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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-675,206 and gemcitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-675,206 and gemcitabine | Drug | Escalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities: assessed through adverse event data collected weekly | 8 week intervals |
| Measure | Description | Time Frame |
|---|---|---|
| HAHA Response to CP-675,206: | 12 months | |
| Lymphocyte Subset Analysis: | 12 months | |
| Cytokine Analysis: |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24907635 | Derived | Aglietta 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| 12 months |
| Pharmacogenomic Analysis: | 1 month |
| Overall Survival: | 12 months |
| Pharmacokinetics of CP-675,206 and Gemcitabine: | 2 months |
| Best Overall Response: | 3 months |
| Duration of Tumor Response: | 3 months |
| Progression-Free Survival: | 5 months |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| Research Site | Montreal | Quebec | H3T 1E2 | Canada |
| Research Site | Candiolo (TO) | 10060 | Italy |
| Research Site | Roma | 00168 | Italy |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |