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Alpha-interferon

Phase 2

Pancreatic Cancer | Monoclonal antibody | Oncology |Sanofi|Last Updated: May 26, 2010

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Alpha-interferon · 1 trial · 1 indication

Phase 2 1
NCT00761241Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RTPancreatic Cancer
COMPLETED40 Analytics
PHASE2COMPLETED
Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Two year overall survival
two years

Secondary Endpoints

median disease free survival initial response rate to gemcitabine/docetaxel (tumor marker and radiographic) toxicity of overall regimen time to disease progression percentage of patients able to complete protocol to entirety
two years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Gemcitabine, Docetaxel, 5FU, OxaliplatinDRUGGemcitabine: 1000 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8cycles Docetaxel: 40 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8 cycles Gemcitabine/docetaxel will be repeated (based upon initial response) Oxaliplatin: 40 mg/m2 IV on day 1 of each week of radiation 5-FU: 175 mg/m2 continuous infusion on days 1-18 and 29-46 of radiation
Alpha-interferonBIOLOGICALAlpha-interferon: injected subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 29, 31, 33, 36, 38, 40, 43 and 46 during radiation therapy
Abdominal/pelvic radiation therapyRADIATION3-D conformal technique. The dose per fraction will be 180cGy, with a total dose of 5040 cGy in 28 fractions. Radiation therapy will be delivered on days 1-18 and days 29-46
PancreaticoduodenectomyPROCEDURESurgery performed if subject is considered candidate by protocol definition.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Biopsy proven adenocarcinoma of the pancreas * Tumor must be radiographically bidimensional by abdominal/pelvic CT * Cancer must be locally advanced and not considered immediately treated by standard surgical procedure * No prior therapy for pancreas cancer Exclusion Criteria...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 177 trials