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Anti-metabolites

Sorafenib for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Andrew Poklepovic, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a combination of two drugs, sorafenib and vorinostat, with gemcitabine and radiation therapy as neoadjuvant treatment of pancreatic cancer following chemotherapy. The recommended phase II dose and schedule of sorafenib and vorinostat is the same as or less than the maximum tolerated dose and schedule.

Eligible Conditions
  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase 2 dose and schedule
Secondary outcome measures
Number of participants with adverse events using National Cancer Institute CTCAE v4.0
Overall Survival
Progression-free survival (PFS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, chemoradiation)Experimental Treatment7 Interventions
Participants receive gemcitabine IV infusion over 30 minutes (200 mg/m2 weekly) x 6, concurrent administration of oral sorafenib and oral vorinostat (both per dose-escalation schema), and concurrent RT( 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy) administered at 1.8-Gy fractions to a total dose of 50.4 Gy over 5 ½ weeks (28 daily fractions).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
FDA approved
Gemcitabine
FDA approved
Vorinostat
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,885,022 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,143 Total Patients Enrolled
Andrew Poklepovic, MDPrincipal InvestigatorMassey Cancer Center
4 Previous Clinical Trials
222 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Apr 2025