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Adenoid Cystic CarcinomaPhase 2ACCRAD001NCT01152840

Study of RAD001 in Adenoid Cystic Carcinoma

A Phase 2 study testing RAD001 in people with Adenoid Cystic Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenoid Cystic Carcinoma
What is being tested?
RAD001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSouth Korea
Study dates
Jul 2008to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: Phase II Study of RAD001monotherapy in Patients With Unresectable 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.
Read the 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.

Being tested
RAD001
Keywords
Adenoid cystic carcinoma, RAD001
Medical subject headings
Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RAD001Drug

    RAD001 10 mg po daily medication

    • Treatments will be continued until any of the following events occur:
    • progression of disease,
    • the subject develops unacceptable toxicity,
    • consent to participate in the study is withdrawn.
Study groups in NCT01152840
Study groupRoleWhat they receive
RAD001ExperimentalRAD001 daily po medication
Receives: Drug: RAD001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival rate at 4 months

    proportion of patients who are alive and progression-free at the time of 4 months of treatment among all patients

    Measured: 10 months

Secondary outcomes (4)

  1. the time to progression (TTP)

    Measured: 10 months

  2. overall survival (OS)

    Measured: 2 years

  3. response rate (RR)

    Measured: 6 months

  4. the metabolic response rate by PET-CT

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2010 (estimated)
  2. Study startJul 2008
  3. Primary completionMay 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01152840
Sponsor's protocol ID
H-0710-050-223
Acronym
ACCRAD001
Status last verified
Jun 2010
First submitted
31 May 2010
Last updated
20 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim DW, Oh DY, Shin SH, Kang JH, Cho BC, Chung JS, Kim H, Park KU, Kwon JH, Han JY, Kim MJ, Bang YJ. A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma. BMC Cancer. 2014 Nov 3;14:795. doi: 10.1186/1471-2407-14-795.

    PubMed 25362970

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RAD001 in people with Adenoid Cystic Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival rate at 4 months (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.

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