Adenocarcinoma, Neoplasm Metastasis, Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, cancer of the pancreas, adenocarcinoma of the pancreas, pancreatic neoplasms, Metastatic pancreatic cancer (Stage IV), Stage IV Adenocarcinoma of the Pancreas
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.
Interventions
DRUGtalabostat mesylate tablets
DRUGgemcitabine
Sponsors
Point Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | — |
| progression-free survival (PFS) | — |
| quality of life | — |
| pain | — |
| performance status | — |
Countries
United States
Outcome results
None listed