Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
This study has been terminated.
(FDA Hold May 2007)
Sponsor:
Point Therapeutics
Information provided by:
Point Therapeutics
ClinicalTrials.gov Identifier:
NCT00116389
First received: June 28, 2005
Last updated: June 7, 2007
Last verified: June 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Neoplasm Metastasis Adenocarcinoma |
Drug: talabostat mesylate tablets Drug: gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Point Therapeutics:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116389
Show 28 Study Locations
Show 28 Study LocationsSponsors and Collaborators
Point Therapeutics
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00116389 History of Changes |
| Other Study ID Numbers: | PTH-320 |
| Study First Received: | June 28, 2005 |
| Last Updated: | June 7, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Point Therapeutics:
|
pancreatic cancer cancer of the pancreas adenocarcinoma of the pancreas |
pancreatic neoplasms Metastatic pancreatic cancer (Stage IV) Stage IV Adenocarcinoma of the Pancreas |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Neoplasm Metastasis Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplastic Processes Pathologic Processes Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Pancreatin Pancrelipase Gemcitabine Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013