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

Summary

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

Conditions

• Pancreatic Cancer

Interventions

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.

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.

Sponsors & Collaborators

• Samsung Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Si Young Song, M.D. · Severance Hospital

• Yong-Tae Kim, M.D. · Seoul National University Hospital

• Ho Soon Choi, M.D. · Hanyang University Seoul Hospital

• Ho Gak Kim, M.D. · Daegu Catholic University Medical Center

• Hong Sik Lee, M.D. · Korea University Anam Hospital

• Young Woo Choi, M.D. · Konyang University Hospital

• Gwang Ha Kim, M.D. · Pusan National University Hospital

• Kwang Hyuck Lee, M.D. · Samsung Medical Center

• Jae Hee Cho, M.D. · Gachon University Gil Medical Center

• Joung-Ho Han, M.D. · Chungbuk National University Hospital

• Seung Ok Lee, M.D. · Chonbuk National University Hospital

• Chang-Hwan Park, M.D. · Chonnam National University Hospital

• Eun Kwang Choi, M.D. · Jeju National University Hospital

• Kyong Joo Lee, M.D. · Wonju Severance Christian Hospital

• Jae Yong Cho, M.D. · Gangnam Severance Hospital

• Woo Jin Lee, M.D. · National Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-05-31

Completion

2018-05-31

Countries

• South Korea

Study Locations