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A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

Thank you

Trial Information

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and
Safety of GS-6624 Combined with Gemcitabine as First Line Treatment for Metastatic
Pancreatic Adenocarcinoma

Inclusion Criteria:

- Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior
to the completion of screening.

- The presence of measurable metastatic pancreatic cancer documented by contrast
enhanced CT (or MRI) scan in addition to 1 of the following:

1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR

2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma
consistent with pancreatic origin in conjunction with either:

1. The presence of a mass in the pancreas OR

2. A history of resected pancreatic carcinoma

- Measurable disease per RECIST (ver. 1.1)

- ECOG Performance Status of 0 or 1.

- Adequate hepatic, hematologic and renal functions.

Exclusion Criteria:

- A history or evidence of clinically significant disorder other than metastatic cancer
of the pancreas.

- A diagnosis of pancreatic islet neoplasms.

- Subject has undergone major surgery other than diagnosis surgery within 4 weeks of

- Presence of biliary obstruction requiring external drainage

- Brain metastases.

- Unstable cardiovascular function within the last 6 months of screening

- Clinically active liver disease, including active viral hepatitis (HBV or HCV) or

- Known HIV infection.

- Uncontrolled hypertension at Screening

- History or presence of any form of cancer, other than pancreatic cancer, within the 3
years prior to enrollment

- Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular
targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable
locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy
given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced
pancreatic cancer are allowed.

- Uncontrolled systemic fungal, bacterial or viral infection

- Participation in an investigational drug or device trial with therapeutic intent
within 30 days prior to study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Safety Issue:


Principal Investigator

Mike Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

September 2013

Related Keywords:

  • Pancreatic Cancer
  • GSI
  • Gilead
  • Gilead Sciences
  • Pancreatic Cancer
  • PC
  • Gemcitabine
  • Phase 2
  • Phase II
  • GS-6624
  • Oncology
  • Monoclonal Antibody
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



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Sharp Health Care San Diego, California  92123
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Central Hematology Oncology Medical Group, Inc. Alhambra, California  91801
Coastal Bend Cancer Center Corpus Christi, Texas  78404
Beth Israel Comprehensive Cancer Center New York, New York  
Charleston Hematology Oncology Associates, PA Charleston, South Carolina  29403
Virginia Cancer Specialists, PC Fairfax, Virginia  22031
Montana Cancer Institute Foundation c/o Montana Cancer Specialists Missoula, Montana  59802
Hematology Oncology Associates, PC Stamford, Connecticut  06902
Hematology and Oncology Associates at BridgePoint Tupelo, Mississippi  38801
Emerywood Hematology and Oncology High Point, North Carolina  27262
UCLA Community Oncology Practice Los Angeles, California  
Saint Mary's Regional Cancer Center Grand Junction, Colorado  
Anne Arundel Medical Center, Annapolis Oncology Center Annapolis, Maryland  
Saint Joseph Oncology, Inc. Saint Joseph, Missouri  
Duke University Medical Center, Comprehensive Cancer Center Durham, North Carolina  
Center for Cancer and Blood Disorders, PC Fort Worth, Texas  
California Cancer Associates for Research and Excellence (CCARE) Fresno, California  93720
San Jose Medical Group San Jose, California  95116
Oncology Hematology Care, Inc. Crestview Hills, Kentucky  41017
Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland Southfield, Michigan  48075
PinnacleHealth Harrisburg, Pennsylvania  17109
Abington Hematology Oncology Associates, Inc. Willow Grove, Pennsylvania  19090
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