NCT01431794 - Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 27, 2011

Primary Completion Date

November 5, 2018

Study Completion Date

November 5, 2018

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

LDE225-600mg

"Phase I: oral LDE225 (Sonidegib), 600mg daily.~Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days."

DRUG

Gemcitabine

Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.

DRUG

nab-paclitaxel

Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.

DRUG

LDE225-400mg

Phase I: oral LDE225 (Sonidegib), 400mg daily.

DRUG

LDE225-800mg

Phase I: oral LDE225 (Sonidegib), 800mg daily.

Trial Locations (1)

21205

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore