Clinical Trial: A Phase II Study of Dovitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of DOVitinib in REcurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands (DOVE)

Brief Summary: This is a non-randomized, phase II, open label study of dovitinib in patients with progressive, recurrent and/or metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to assess the anti-cancer effects of dovitinib in this population in order to evaluate whether dovitinib is worthy of further study in patients with progressive ACC.

Detailed Summary:
Sponsor: Ontario Clinical Oncology Group (OCOG)

Current Primary Outcome: Clinical Benefit Rate [ Time Frame: 2 years ]

The primary outcome measure is the clinical benefit rate, defined as an objective response (complete [CR] or partial [PR]) or stable disease [SD] of ≥6 months duration according to the RECIST version 1.1 criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival [ Time Frame: From the date the patient first receives study medication to the date of death or date of progression according to RECIST or symptomatic deterioration; estimated to be after 12 weeks of treatment ]
  • Overall Survival [ Time Frame: From the date the patient first receives study medication to the date of death; patients will be followed up for survival for up to 2 years after disease progression ]
  • Safety and tolerability [ Time Frame: From the date the patient first receives study medication to the date the patient completes the study; patients will be followed up for survival for up to 2 years after disease progression ]
    Patients will be evaluated for toxicity. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occuring, serious and severe events of interest.


Original Secondary Outcome: Same as current

Information By: Ontario Clinical Oncology Group (OCOG)

Dates:
Date Received: August 23, 2012
Date Started: November 2012
Date Completion:
Last Updated: September 16, 2015
Last Verified: September 2015