UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002152 |
|---|---|
| Receipt number | R000002632 |
| Scientific Title | A phase 1 study of combination therapy with gemcitabine and candesartan in patients with pancreatic cancer |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2015/12/11 08:20:32 |
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Basic information
Public title
A phase 1 study of combination therapy with gemcitabine and candesartan in patients with pancreatic cancer
Acronym
GECA-1 study
Scientific Title
A phase 1 study of combination therapy with gemcitabine and candesartan in patients with pancreatic cancer
Scientific Title:Acronym
GECA-1 study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the safety of combination therapy with gemcitabine and candesartan and determine the maximum tolerated dose and the recommended dose.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Dose limiting toxicity, maximum tolerated dose, recommended dose
Key secondary outcomes
Adverse effects, response rate, disease control rate, progression free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy with gemcitabine and candesartan
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with non-resectable or post-operative recurrent pancreatic cancer
2) Patients with pathologically proven or graphically confirmed pancreatic cancer
3) Patients with no prior therapy except surgery
4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
5) Patients of age >= 20 years
6) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= the upper limit of normal, and potassium <= the upper limit of normal
7) Written informed consent is required from all patients.
Key exclusion 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
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yousuke Nakai |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
ynakai-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 01 | Day |
Last modified on
| 2015 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002632
