Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety
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ClinicalTrials.gov Identifier: NCT02883374 |
Recruitment Status : Unknown
Verified August 2017 by Dong mei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : August 30, 2016
Last Update Posted : August 31, 2017
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Sponsor:
Dong mei
Information provided by (Responsible Party):
Dong mei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tracking Information | |||||
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First Submitted Date ICMJE | August 25, 2016 | ||||
First Posted Date ICMJE | August 30, 2016 | ||||
Last Update Posted Date | August 31, 2017 | ||||
Study Start Date ICMJE | November 2016 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Disease control rate [ Time Frame: through study completion, an average of 33 months ] percentage of patients who get complete remission, partial remission and stable disease.
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety | ||||
Official Title ICMJE | Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety | ||||
Brief Summary | The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then overall survival, event-free survival are accessed for efficiency, and laboratory tests about the function of vital organs are accessed for safety. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Adenocystic Carcinoma | ||||
Intervention ICMJE | Drug: Chidamide
Other Name: epidaza
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Study Arms ICMJE | Experimental: Chidamide
Patients of advanced cephalic and cervical adenocystic carcinoma are given Chidamide 30mg,biw, then the efficacy and safety will be accessed.
Intervention: Drug: Chidamide
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2020 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Liver: Total bilirubin ≤ 1.5 times of the normal maximum, ALT and AST≤ 2.5 times of the normal maximum. (ALT/AST≤ 5 times of the normal maximum for patients with infiltrative liver disease) Kidney: Serum creatinine ˂ 1.5 folds of the normal maximum; creatinine clearance rate ≥50ml/min (calculated by Cockroft-Gault10 formula) Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02883374 | ||||
Other Study ID Numbers ICMJE | CancerIHCAMS16-053/1132 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Dong mei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Dong mei | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | ||||
Verification Date | August 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |