UMIN ID: UMIN000002152
Registered date:01/07/2009
A phase 1 study of combination therapy with gemcitabine and candesartan in patients with pancreatic cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Pancreatic cancer |
| Date of first enrollment | 2009/07/01 |
| Target sample size | 24 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Combination therapy with gemcitabine and candesartan |
Outcome(s)
| Primary Outcome | Dose limiting toxicity, maximum tolerated dose, recommended dose |
|---|---|
| Secondary Outcome | Adverse effects, response rate, disease control rate, progression free survival, overall survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with systolic blood pressure < 100mmHg 2) Patients with an active concomitant infection 3) Patients with digestive ulcer or gastrointestinal bleeding 4) Patients with severe heart or renal disease 5) Patients with an active pulmonary fibrosis or interstitial pneumonia 6) Patients with a previous history of a severe drug hypersensitivity 7) Patients with an active concomitant malignancy 8) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 9) Patients with hypertension 10) Patients who received ACE or ARB 11) Patients with uncontrollable massive pleural effusion or massive ascites 12) Inappropriate patients for entry on this study in the judgement of the investigator |
Related Information
| Primary Sponsor | University of Tokyo, Department of Gastroenterology |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yousuke Nakai |
| Address | Japan |
| Telephone | |
| ynakai-tky@umin.ac.jp | |
| Affiliation | University of Tokyo Department of Gastroenterology |
| scientific contact | |
| Name | Hiroyuki Isayama |
| Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan |
| Telephone | |
| Affiliation | University of Tokyo Department of Gastroenterology |