Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer (LAPC)

Otsuka

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: dasatinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395017

287-11-201

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

202 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).

Treatment:

Drug: dasatinib

Group 2

Placebo Comparator group

Description:

The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).

Treatment:

Drug: Placebo