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

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Axitinib

Criteria

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