MedTrace Logo

Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer

NCT01360853 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2016-08-04

No results posted yet for this study

Summary

The question being asked in this study is: Will patients with advanced pancreatic cancer live significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na than if they are treated with Gemcitabine alone? There are two parts to this study. In the first part of the study, patients with metastatic pancreatic cancer who have received no prior chemotherapy for this disease will be assigned by chance either to the group that will be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group) or, to the group that will be treated with Gemcitabine only (about 50 patients will be in this group). How long patients survive in the 2 groups will be compared. If it looks like there is no difference between the groups, the study will stop. If it looks like patients in the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study will continue into a second part where more patients will be treated in order to confirm and better understand the findings of the first part of the study.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

ON 01910.Na

ON 01910.Na, 1800 mg/m2 via 2 hr CIV infusions administered twice weekly for 3 weeks of a 4 week cycle.

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 weekly for 3 weeks of a 4 week cycle.

DRUG

Gemcitabine

Gemcitabine, 1000 mg/m2 weekly for 3 weeks of a 4 week cycle.

Sponsors & Collaborators

  • Academic GI Cancer Consortium (AGICC)

    collaborator OTHER

  • Traws Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Wells Messersmith, MD · Anschutz Cancer Pavilion

  • Lawrence P. Leichman, MD · Academic Oncology Gastrointestinal Cancer Consortium

  • Antonio Jimeno, MD, PhD · Anschutz Cancer Pavilion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • United States
  • Hungary
  • India
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT01360853 on ClinicalTrials.gov