NCT00102700

Brief Summary

The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2 pancreatic-cancer

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

2 years

First QC Date

February 1, 2005

Last Update Submit

April 28, 2009

Conditions

Pancreatic CancerAdenocarcinoma

Keywords

cancersolid tumoradvanced solid tumorpancreaspancreatic cancercancer of the pancreas

Outcome Measures

Primary Outcomes (1)

  • Document progression free survival after treatment with ARQ 501 and gemcitabine

Secondary Outcomes (1)

  • Document safety and efficacy of ARQ 501 in combination with gemcitabine

Interventions

ARQ 501 in combination with gemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of South Alabama

Mobile, Alabama, 36693, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, 92270, United States

Location

Scripps Cancer Center

San Diego, California, 92121, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Unversity of Kentucky Medical Center - Markey Center

Lexington, Kentucky, 40536, United States

Location

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Jeffrey Meyerhardt

Boston, Massachusetts, 02115, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenocarcinomaNeoplasms

Interventions

beta-lapachoneGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2005

First Posted

February 2, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations

US(15)