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

Sponsor

Point Therapeutics (Industry)

Overall Status

Terminated

CT.gov ID

NCT00116389

Collaborator

(none)

Enrollment

Locations

2.1

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Neoplasm Metastasis Adenocarcinoma	Drug: talabostat mesylate tablets Drug: gemcitabine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcome Measures

6 month survival []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest Alabama Cancer Center, PC	Florence	Alabama	United States	35630
2	Northwest Alabama Cancer Center, PC	Muscle Shoals	Alabama	United States	35661
3	Oncology Associates, PC	Hartford	Connecticut	United States	06106
4	Palm Beach Institute of Hematology and Oncology	Boynton Beach	Florida	United States	33435
5	Cancer Center of Florida	Ocoee	Florida	United States	34761
6	Hematology Oncology Associates of Central Brevard	Rockledge	Florida	United States	32955
7	Gulfcoast Oncology Associates	St. Petersburg	Florida	United States	33705
8	Yagnesh V. Oza, MD	Mt. Vernon	Illinois	United States	62864
9	Indiana Oncology Hematology Consultants	Indianapolis	Indiana	United States	46202
10	Cancer Care Center, Inc.	New Albany	Indiana	United States	47150
11	Medical Oncology LLC	Baton Rouge	Louisiana	United States	70809
12	Huron Medical Center	Port Huron	Michigan	United States	48060
13	Billings Clinic	Billings	Montana	United States	59101
14	Monmouth Medical Center	Long Branch	New Jersey	United States	07740
15	New York Oncology Hematology/Albany Regional Cancer Center	Albany	New York	United States	12208
16	Hematology-Oncology Associates of Rockland	New City	New York	United States	10956
17	Dayton Oncology and Hematology	Kettering	Ohio	United States	45409
18	Lawrence M. Stallings, MD	Wooster	Ohio	United States	44691
19	Trilogy Cancer Center	Wooster	Ohio	United States	44691
20	Providence Portland Medical Center	Portland	Oregon	United States	97213-2933
21	Oregon Clinic, The	Portland	Oregon	United States	97213
22	Cancer Center of the Carolinas	Greenville	South Carolina	United States	29615
23	Mary Crowley Medical Research Center	Dallas	Texas	United States	75201
24	Texas Oncology, PA, Presbyterian	Dallas	Texas	United States	75231
25	Baylor College of Medicine	Houston	Texas	United States	77030
26	Elkins Pancreas Center	Houston	Texas	United States	77030
27	Saint Luke's Episcopal Hospital	Houston	Texas	United States	77030
28	Cancer Care Northwest	Spokane	Washington	United States	99218