Dovitinib in Adenoid Cystic Carcinoma

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Brief Title

Dovitinib in Adenoid Cystic Carcinoma

Official Title

Phase II Study of TKI258 (Dovitinib) Monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma

Brief Summary

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

Detailed Description

      open, uncontrolled, multi-center, phase II study
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

progression free survival

Secondary Outcome

 overall survival

Condition

Adenoid Cystic Carcinoma

Intervention

TKI258 (Dovitinib):

Study Arms / Comparison Groups

 TKI258 (Dovitinib)
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

September 2011

Completion Date

November 2014

Primary Completion Date

December 2013

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01417143

Organization ID

H-1012-047-344


Responsible Party

Principal Investigator

Study Sponsor

Seoul National University Hospital


Study Sponsor

, , 


Verification Date

November 2014