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
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer
Both
Pancreatic Cancer
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 Medicine | Houston, Texas 77030 |
| University of Washington | Seattle, Washington 98195 |
| Cancer Care Northwest | Spokane, Washington 99202 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| Mid Dakota Clinic | Bismarck, North Dakota 58501 |
| Gabrail Cancer Center | Canton, Ohio 44718 |
| Utah Cancer Specialists | Salt Lake City, Utah 84106 |
| University of California at San Francisco | San Francisco, California 94115 |
| South Texas Oncology and Hematology, PA | San Antonio, Texas 78229 |
| Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
| St. Luke's Cancer Center | Bethlehem, Pennsylvania 18015 |
| University of Arizona Medical Center, Arizona Cancer Center | Tucson, Arizona 85724 |
| Tower Research Foundation at Tower Oncology | Beverly Hills, California 90211 |
| Integrated Community Oncology Network, LLC | Jacksonville, Florida 32256 |
| Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center | Milwaukee, Wisconsin 53226 |
