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Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma


Inclusion Criteria:



- Subjects must be 18 years of age or older

- Not previously treated with chemotherapy for Pancreatic Cancer

- ECOG performance status of 0 or 1

- Life expectancy > 3 months

- Documentation of all sites of pancreatic disease within 28 days prior to
randomization

- Adequate hematological, renal, and hepatic function

- Not pregnant or nursing

- Fertile subjects must practice a medically approved method of contraception

Exclusion Criteria:

- Prior history of other malignant tumors

- Participation in another investigational study within 4 weeks prior to treatment
start

- Major surgery within 14 days prior to treatment start

- Radiation treatment within 28 days prior to treatment start

- Uncontrolled cardiac atrial or ventricular arrhythmias

- Gastrointestinal tract disease such resulting in an inability to take oral medication

- Known to be seropositive for HIV, HBV, or HCV

- Uncontrolled cancer pain

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: Health Services Research

Outcome Measure:

Overall Survival

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Manuel Hidalgo, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centro Integral de Oncologia

Authority:

United States: Food and Drug Administration

Study ID:

SCI-RP-Pan-P2-001

NCT ID:

NCT00550004

Start Date:

September 2007

Completion Date:

October 2009

Related Keywords:

  • Pancreatic Cancer
  • Unresectable
  • locally advanced
  • metastatic pancreatic adenocarcinoma
  • Stage III
  • Stage IV
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of WashingtonSeattle, Washington  98195
Cancer Care NorthwestSpokane, Washington  99202
Lakeland Regional Cancer CenterLakeland, Florida  33805
Providence Portland Medical CenterPortland, Oregon  97213-3635
Mid Dakota ClinicBismarck, North Dakota  58501
Gabrail Cancer CenterCanton, Ohio  44718
Utah Cancer SpecialistsSalt Lake City, Utah  84106
University of California at San FranciscoSan Francisco, California  94115
South Texas Oncology and Hematology, PASan Antonio, Texas  78229
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
St. Luke's Cancer CenterBethlehem, Pennsylvania  18015
University of Arizona Medical Center, Arizona Cancer CenterTucson, Arizona  85724
Tower Research Foundation at Tower OncologyBeverly Hills, California  90211
Integrated Community Oncology Network, LLCJacksonville, Florida  32256
Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer CenterMilwaukee, Wisconsin  53226