Study of RAD001 in Adenoid Cystic Carcinoma

NCT01152840 | Completed Phase 2 DMC

• 1 other identifier: H-0710-050-223
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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• In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data).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

Conditions

Adenoid Cystic Carcinoma

Keywords

Adenoid cystic carcinoma; RAD001

Outcome Measures

Primary Outcomes (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

  10 months

Secondary Outcomes (4)

• the time to progression (TTP)

  10 months

• overall survival (OS)

  2 years

• response rate (RR)

  6 months

• the metabolic response rate by PET-CT

  2 months

Study Arms (1)

RAD001

EXPERIMENTAL

RAD001 daily po medication

Drug: RAD001

Interventions

RAD001 DRUG

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occur: * progression of disease, * the subject develops unacceptable toxicity, * consent to participate in the study is withdrawn.

RAD001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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, 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.
• \. 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/she has a right to withdrawal from participation in the study at any time without any disadvantages.

You may not qualify if:

• \. 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 ≥2, atrial fibrillation of any grade, or QTc interval\>450msec for males or \>470msec for female.
• \. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs
• \. A patient with organ transplantation requiring immunosuppressive therapy

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25362970 DERIVED

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Yung-Jue Bang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Do-Youn Oh, MD,PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: June 29, 2010
• Study Start: July 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 20, 2015

Record last verified: 2010-06

Locations

KR (1)