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Safety and Efficacy Study of PRI-724 Plus Gemcitabine in Subjects With Advanced or Metastatic Pancreatic Adenocarcinoma

NCT01764477 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-17

No results posted yet for this study

Summary

Laboratory studies suggest that the study drug may stop cancer cells from growing by affecting an interaction between proteins in the cells referred to as cAMP-response element-binding protein and ß-catenin.

The purpose of this research study is to determine the highest safe dose of study drug that may be used when it is given together with a chemotherapy drug to patients with cancer of the pancreas.

Conditions

Interventions

DRUG

PRI-724

Gemcitabine: 1000 mg/m2 IV over 30 minutes; once weekly dosing; 3 weeks on with 1 week recovery (4 weeks per cycle) PRI-724: Cohort 1: 320 mg/m2/day; Cohort 2: 640 mg/m2/day; Cohort 3: 905 mg/m2/day; Continuous IV over 24 hours; daily x 7 days; 1 week on with 1 week recovery × 2 (4 weeks per cycle)

Sponsors & Collaborators

  • inVentiv Health Clinical

    collaborator OTHER

  • Prism Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Robert R. McWilliams, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764477 on ClinicalTrials.gov