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Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma (AxitinibACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Bhumsuk Keam, Seoul National University Hospital

Brief Summary:
To understand efficacy of axitinib in recurred or metastatic adenoid cystic carcinoma

Condition or disease Intervention/treatment Phase
Recurrent ACC, metastaticACC, Unreaectable ACC Drug: Axitinib Other: Observation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids
Drug Information available for: Axitinib

Arm Intervention/treatment
Experimental: axitinib
Axitinib 5 mg twice (10mg) daily po medication until progression or development of unacceptable toxicity (4 weeks is considered as one cycle).
Drug: Axitinib
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.
Other: Observation
this group is observational ones.

Primary Outcome Measures :
  1. Progression-free survival (PFS) rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
  2. response rate [ Time Frame: 1 year ]
  3. overall survival [ Time Frame: 1 year ]
  4. duration of response [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed adenoid cystic carcinoma
  2. Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, MIBI scan) or X-ray taken >9 months prior to baseline compared to a previous image. Progression must be documented according to RECIST 1.1 criteria.
  3. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent
  4. Presence of at least one measurable target lesion for further evaluation according to RECIST 1.1 criteria
  5. 18 years or older
  6. ECOG performance status 0, 1
  7. Adequate organ function

    • ANC ≥ 1500/ μL
    • Platelets ≥100,000/ μL
    • Hemoglobin ≥ 9.0 g/dL
    • Serum creatinine ≤1.5 x ULN
    • Serum bilirubin ≤1.5 x ULN
    • AST, ALT, ≤3.0 x ULN (regardless of liver metastasis)
  8. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
  9. A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

  1. A patient with no measurable disease
  2. Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry)
  3. A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding
  4. A pregnant or lactating patient
  5. A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential)
  6. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study
  7. A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin, early gastric cancer and cervical carcinoma in situ.
  8. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.
  9. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months.
  10. A patient with organ transplantation requiring immunosuppressive therapy

Information from the National Library of Medicine

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 identifier (NCT number): NCT02859012

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Korea, Republic of
Department of Internal Medicine, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Bhumsuk Kim, Ph.D. Seoul National University Hospital
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Responsible Party: Bhumsuk Keam, Clinical Assistant Professor, Seoul National University Hospital Identifier: NCT02859012    
Other Study ID Numbers: Axitinib in ACC
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action