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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854072
• Other study ID #: KG 4/2015
• Status: Recruiting
• Phase: Phase 3
• First received: August 31, 2015
• Last updated: November 20, 2016
• Start date: November 2015
• Est. completion date: May 2018

Study information

• Verified date: July 2016
• Source: Samsung Pharmaceutical Co., Ltd.
• Contact: Hanna Park
• Email: hpark[@]kaelgemvax.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju-si	Jeju-do
Korea, Republic of	Chonbuk National University Hospital	Jeonju-si	Jeollabuk-do
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju-si	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		one year	No
Secondary	Time to tumor progression (TTP)		one year	No
Secondary	Objective response rate (ORR)	Objective response rate assesses by CT scan (RECIST and irRC criteria).	one year	No
Secondary	Clinical benefit response (CBR)		one year	No
Secondary	Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL)		one year	No
Secondary	Quality of Life using EORTC QLQ-C30		up to one year	No
Secondary	Quality of Life using EQ-5D-3L		up to one year	No
Secondary	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	No
Secondary	Toxicity according to the NCI CTCAE v4.03		one year	No