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

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

Detailed Description
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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

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: GV1001
* Drug: Gemcitabine
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GV1001 + gemcitabine/capecitabine<br> | Drug: GV1001<br>* 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.<br>* Other names: Tertomotide;Drug: Gemcitabine<br>* Gemcitabine 1000 mg/m^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.<br>Drug: Capecitabine<br>* 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.<br>|
| Active Comparator: gemcitabine/capecitabine<br> | Drug: Gemcitabine<br>* Gemcitabine 1000 mg/m^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.<br>Drug: Capecitabine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor progression (TTP) |  | one year | 
| Objective response rate (ORR) | Objective response rate assesses by CT scan (RECIST and irRC criteria). | one year | 
| Clinical benefit response (CBR) |  | one year | 
| Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL) |  | one year | 
| Quality of Life using EORTC QLQ-C30 |  | up to one year | 
| Quality of Life using EQ-5D-3L |  | up to one year | 
| 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. | one year | 
| Toxicity according to the NCI CTCAE v4.03 |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GV1001