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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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Providence Cancer Center Oncology and Hematology Care Clinic-Eastside PortlandSouthfield, Michigan  48075
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