Clinical trial · Interventional
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
A Phase 1b/2 Multicenter, International, Randomized, Double Blind, Placebo-Controlled, Study of Gemcitabine Combined With PEGPH20 Compared to Gemcitabine Combined With Placebo in Patients With Stage IV Previously Untreated Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients. Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.
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 |
|---|---|---|---|
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| PEGPH20 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- description
- Gemcitabine + Placebo
- interventionNames
- Drug: Gemcitabine
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- PEGPH20
- description
- PEGPH20+Gemcitabine
- interventionNames
- Drug: Gemcitabine
- Drug: PEGPH20
Primary outcomes (2)
- measure
- Number of Participants With a Dose-limiting Toxicity (DLT)
- timeFrame
- first 4 weeks of Cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patients with histologically confirmed Stage IV adenocarcinoma of the pancrease previously untreated for metastatic disease * One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria * Life expectancy of at least 3 months * Signed, written IRB/EC-approved informed consent * A negative serum pregnancy test, if female Key Exclusion Criteria: * Known brain metastasis * New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 12 months * Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy * Known allergy to hyaluronidase * Women currently pregnant or breast feeding
References
Publications (0)
Data not yet available