Trial intelligence / Profile preview

Ivaltinostat with Gemcitabine and Erlotinib in Pancreatic Cancer

NCT02737228Phase 2

Key facts

Status: Unknown
Start: Mar 2016
Primary completion: Aug 2019
Countries: 1
Sponsor: Crystal Genomics
Modality: Small Molecules

Drugs: ivaltinostat
Conditions: pancreatic adenocarcinoma (PDAC)

Overview

Phase 2, open-label, single-arm trial of ivaltinostat in pancreatic adenocarcinoma (PDAC), sponsored by Crystal Genomics. Primary endpoint: Overall Response Rate. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

CG200745 PPA + Gemcitabine + Erlotinib
Combination therapy with dose escalation of CG200745 PPA in Phase I and recommended dose in Phase II.

Who it enrols

Adult patients (20-75 years) with locally advanced or metastatic pancreatic adenocarcinoma, ECOG 0-2, and adequate organ function. Patients must not have received prior chemotherapy, radiation, or biologics.

Endpoints

Primary

Overall Response Rateup to 6 cycles

Secondary

Disease Control Rateup to 6 cycles
Area Under the Curveup to 1440 mins after administration
Maximum Plasma Concentrationup to 1440 mins after administration
Adverse Eventsup to 6 cycles
Clinical laboratory testsup to 6 cycles

Beyond the preview

Go deeper on NCT02737228.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT02737228.