Clinical trial · Interventional
A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
NCT00536770CI-TRIAL-00000954suspendedPhase 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): DSMB
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol + gemcitabine | Drug | — | UNRESOLVED |
| calcitriol + gemcitabine + erlotinib | Drug | — | UNRESOLVED |
| Placebo + gemcitabine | Drug | — | UNRESOLVED |
| placebo + gemcitabine + erlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- A
- description
- Placebo + gemcitabine
- interventionNames
- Drug: Placebo + gemcitabine
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Placebo + gemcitabine + erlotinib
- interventionNames
- Drug: placebo + gemcitabine + erlotinib
- type
- ACTIVE_COMPARATOR
- label
- C
- description
- DN-101 + gemcitabine
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer * Performance status 0, 1,or 2 * Adequate bone marrow, renal and hepatic function Exclusion Criteria: * Prior chemotherapy or radiation therapy for pancreatic cancer * Prior treatment for other cancers in last 6 months * Cancer of the brain or spine * Active uncontrolled infection * Hypercalcemia
References
Publications (0)
Data not yet available
No reference posted for this study.