Clinical trial · Interventional
Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
NCT00116389CI-TRIAL-00000749terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): FDA Hold May 2007
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Neoplasm Metastasis | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| talabostat mesylate tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 6 month survival
Secondary outcomes (5)
- measure
- overall survival
- measure
- progression-free survival (PFS)
- measure
- quality of life
- measure
- pain
- measure
- performance status
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.