Dovitinib in Adenoid Cystic Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Yung-Jue Bang, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01417143
First received: August 9, 2011
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

The purpose of this phase II study of TKI258 (Dovitinib) in adenoid cystic carcinoma is to evaluate the efficacy of TKI258 (Dovitinib).


Condition Intervention Phase
Adenoid Cystic Carcinoma
Drug: TKI258 (Dovitinib):
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of TKI258 (Dovitinib) Monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    To determine 4month progression-free survival of TKI258 (Dovitinib) when administered as monotherapy in patients with unresectable adenoid cystic carcinoma


Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    CT scan will be evaluated every 2 cycles (per 8 weeks)till progression. Reponse rate will be evaluated by RECIST criteria


Estimated Enrollment: 33
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258 (Dovitinib)
TKI258 (Dovitinib): 500 mg daily po medication with 5 days on/2 days off schedule. TKI258 (Dovitinib) will be provided by Norvatis for the study purpose. One cycle consists of 4 weeks
Drug: TKI258 (Dovitinib):
TKI258 (Dovitinib): 500 mg daily po medication with 5 days on/2 days off schedule. TKI258 (Dovitinib) will be provided by Norvatis for the study purpose. One cycle consists of 4 weeks

Detailed Description:

open, uncontrolled, multi-center, phase II study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenoid cystic carcinoma
  • Local, locally advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, MIBI scan) taken 2 to 12 months prior to baseline compared to a previous scan taken at any time in the past. Progression must be documented according to RECIST criteria.
  • Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and who is previously treated with chemotherapy or local treatment (e.g. transarterial chemoembolization)
  • Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
  • 18 years or older
  • ECOG performance status 0, 1
  • Previous treatment with chemotherapy, targeted agents, loco-regional therapy (e.g. chemoembolization) are permitted providing that toxicity has resolved to < or = grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.
  • Adequate organ function
  • A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
  • A patient who signed the informed consent prior to the participation of the study and who understands that he or she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

  • A patient with no measurable disease
  • 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)
  • A patient with previous active or passive immunotherapy
  • A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding
  • A pregnant or lactating patient
  • 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)
  • A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study
  • A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin and cervical carcinoma in situ.
  • 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.
  • 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.
  • Ongoing cardiac arrhythmia of grade > or = 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for female.
  • A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs
  • A patient with peripheral neuropathy of grade 1 by NCI CTC, caused by other factors (e.g. alcohol, diabetes, etc). If the absence of deep tendon reflexes is the only neurologic disorder, this condition does not apply to the exclusion criteria.
  • A patient with organ transplantation requiring immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417143

Contacts
Contact: Yung-Jue Bang, MD, PhD 82-2-2072-2228 bangyj@snu.ac.kr
Contact: Bhumsuk Keam, MD 82-2-2072-7215 bhumsuk@snu.ac.kr

Locations
Korea, Republic of
Department of Internal Medicine, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Bhumsuk Keam, MD    82-2-2072-7215    bhumsuk@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yung-Jue Bang, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01417143     History of Changes
Other Study ID Numbers: H-1012-047-344
Study First Received: August 9, 2011
Last Updated: April 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
dovitinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Adenoid Cystic
Adenocarcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 21, 2014