Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma (AxitinibACC)
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|ClinicalTrials.gov Identifier: NCT02859012|
Recruitment Status : Unknown
Verified June 2018 by Bhumsuk Keam, Seoul National University Hospital.
Recruitment status was: Active, not recruiting
First Posted : August 8, 2016
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent ACC, metastaticACC, Unreaectable ACC||Drug: Axitinib Other: Observation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||August 2020|
Axitinib 5 mg twice (10mg) daily po medication until progression or development of unacceptable toxicity (4 weeks is considered as one cycle).
Dosing schedule: 5mg twice per day orally (4 weeks is considered as 1 cycle)
Other Name: Inlyta
Active Comparator: observation
Observation. if disease progression is detected, cross-over will be permitted.
this group is observational ones.
- Progression-free survival (PFS) rate [ Time Frame: 6 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
- response rate [ Time Frame: 1 year ]
- overall survival [ Time Frame: 1 year ]
- duration of response [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859012
|Korea, Republic of|
|Department of Internal Medicine, Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Bhumsuk Kim, Ph.D.||Seoul National University Hospital|