Clinical trial · Interventional
A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer
A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer
NCT00556023CI-TRIAL-00007105completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-675,206 and gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CP-675,206 and gemcitabine
- interventionNames
- Drug: CP-675,206 and gemcitabine
Primary outcomes (1)
- measure
- Dose Limiting Toxicities: assessed through adverse event data collected weekly
- timeFrame
- 8 week intervals
Secondary outcomes (9)
- measure
- HAHA Response to CP-675,206:
- timeFrame
- 12 months
- measure
- Lymphocyte Subset Analysis:
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic pancreatic cancer * Patient must have adequate bone marrow, liver and kidney function * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 * Chemotherapy naive * Inoperable pancreatic cancer Exclusion Criteria: * Patient must not have received prior systemic therapy for pancreatic cancer * Patient must not have previously received anti-CTLA4 therapy * History of chronic inflammatory or autoimmune disease
References
Publications (1)
- DERIVEDAglietta M, Barone C, Sawyer MB, Moore MJ, Miller WH Jr, Bagala C, Colombi F, Cagnazzo C, Gioeni L, Wang E, Huang B, Fly KD, Leone F. A phase I dose escalation trial of tremelimumab (CP-675,206) in combination with gemcitabine in chemotherapy-naive patients with metastatic pancreatic cancer. Ann Oncol. 2014 Sep;25(9):1750-1755. doi: 10.1093/annonc/mdu205. Epub 2014 Jun 6. PMID 24907635