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

Phase 2
18 Years
Open (Enrolling)
Adenoid Cystic Carcinoma

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Trial Information

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

open, uncontrolled, multi-center, phase II study

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Description:

To determine 4month progression-free survival of TKI258 (Dovitinib) when administered as monotherapy in patients with unresectable adenoid cystic carcinoma

Outcome Time Frame:

4 month

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Adenoid Cystic Carcinoma
  • dovitinib
  • Carcinoma
  • Carcinoma, Adenoid Cystic