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Metastatic Pancreatic AdenocarcinomaPhase 3ONTRACNCT01360853

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

A Phase 3 study testing ON 01910.Na and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, run by Traws Pharma, Inc. at 46 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
ON 01910.Na and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
46 sitesin 5 countries
Study dates
May 2011to Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients at least 18 years old presenting with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas; metastatic disease is defined as disease which has spread beyond the peri-pancreatic lymph nodes.
  • Patients must have received no prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy.
  • Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be ≥15 mm in the short axis.
  • ECOG Performance Status of 0, 1, or 2.
  • Patients must have adequate renal function and serum creatinine ≤2.0 mg/dL.
  • Patients must have adequate liver function as defined by total bilirubin ≤2.0 mg/dL and transaminase levels no higher than 3.0 times the institution's upper limit of normal (ULN). Patients with hepatic metastases may have transaminase levels of up to 5.0 times the ULN.
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  • All patients must have a serum albumin ≥3.0 g/dL.
  • Patients must have adequate bone marrow (BM) function as defined by a granulocyte count ≥1,500/mm3, a platelet count ≥100,000/mm3, and hemoglobin >9 g/dL.
  • Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] breast disease).
  • Adequate contraceptive regimen (including prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study for female patients of reproductive potential or female partners of male patients.
  • Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin (bHCG) pregnancy test at Screening.
  • Willing to adhere to the prohibitions and restrictions specified in this protocol.
  • Patient must have signed an informed consent document.

Who cannot join

  • Patients with unresectable locally advanced disease without evidence of disease elsewhere.
  • Life expectancy of less than 12 weeks.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or seizure disorder.
  • Active infection not adequately responding to appropriate therapy.
  • Symptomatic or clinically evident ascites.
  • Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia.
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  • Female patients who are pregnant or lactating.
  • Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol.
  • Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
  • Evidence of brain metastases.
  • Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of radiotherapy, or immunotherapy.
  • Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures (e.g., drug addition, chronic non-compliance, etc.).

Trial locations and contacts

46 sites in 5 countries.

46 sites in 5 countries

United States30 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • St. Alexis Medical Center-Mid Dakota Clinic PC

    Bismarck, North Dakota, 58501

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina - Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219

  • Kaiser Permanente Colorado

    Denver, Colorado, 80205

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Poudre Valley Cancer Center of the Rockies

    Fort Collins, Colorado, 80528

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Hendersonville Hematology and Oncology at Pardee

    Hendersonville, North Carolina, 28971

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • UCSD Moores Cancer Center

    La Jolla, California, 92037

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale Cancer Center

    New Haven, Connecticut, 06519

  • New York University Langone Medical Center

    New York, New York, 10016

  • Desert Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Kaiser Permanente NW

    Portland, Oregon, 97227

  • Rex Cancer Center UNC Healthcare

    Raleigh, North Carolina, 27607

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Pacific Cancer Care

    Salinas, California, 93901

  • Premiere Oncology

    Santa Monica, California, 90404

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • UMASS Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

India6 sites

  • Lifeline Multispeciality Hospitals

    Chennai, Tamil Nadu, 600096

  • Basavatarakam Indo-American Cancer Hospital

    Hyderabad, Andhra Pradesh, 500034

  • Jaslok Hospital & Research Centre

    Mumbai, Maharashtra, 400026

  • Shatabdi Superspeciality Hospital

    Nashik, Maharashtra, 422005

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Regional Cancer Center

    Thiruvananthapuram, Kerala, 695001

Other trials in India

Russia6 sites

  • State Budget Medical Institution of the Arkhangelsk Region

    Arkhangelsk, 163045

  • Chelyabinsk Regional Clinical Oncology Center

    Chelyabinsk, 454087

  • State Budget Medical Institution Clinical Oncology Center 1

    Krasnodar, 350040

  • Budget Medical Institution of the Omsk Region: Clinical Oncology Center

    Omsk, 644013

  • State Budget Medical Institution: Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • State Medical Institution: Tula Regional Oncology Center

    Tula, 300053

Other trials in Russia

Hungary3 sites

  • Semmelweis University Department of Diagnostic Radiology and Oncotherapy

    Budapest, 1078

  • Semmelweis University, 3rd Department of Internal Medicine

    Budapest, 1125

  • Hetenyi Geza Hospital 5004, Szolnok, Hungary

    Szolnok, 5004

Other trials in Hungary

Ukraine1 site

  • Zakarpattia Regional Clinical Oncology Center Department of Chemotherapy

    Uzhhorod, 88014

Other trials in Ukraine

About this study

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

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.

Read the detailed description

This will be a Phase III study with sample size recalculation after 100 events have occurred. The study will be open-label, randomized, controlled, multi-center and will be conducted at approximately 200 to 300 study sites (60 to 80 study sites in the first portion of the trial).

In the first portion of the study, a total of 150 patients with metastatic pancreatic cancer who have received no prior chemotherapy for this disease will be randomized in a 2:1 fashion to 1 of the 2 following treatment regimens:

  • Arm A: Gemcitabine 1000 mg/m2 weekly for 3 weeks of a 4 week cycle + ON 01910.Na 1800 mg/m2 via 2 hr continuous intravenous infusion (CIV) infusions administered twice weekly for 3 weeks of a 4 week cycle (approximately 100 patients)
  • Arm B: Gemcitabine only, 1000 mg/m2 weekly for 3 weeks of a 4 week cycle (approximately 50 patients).

Patients will be stratified at entry using the Eastern Cooperative Oncology Group (ECOG) performance status (ECOG scores of 0 1 vs. ECOG scores of 2; patients with higher scores will not be enrolled).

Patients will remain on study until disease progression or death from any cause, whichever comes first. Moreover, after treatment discontinuation for any cause, all patients will be followed until death.

After 150 patients have been enrolled, accrual will pause and patients will be followed until 100 deaths have occurred. At that time, the Data Safety Monitoring Committee (DSMC) will oversee a formal interim analysis to compare overall survival (OS) between the 2 groups and may recommend early stopping for futility. If the study continues after interim analysis, then the randomization scheme will continue up to 364 patients or the newly-calculated sample size. The maximum number of enrolled patients will be 650. The number of clinical sites may be expanded up to approximately 200 to 300 centers.

Patients in the gemcitabine-only arm (Arm B) will not be allowed to cross over to the combined treatment arm (Arm A). In addition, no palliative radiotherapy will be allowed during the trial.

The primary analysis will compare OS in the ON 01910.Na + gemcitabine arm (Arm A) vs. gemcitabine-only arm (Arm B) once an appropriate number of events has been reached. There are 2 secondary efficacy outcomes: progression-free survival (PFS) and objective response.

Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. Grade 3 and 4 hematologic toxicities and > Grade 2 non-hematologic toxicities will be monitored.

Being tested
ON 01910.Na, Gemcitabine
Keywords
pancreatic cancer, gemcitabine, ON 01910.Na, rigosertib sodium
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ON 01910.NaDrug

    Also called rigosertib sodium

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

  • GemcitabineDrug

    Also called Gemzar, Gemcitabine HCl

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

  • GemcitabineDrug

    Also called Gemzar, Gemcitabine HCl

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

Study groups in NCT01360853
Study groupRoleWhat they receive
Arm A: CombinationExperimentalArm A: Gemcitabine, 1000 mg/m2 weekly for 3 weeks of a 4 week cycle, + ON 01910.Na, 1800 mg/m2 via 2 hr CIV infusions administered twice weekly for 3 weeks of a 4 week cycle.
Receives: Drug: ON 01910.Na; Drug: Gemcitabine
Arm B: Gemcitabine onlyActive comparatorArm B: Gemcitabine only, 1000 mg/m2 weekly for 3 weeks of a 4 week cycle.
Receives: Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    This study's primary outcome is overall survival, defined as the time from randomization to death from any cause. All patients will be followed until death. Patients lost to follow-up will be censored at the time last known alive.

    Measured: 18 months

Secondary outcomes (7)

  1. Progression-free survival

    Progression-free survival is defined as the time from the randomization to documented disease progression or death. Patients who are alive and do not have disease progression by the clinical cutoff will be censored at the dates of their last tumor evaluation. Kaplan-Meier curves for PFS will be compared using a stratified log-rank test (stratified by ECOG status: 0-1 vs. 2). Hazard ratios and 95% confidence intervals will be estimated using stratified Cox proportional hazards models.

    Measured: 18 months

  2. Tumor size

    Objective tumor response rates using Response Evaluation Criteria In Solid Tumors (RECIST).

    Measured: 18 months

  3. Safety/tolerability

    Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03

    Measured: 18 months

  4. QOL questionnaire

    Quality of life (QOL) questionnaire, using the European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 version 3.

    Measured: 18 months

  5. Biomarkers

    In this study, archival tissue will be collected and analyzed in order to identify molecular characteristics of pancreas tumors, which may confer susceptibility or resistance to gemcitabine alone or in combination with ON 01910.Na.

    Measured: 18 months

  6. Population Pharmacokinetics

    Measurement of ON 01910.Na in plasma of all patients in Arm A 1 hour after starting ON 01910.Na infusion at Day 1 and Day 15 in Cycle 1 only.

    Measured: 18 months

  7. Full Pharmacokinetics

    At a limited number of sites, blood samples for measurement of ON 01910.Na and gemcitabine will be obtained at Cycle 1 Day 1 only, in a subset of 10 patients in Arm A, at the following 12 time-points: predose; 15 min after starting gemcitabine infusion; 30 min, immediately before ending gemcitabine infusion; 15 min after starting ON 01910.Na infusion; 30 min after ON 01910.Na infusion start; immediately before ending ON 01910.Na infusion; and, 15 min, 30 min, 1 hr, 2 hr, 4 hr and 8 hr after ending ON 01910.Na infusion.

    Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJun 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01360853
Sponsor's protocol ID
04-22
Other IDs
11PAN01
Acronym
ONTRAC
Status last verified
Aug 2016
First submitted
24 May 2011
Last updated
4 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Jimeno A, Chan A, Cusatis G, Zhang X, Wheelhouse J, Solomon A, Chan F, Zhao M, Cosenza SC, Ramana Reddy MV, Rudek MA, Kulesza P, Donehower RC, Reddy EP, Hidalgo M. Evaluation of the novel mitotic modulator ON 01910.Na in pancreatic cancer and preclinical development of an ex vivo predictive assay. Oncogene. 2009 Jan 29;28(4):610-8. doi: 10.1038/onc.2008.424. Epub 2008 Nov 24.

    PubMed 19029951

  • Jimeno A, Li J, Messersmith WA, Laheru D, Rudek MA, Maniar M, Hidalgo M, Baker SD, Donehower RC. Phase I study of ON 01910.Na, a novel modulator of the Polo-like kinase 1 pathway, in adult patients with solid tumors. J Clin Oncol. 2008 Dec 1;26(34):5504-10. doi: 10.1200/JCO.2008.17.9788. Epub 2008 Oct 27.

    PubMed 18955447

  • O'Neil BH, Scott AJ, Ma WW, Cohen SJ, Aisner DL, Menter AR, Tejani MA, Cho JK, Granfortuna J, Coveler AL, Olowokure OO, Baranda JC, Cusnir M, Phillip P, Boles J, Nazemzadeh R, Rarick M, Cohen DJ, Radford J, Fehrenbacher L, Bajaj R, Bathini V, Fanta P, Berlin J, McRee AJ, Maguire R, Wilhelm F, Maniar M, Jimeno A, Gomes CL, Messersmith WA. A phase II/III randomized study to compare the efficacy and safety of rigosertib plus gemcitabine versus gemcitabine alone in patients with previously untreated metastatic pancreatic cancer. Ann Oncol. 2016 Jun;27(6):1180. doi: 10.1093/annonc/mdw095. Epub 2016 Mar 3. No abstract available.

    PubMed 26945010

  • O'Neil BH, Scott AJ, Ma WW, Cohen SJ, Leichman L, Aisner DL, Menter AR, Tejani MA, Cho JK, Granfortuna J, Coveler L, Olowokure OO, Baranda JC, Cusnir M, Phillip P, Boles J, Nazemzadeh R, Rarick M, Cohen DJ, Radford J, Fehrenbacher L, Bajaj R, Bathini V, Fanta P, Berlin J, McRee AJ, Maguire R, Wilhelm F, Maniar M, Jimeno A, Gomes CL, Messersmith WA. A phase II/III randomized study to compare the efficacy and safety of rigosertib plus gemcitabine versus gemcitabine alone in patients with previously untreated metastatic pancreatic cancer. Ann Oncol. 2015 Dec;26(12):2505. doi: 10.1093/annonc/mdv477. Epub 2015 Oct 21. No abstract available.

    PubMed 26489442

  • O'Neil BH, Scott AJ, Ma WW, Cohen SJ, Aisner DL, Menter AR, Tejani MA, Cho JK, Granfortuna J, Coveler L, Olowokure OO, Baranda JC, Cusnir M, Phillip P, Boles J, Nazemzadeh R, Rarick M, Cohen DJ, Radford J, Fehrenbacher L, Bajaj R, Bathini V, Fanta P, Berlin J, McRee AJ, Maguire R, Wilhelm F, Maniar M, Jimeno A, Gomes CL, Messersmith WA. A phase II/III randomized study to compare the efficacy and safety of rigosertib plus gemcitabine versus gemcitabine alone in patients with previously untreated metastatic pancreatic cancer. Ann Oncol. 2015 Sep;26(9):1923-1929. doi: 10.1093/annonc/mdv264. Epub 2015 Jun 19.

    PubMed 26091808

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ON 01910.Na and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, run by Traws Pharma, Inc. at 46 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, India, Russia, Hungary, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360853, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.

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