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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT01360853

Public ClinicalTrials.gov record NCT01360853. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 2, 2026, 9:00 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined With Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01360853
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Traws Pharma, Inc.
Industry
Enrollment
160 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2011 (Type not available)
Primary completion
Jun 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Aug 4, 2016

2011 – 2015

United States locations

U.S. sites
30
U.S. states
18
U.S. cities
30
Facility City State ZIP Site status
UCSD Moores Cancer Center La Jolla California 92037 —
Desert Comprehensive Cancer Center Palm Springs California 92262 —
Pacific Cancer Care Salinas California 93901 —
Premiere Oncology Santa Monica California 90404 —
University of Colorado Cancer Center Aurora Colorado 80045 —
Kaiser Permanente Colorado Denver Colorado 80205 —
Poudre Valley Cancer Center of the Rockies Fort Collins Colorado 80528 —
Yale Cancer Center New Haven Connecticut 06519 —
Mount Sinai Comprehensive Cancer Center Miami Beach Florida 33140 —
University of Hawaii Cancer Center Honolulu Hawaii 96813 —
University of Kansas Cancer Center Westwood Kansas 66205 —
UMASS Medical School Worcester Massachusetts 01655 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Billings Clinic Cancer Center Billings Montana 59101 —
Roswell Park Cancer Institute Buffalo New York 14263 —
New York University Langone Medical Center New York New York 10016 —
University of Rochester Medical Center Rochester New York 14642 —
University of North Carolina Lineberger Comprehensive Cancer Center Chapel Hill North Carolina 27599 —
Levine Cancer Institute Charlotte North Carolina 28204 —
Cone Health Cancer Center Greensboro North Carolina 27403 —
Hendersonville Hematology and Oncology at Pardee Hendersonville North Carolina 28971 —
Rex Cancer Center UNC Healthcare Raleigh North Carolina 27607 —
St. Alexis Medical Center-Mid Dakota Clinic PC Bismarck North Dakota 58501 —
University of Cincinnati Cancer Center Cincinnati Ohio 45219 —
Kaiser Permanente NW Portland Oregon 97227 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
Medical University of South Carolina - Hollings Cancer Center Charleston South Carolina 29425 —
McLeod Regional Medical Center Florence South Carolina 29506 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232 —
Seattle Cancer Care Alliance Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01360853, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 4, 2016 · Synced Nov 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01360853 live on ClinicalTrials.gov.

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