Clinical trial · Interventional
OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas
Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was pending major changes and was on hold, pending activation; administratively withdrawn; will be submitted as a new protocol if study is revised.
Summary
Brief summary (as posted)
OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth. Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with 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, Metastatic | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Erlotinib | Drug | — | UNRESOLVED |
| Gemcitabine, Erlotinib, OSI-906 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine, Erlotinib, OSI-906
- description
- Experimental treatment arm
- interventionNames
- Drug: Gemcitabine, Erlotinib, OSI-906
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine, Erlotinib
- description
- Standard treatment arm
- interventionNames
- Drug: Gemcitabine, Erlotinib
Primary outcomes (2)
- measure
- Number of patients with adverse events as a measure of safety and tolerability
- timeFrame
- 1 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic pancreatic ductal adenocarcinoma * Measurable disease * Life expectancy \> 12 weeks * Normal organ and marrow function * Fasting blood glucose \</= 150 mg/dL * Able to swallow pills Exclusion Criteria: * Prior chemotherapy or radiotherapy for treatment of pancreatic cancer * Receiving any other experimental agent * Known brain metastases * History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906 * Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea) * Use of enzyme-inducing anti-epileptic drugs * Diabetes mellitus which requires the use of exogenous insulin for glucose control * Major surgery within 4 weeks of the start of study treatment * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Use of strong or moderate CYP1A2 inhibitors/inducers * Pregnant or breast feeding * History of a different malignancy unless disease-free for at least 3 years * HIV positive
References
Publications (0)
Data not yet available