -
Identifier Source: org_study_id