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Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Primary Purpose

Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
talabostat mesylate tablets
gemcitabine
Sponsored by
Point Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, cancer of the pancreas, adenocarcinoma of the pancreas, pancreatic neoplasms, Metastatic pancreatic cancer (Stage IV), Stage IV Adenocarcinoma of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men or women age ≥18 years Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas Measurable disease defined per RECIST Karnofsky Performance Status ≥50 Expected survival ≥12 weeks Provide written informed consent Exclusion Criteria: CNS metastases Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer Radiation therapy to >25% of the bone marrow Clinically significant laboratory abnormalities Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry. Pregnancy or lactation

Sites / Locations

  • Northwest Alabama Cancer Center, PC
  • Northwest Alabama Cancer Center, PC
  • Oncology Associates, PC
  • Palm Beach Institute of Hematology and Oncology
  • Cancer Center of Florida
  • Hematology Oncology Associates of Central Brevard
  • Gulfcoast Oncology Associates
  • Yagnesh V. Oza, MD
  • Indiana Oncology Hematology Consultants
  • Cancer Care Center, Inc.
  • Medical Oncology LLC
  • Huron Medical Center
  • Billings Clinic
  • Monmouth Medical Center
  • New York Oncology Hematology/Albany Regional Cancer Center
  • Hematology-Oncology Associates of Rockland
  • Dayton Oncology and Hematology
  • Lawrence M. Stallings, MD
  • Trilogy Cancer Center
  • Providence Portland Medical Center
  • Oregon Clinic, The
  • Cancer Center of the Carolinas
  • Mary Crowley Medical Research Center
  • Texas Oncology, PA, Presbyterian
  • Baylor College of Medicine
  • Elkins Pancreas Center
  • Saint Luke's Episcopal Hospital
  • Cancer Care Northwest

Outcomes

Primary Outcome Measures

6 month survival

Secondary Outcome Measures

overall survival
progression-free survival (PFS)
quality of life
pain
performance status

Full Information

First Posted
June 28, 2005
Last Updated
June 7, 2007
Sponsor
Point Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00116389
Brief Title
Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
Official Title
An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Why Stopped
FDA Hold May 2007
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Point Therapeutics

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma
Keywords
pancreatic cancer, cancer of the pancreas, adenocarcinoma of the pancreas, pancreatic neoplasms, Metastatic pancreatic cancer (Stage IV), Stage IV Adenocarcinoma of the Pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
talabostat mesylate tablets
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Primary Outcome Measure Information:
Title
6 month survival
Secondary Outcome Measure Information:
Title
overall survival
Title
progression-free survival (PFS)
Title
quality of life
Title
pain
Title
performance status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women age ≥18 years Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas Measurable disease defined per RECIST Karnofsky Performance Status ≥50 Expected survival ≥12 weeks Provide written informed consent Exclusion Criteria: CNS metastases Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer Radiation therapy to >25% of the bone marrow Clinically significant laboratory abnormalities Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry. Pregnancy or lactation
Facility Information:
Facility Name
Northwest Alabama Cancer Center, PC
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
Northwest Alabama Cancer Center, PC
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Oncology Associates, PC
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Palm Beach Institute of Hematology and Oncology
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Cancer Center of Florida
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Hematology Oncology Associates of Central Brevard
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Gulfcoast Oncology Associates
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Yagnesh V. Oza, MD
City
Mt. Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Indiana Oncology Hematology Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Cancer Care Center, Inc.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Medical Oncology LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Huron Medical Center
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
New York Oncology Hematology/Albany Regional Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Hematology-Oncology Associates of Rockland
City
New City
State/Province
New York
ZIP/Postal Code
10956
Country
United States
Facility Name
Dayton Oncology and Hematology
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Lawrence M. Stallings, MD
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Trilogy Cancer Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2933
Country
United States
Facility Name
Oregon Clinic, The
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Texas Oncology, PA, Presbyterian
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Elkins Pancreas Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Saint Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

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