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

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

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

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

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