MedTrace Logo

A Study of CPI-613 With Gemcitabine and Nab-paclitaxel for Patients With Advanced or Metastatic Pancreatic Cancer

NCT03435289 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-19

No results posted yet for this study

Summary

This is a single arm, open-label study of CPI-613 in combination with gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer never treated with systemic chemotherapy.

Conditions

Interventions

DRUG

CPI 613 in Combination With Gemcitabine and Nab-paclitaxel

Day 1,15 CPI-613: IV infusion at a rate of 4 mL/min via a central venous catheter starting at 500 mg/m2 (with concurrent D5W infusing at a rate of 125-150 cc/hr). The CPI dose will be determined based on cohort. Day 2,16 Neulasta as clinically indicated Nab- paclitaxel 125mg/m2 iv over 30 min followed by Gemcitabine 1000mg/m2 iv over 30 min

Sponsors & Collaborators

  • Cornerstone Pharmaceuticals

    collaborator INDUSTRY

  • Atlantic Health System

    lead OTHER

Principal Investigators

  • Angela T Alistar, MD · Morristown Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2018-11-30
Completion
2019-01-31
FDA Drug
Yes

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 NCT03435289 on ClinicalTrials.gov