Clinical trial NCT02854072: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: GV1001
Lead sponsor: Samsung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-03
Enrollment: 148
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Gemcitabine and Capecitabine
2. GV1001+ Gemcitabine and Capecitabine

Eligibility 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

Primary outcomes:
measure: Overall Survival
timeFrame: one year
Secondary outcomes:
measure: Time to tumor progression (TTP)
timeFrame: one year
measure: Objective response rate (ORR)
timeFrame: one year
measure: Clinical benefit response (CBR)
timeFrame: one year
measure: Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL)
timeFrame: one year
measure: Quality of Life using EORTC QLQ-C30
timeFrame: up to one year
measure: Quality of Life using EQ-5D-3L
timeFrame: up to one year
measure: Change in CA19-9 (Serum cancer antigen) over time
timeFrame: one year
measure: Toxicity according to the NCI CTCAE v4.03
timeFrame: one year
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Wonju-si
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Jeju-si
country: Korea, Republic of
facility: Jeju National University Hospital
state: Jeju-do
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Si Young Song, M.D.
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Yong-Tae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University Seoul Hospital
name: Ho Soon Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Ho Gak Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Hong Sik Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konyang University Hospital
name: Young Woo Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Gwang Ha Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Kwang Hyuck Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: Jae Hee Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: Joung-Ho Han, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Seung Ok Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Chang-Hwan Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeju National University Hospital
name: Eun Kwang Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Severance Christian Hospital
name: Kyong Joo Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangnam Severance Hospital
name: Jae Yong Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Center
name: Woo Jin Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: