Clinical trialNCT01360853CompletedPhase 3Interventional

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

SponsorTraws Pharma, Inc.Enrollment160Metastatic Pancreatic Adenocarcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Antonio Jimeno, MD, PhD
Anschutz Cancer Pavilion
Study ChairKOL profile →
clinicaltrials.gov ↗
Lawrence P. Leichman, MD
Academic Oncology Gastrointestinal Cancer Consortium
Study Chair
clinicaltrials.gov ↗
Wells Messersmith, MD
Anschutz Cancer Pavilion
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

46 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Hungary

Semmelweis University Department of Diagnostic Radiology and Oncotherapy
Budapest, Hungary
Semmelweis University, 3rd Department of Internal Medicine
Budapest, Hungary
Hetenyi Geza Hospital 5004, Szolnok, Hungary
Szolnok, Hungary

India

Basavatarakam Indo-American Cancer Hospital
Hyderabad, Andhra Pradesh, India
Regional Cancer Center
Thiruvananthapuram, Kerala, India
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India
Shatabdi Superspeciality Hospital
Nashik, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Lifeline Multispeciality Hospitals
Chennai, Tamil Nadu, India

Russia

State Budget Medical Institution of the Arkhangelsk Region
Arkhangelsk, Russia
Chelyabinsk Regional Clinical Oncology Center
Chelyabinsk, Russia
State Budget Medical Institution Clinical Oncology Center 1
Krasnodar, Russia
Budget Medical Institution of the Omsk Region: Clinical Oncology Center
Omsk, Russia
State Budget Medical Institution: Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
State Medical Institution: Tula Regional Oncology Center
Tula, Russia

Ukraine

Zakarpattia Regional Clinical Oncology Center Department of Chemotherapy
Uzhhorod, Ukraine

United States

Ucsd Moores Cancer Center
La Jolla, California, United States
Desert Comprehensive Cancer Center
Palm Springs, California, United States
Pacific Cancer Care
Salinas, California, United States
Premiere Oncology
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Kaiser Permanente Colorado
Denver, Colorado, United States
Poudre Valley Cancer Center of the Rockies
Fort Collins, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Umass Medical School
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York University Langone Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, United States
Rex Cancer Center Unc Healthcare
Raleigh, North Carolina, United States
St. Alexis Medical Center-Mid Dakota Clinic Pc
Bismarck, North Dakota, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States

6 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

GemcitabineRigosertib Sodium

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2011
Primary completion: 30 Jun 2015
Completion: 31 Dec 2015
Last update posted: 4 Aug 2016
Registered enrollment: 160
Registry id: NCT01360853

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.