Study of RAD001 in Adenoid Cystic Carcinoma

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Brief Title

Study of RAD001 in Adenoid Cystic Carcinoma

Official Title

Phase II Study of RAD001monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma

Brief Summary

      -  Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on
           mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma.

        -  In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response
           to RAD001 (unpublished data).

        -  So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to
           evaluate the efficacy of RAD001 in this orphan disease.
    

Detailed Description

      Although the histologic appearance of adenoid cystic carcinoma is low grade, management of
      this malignancy is a distinct therapeutic challenge because of its insidious local growth
      pattern, propensity for perineural involvement, tendency for distant metastasis, and
      pronounced ability to recur over a prolonged period.

      In prospectively performed clinical trials, objective responses to any cytotoxic agent or
      regimen are infrequent, whereas stabilization of disease was observed more commonly.

      In adenoid cystic carcinoma, the study focusing on PI3-K/AKT/mTOR pathway is rare.

      According to Younes MN et al's study, adenoid cystic carcinoma cell lines have increased pAkt
      activity when EGF-stimulation is added. And when treated with EGFR/VEGFR TK dual inhibitor,
      the phosphorylated form of Akt decreased despite of total level of Akt is remained unchanged.

      When the investigators consider that the increased pAkt activity is one of possible predictor
      to mTOR inhibitor, the mTOR inhibitor might have an activity in adenoid cystic carcinoma.

      Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR
      inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma.

      In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to
      RAD001 (unpublished data).

      So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to
      evaluate the efficacy of RAD001 in this orphan disease.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

progression free survival rate at 4 months

Secondary Outcome

 the time to progression (TTP)

Condition

Adenoid Cystic Carcinoma

Intervention

RAD001

Study Arms / Comparison Groups

 RAD001
Description:  RAD001 daily po medication

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

July 2008

Completion Date

December 2012

Primary Completion Date

May 2011

Eligibility Criteria

        Inclusion Criteria:

          -  1. Histologically or cytologically confirmed adenoid cystic carcinoma

          -  2. 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.

          -  3. 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)

          -  4. Presence of at least one measurable target lesion for further evaluation according
             to RECIST criteria

          -  5. 18 years or older

          -  6. ECOG performance status 0, 1

          -  7. Previous treatment with chemotherapy, loco-regional therapy (e.g chemoembolization)
             are permitted providing that toxicity has resolved to ≤grade 1 at study entry and that
             last treatment was at least 4 weeks prior to baseline assessment.

          -  8. Adequate organ function

          -  9. A patient with the willingness to comply with the study protocol during the study
             period and capable of complying with it

          -  10. A patient who signed the informed consent prior to the participation of the study
             and who understands that he/she has a right to withdrawal from participation in the
             study at any time without any disadvantages.

        Exclusion Criteria:

          -  1. A patient with no measurable disease

          -  2. 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)

          -  3. A patient with previous active or passive immunotherapy

          -  4. A patient with intestinal obstruction or impending obstruction, recent active upper
             GI bleeding

          -  5. A pregnant or lactating patient

          -  6. 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)

          -  7. A man or woman of childbearing potential who has no willingness to use a
             contraceptive measure during the study

          -  8. 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.

          -  9. 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.

          -  10. 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.

          -  11. Ongoing cardiac arrhythmia of grade ≥2, atrial fibrillation of any grade, or QTc
             interval>450msec for males or >470msec for female.

          -  12. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs

          -  13. 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.

          -  14. A patient with organ transplantation requiring immunosuppressive therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yung-Jue Bang, MD, PhD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01152840

Organization ID

H-0710-050-223


Responsible Party

Sponsor

Study Sponsor

Seoul National University Hospital


Study Sponsor

Yung-Jue Bang, MD, PhD, Principal Investigator, Seoul National University Hospital


Verification Date

June 2010