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A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer, Adenocarcinoma

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Trial Information

A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in
adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.
The study objectives are:

Primary Objective:

- Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination
with gemcitabine.

Secondary Objectives:

- Determine time to tumor progression (TTP) of patients treated with ARQ 501 in
combination with gemcitabine

- Further characterize the safety of ARQ 501 in combination with gemcitabine

Inclusion Criteria:

- Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic

- Be treatment-naïve.

- Have measurable disease per RECIST Criteria.

- Be ≥18 years old.

- Have a Karnofsky Performance Status (KPS) of ≥70%.

- Have an estimated life expectancy of ≥12 weeks.

- Be male or a non-pregnant, non-lactating female patient. Patients who are fertile
agree to use an effective barrier method of birth control (e.g., latex condom,
diaphragm, or cervical cap) to avoid pregnancy.

- Have a negative serum or urine pregnancy test within 7 days prior to the first dose
of study drug (if patient is a female of childbearing potential).

- Sign a written informed consent form.

- Have adequate organ function as indicated by acceptable laboratory values obtained
within 7 days prior to the first dose of study drug.

Exclusion Criteria:

- Have received any prior therapy for the treatment of their pancreatic malignancy
(including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major
surgery, or irradiation, whether conventional or investigational).

- Have an active, uncontrolled systemic infection considered opportunistic, life
threatening or clinically significant at the time of treatment.

- Are pregnant or lactating.

- Have a psychiatric disorder(s) that would interfere with consent, study
participation, or follow-up.

- Have any other severe concurrent disease, which, in the judgment of the investigator,
would make the patient inappropriate for entry into this study.

- Have symptomatic or untreated central nervous system (CNS) metastases.

- Have a known hypersensitivity to gemcitabine.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Document progression free survival after treatment with ARQ 501 and gemcitabine


United States: Food and Drug Administration

Study ID:

ARQ 501-212



Start Date:

January 2005

Completion Date:

January 2007

Related Keywords:

  • Pancreatic Cancer
  • Adenocarcinoma
  • cancer
  • solid tumor
  • advanced solid tumor
  • pancreas
  • pancreatic cancer
  • cancer of the pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Baylor College of Medicine Houston, Texas  77030
Moores UCSD Cancer Center La Jolla, California  92093-0658
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
Jacobi Medical Center Bronx, New York  10461
Scripps Cancer Center La Jolla, California  92037
University of Chicago Medical Center Chicago, Illinois  60637
University of Kentucky Medical Center Lexington, Kentucky  40536-0093
Virginia Cancer Institute Richmond, Virginia  23230
Desert Hematology Oncology Medical Group, Inc. Rancho Mirage, California  92270
VA San Diego Healthcare System San Diego, California  92161
University of South Alabama Mobile, Alabama  36693
Unversity of Kentucky Medical Center - Markey Center Lexington, Kentucky  40536
The Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland  21231
Jeffrey Meyerhardt Boston, Massachusetts  02115