A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Subjects With Locally Advanced, Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC) (IND 71976)
PRIMARY OBJECTIVES:
I. To evaluate the efficacy by means of response rate (based on RECIST 1.1 criteria) of
vorinostat in the treatment of patients with locally advanced, recurrent or metastatic
adenoid cystic carcinoma (ACC).
SECONDARY OBJECTIVES:
I. To characterize the safety and tolerability of vorinostat in this patient population.
II. To assess the time to tumor response (TTR). III. To assess the response duration (RD).
IV. To evaluate progression free survival (PFS). V. To assess overall survival (OS).
TERTIARY OBJECTIVES:
I. To assess the association between a metabolic response by PET/CT after one cycle of
chemotherapy and subsequent best tumor response according to standard anatomic response
evaluation criteria (RECIST).
II. To assess the association between a metabolic response by PET/CT after the first and
second chemotherapy cycle and PFS.
III. To assess the association between response to vorinostat treatment and biomarkers such
as c-kit, HER2/neu, EGFR, p21, p16, p53, c-myb, TBP2 and HR23B on tumor paraffin blocks.
IV. To assess the association between response to vorinostat treatment and genomic
biomarkers in tumor tissue.
V. To characterize molecular mechanisms of vorinostat response in ACC and identify novel
therapeutic strategies.
VI. To develop a series of primary tumor grafts from trial participants in support of future
ACC research and experimental therapeutics.
VII. To assess the association between response to vorinostat treatment and detection of the
unique ACC translocation t (6;9) by FISH analysis.
OUTLINE:
Patients receive oral vorinostat once daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 6 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response according to RECIST 1.1 criteria
Up to 180 days
No
Patricia LoRusso
Principal Investigator
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
NCI-2012-02981
NCT01175980
August 2010
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |