Clinical trial · Interventional
Study of RAD001 in Adenoid Cystic Carcinoma
Phase II Study of RAD001monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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 * In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoid Cystic Carcinoma | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001
- description
- RAD001 daily po medication
- interventionNames
- Drug: RAD001
Primary outcomes (1)
- measure
- progression free survival rate at 4 months
- timeFrame
- 10 months
- description
- proportion of patients who are alive and progression-free at the time of 4 months of treatment among all patients
Secondary outcomes (4)
- measure
- the time to progression (TTP)
- timeFrame
- 10 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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. PMID 25362970