Phase 2
N=202
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01395017 ↗Enrolled (actual)
202
Serious AEs
50.7%
Results posted
Mar 2015
Primary outcome: Primary: Overall Survival — 375; 393 Days — p=0.3864
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dasatinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
375; 393 | 0.3864 |
| SECONDARY Progression Free Survival (PFS) |
167; 166 | 0.6761 |
Summary
The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas.
- Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or 1.
- Adequate organ function.
Exclusion Criteria
- Evidence of metastatic disease.
- Previous radiotherapy or chemoradiotherapy.
- History of or current pleural effusion.
- History of significant cardiovascular disease.
- Clinically significant bleeding disorder or coagulopathy.
- Concomitant medication with strong CYP 3A4 inhibitor.
Data sourced from ClinicalTrials.gov (NCT01395017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.