NCT01524692

Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma

A Phase II Pilot Study of Dovitinib (TKI258) in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to improve survival of patients with recurrent or metastatic Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational drug, TKI258, in treating ACC.

Detailed description

Adenoid cystic carcinoma (ACC) is an uncommon malignancy that arises in secretory glands. The most common sites for the disease are the major and minor salivary glands but these tumors may also arise in the nasal cavity, lacrimal gland, tracheobronchial tree, breast or vulva. The mainstay of treatment for localized ACC is surgical resection often followed by post-operative radiotherapy. Although this leads to an initially high rate of local control, the 5-year disease-free survival rate is 50-75%. In addition, a significant proportion of the patients develop distant metastases, most frequently in the lung. Compared to other malignancies, ACC tends to grow more slowly. Thus, patients often do well in the short-term but long-term prognosis remains guarded and most succumb to the disease within 10-15 years. To date, systemic therapies have proven to be largely ineffective against recurrent and metastatic ACC. Dovitinib is a broad-targeted-profiled RTK inhibitor active against these three RTKs (VEGF, FGF and PDGF) involved in tumor cell growth. Based on its potency as an inhibitor of these RTKs both in vitro and in vivo, and the compound's oral availability, several clinical trials of dovitinib are underway. This phase II trial will test the hypothesis that dovitinib will be active against this disease. The rationale is based on pre-clinical studies that suggest that dovitinib suppresses tumor growth by blocking constitutive signaling of the fibroblast growth factor receptor-1 (FGFR1) and animal studies in which the drug proved to be active against primary ACC xenografts.

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	Dovitinib (TKI258)	500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-01-01
• Completion: 2015-12-01
• First posted: 2012-02-02
• Last updated: 2018-11-09
• Results posted: 2018-05-07

Locations

1 site across 1 country: United States