Clinical Trial: Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized Phase II Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma
Brief Summary: To understand efficacy of axitinib in recurred or metastatic adenoid cystic carcinoma
Detailed Summary:
Adenoid cystic carcinoma (ACC) is a rare variant of adenocarcinoma that occurs in secretory glands such as in salivary glands. Although ACC is histologically low grade and slow-growing, more than half of patients eventually have recurrent and/or metastatic disease.
The natural course of metastatic disease with ACC is relatively indolent; however, most patients with metastatic disease ultimately die from their cancer. The management of recurred / metastatic ACC is a distinct therapeutic challenge because of its insidious local growth pattern, propensity for perineural involvement, tendency for distant metastasis, and pronounced ability to recur over a prolonged period.
2. Current treatment
The role of systemic chemotherapy in ACC is very limited and objective response to any cytotoxic or molecular targeted agent is infrequent, and the optimum regimen is unclear. Because of the rarity of ACC, there are few clinical trials investigating the efficacy of systemic chemotherapy. Recurrent/metastatic ACC is an incurable disease with no standard treatments.
VEGF is highly expressed in ACC and its expression correlates with stage, tumor size, vascular invasion, recurrence and metastasis. High expression of VEGF and Ki-67 were independent poor prognostic factors in ACC. MYB/NFIB translocation has recently identified in ACC and MYB protein over expression was found in ACC. MYB over-expression in ACC has been correlated to the increased expression of genes involved in vascular endothelial growth factor (VEGF), KIT . More than 70% of ACCs highly express the oncogenic transcription factor c-myb, which drives expression of genes that activate VEGFR and c-kit pathways.
Several lines of eviden
Sponsor: Seoul National University Hospital
Current Primary Outcome: Progression-free survival (PFS) rate [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: July 28, 2016
Date Started: September 2016
Date Completion: August 2020
Last Updated: January 13, 2017
Last Verified: January 2017
