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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
N/A
Open (Enrolling)
Both
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
randomization

- 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
cirrhosis

- 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:

Interventional

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:

Yes

Principal Investigator

Mike Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-324-0101

NCT ID:

NCT01472198

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

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
University of South Alabama Mitchell Cancer InstituteMobile, Alabama  36604
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Florida Cancer SpecialistsFort Myers, Florida  33901
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Georgia Cancer Specialists, P.C.East Point, Georgia  30344
Pacific Shores Medical GroupLong Beach, California  90813
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Saint Luke's-Roosevelt Hospital CenterNew York, New York  10019
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Northwestern UniversityChicago, Illinois  60611
Oncology Hematology Care, Inc.Cincinnati, Ohio  45219
Virginia Cancer InstituteRichmond, Virginia  23230
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Sharp Health CareSan Diego, California  92123
Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama  35235
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Central Hematology Oncology Medical Group, Inc.Alhambra, California  91801
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
Beth Israel Comprehensive Cancer CenterNew York, New York  
Charleston Hematology Oncology Associates, PACharleston, South Carolina  29403
Virginia Cancer Specialists, PCFairfax, Virginia  22031
Montana Cancer Institute Foundation c/o Montana Cancer SpecialistsMissoula, Montana  59802
Hematology Oncology Associates, PCStamford, Connecticut  06902
Hematology and Oncology Associates at BridgePointTupelo, Mississippi  38801
Emerywood Hematology and OncologyHigh Point, North Carolina  27262
UCLA Community Oncology PracticeLos Angeles, California  
Saint Mary's Regional Cancer CenterGrand Junction, Colorado  
Anne Arundel Medical Center, Annapolis Oncology CenterAnnapolis, Maryland  
Saint Joseph Oncology, Inc.Saint Joseph, Missouri  
Duke University Medical Center, Comprehensive Cancer CenterDurham, North Carolina  
Center for Cancer and Blood Disorders, PCFort Worth, Texas  
California Cancer Associates for Research and Excellence (CCARE)Fresno, California  93720
San Jose Medical GroupSan Jose, California  95116
Oncology Hematology Care, Inc.Crestview Hills, Kentucky  41017
Providence Cancer Center Oncology and Hematology Care Clinic-Eastside PortlandSouthfield, Michigan  48075
PinnacleHealthHarrisburg, Pennsylvania  17109
Abington Hematology Oncology Associates, Inc.Willow Grove, Pennsylvania  19090
San Antonio Military Medical CenterFort Sam Houston, Texas  78234