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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Pancreatic Adenocarcinoma

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Trial Information

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


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.


Inclusion Criteria:



- 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.

- 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.

Exclusion Criteria:

- 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.

- 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.).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Wells Messersmith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Anschutz Cancer Pavilion

Authority:

United States: Food and Drug Administration

Study ID:

04-22

NCT ID:

NCT01360853

Start Date:

May 2011

Completion Date:

December 2014

Related Keywords:

  • Metastatic Pancreatic Adenocarcinoma
  • pancreatic cancer
  • gemcitabine
  • ON 01910.Na
  • rigosertib sodium
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Colorado Cancer CenterDenver, Colorado  80262
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Rochester Medical CenterRochester, New York  14642
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Seattle Cancer Care AllianceSeattle, Washington  98109
McLeod Regional Medical CenterFlorence, South Carolina  29501
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Medical University of South Carolina - Hollings Cancer CenterCharleston, South Carolina  29425
UCSD Moores Cancer CenterLa Jolla, California  93093
Karmanos Cancer InstituteDetroit, Michigan  48201
Premiere OncologySanta Monica, California  90404
University of Kansas Cancer CenterKansas City, Kansas  66160
New York University Langone Medical CenterNew York, New York  10016
University of North Carolina Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599
University of Hawaii Cancer CenterHonolulu, Hawaii  96813
UMass Medical SchoolWorcester, Massachusetts  01655
Kaiser Permanente NWPortland, Oregon  
Levine Cancer InstituteCharlotte, North Carolina  28211
Desert Comprehensive Cancer CenterPalm Springs, California  92262
Cone Health Cancer CenterGreensboro, North Carolina  
Kaiser Permanente ColoradoDenver, Colorado  80205
Hendersonville Hematology and Oncology at PardeeHendersonville, North Carolina  28971
Rex Cancer Center UNC HealthcareRaleigh, North Carolina  27607
St. Alexis Medical Center-Mid Dakota Clinic PCBismarck, North Dakota  58501
University of Cincinnati Cancer CenterCincinnati, Ohio  45219
Pacific Cancer CareSalinas, California  93901
Poudre Valley Cancer Center of the RockiesFort Collins, Colorado  80528