Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma

NCT01525719 | Unknown Phase 2

• 1 other identifier: R-53326
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether everolimus is effective in the treatment of patients with advance cholangiocarcinoma.

Conditions

Cholangiocarcinoma

Keywords

cholangiocarcinoma; RAD001; everolimus

Outcome Measures

Primary Outcomes (1)

• progression free survival in cholangiocarcinoma patients whom treated with everolimus

  One year

Secondary Outcomes (1)

• overall survival rate

  Two years

Study Arms (1)

RAD001

EXPERIMENTAL

Drug: Everolimus

Interventions

Everolimus DRUG

10 mg everolimus

Also known as: RAD001

RAD001

Eligibility Criteria

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

You may qualify if:

• Histologic confirmed diagnosis of cholangiocarcinoma.
• Patients must present with disease not amenable to curative surgery.
• ECOG performance status of \< 2
• Patients with at least one measurable lesion at baseline as per the RECIST criteria.
• The following laboratory parameters at screening (visit 1):
• WBC are equal to or more than 3,000/uL. Platelet are equal to or more than 100,000/uL Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN. Patients with known liver metastases: AST and ALT ≤ 5 x ULN Total Bilirubin \< 2 mg/dl\* (after drainage) Serum creatinine equal to or less than 2.0 x upper normal limit
• Life expectancy equal to or more than 12 weeks.
• Ability to understand and willingness to sign a written informed consent and to be able to follow the visit schedule.
• Female patients at child-bearing age must have negative pregnancy test.
• Patients refuse to have treatment with Chemotherapy or Radiation.

You may not qualify if:

• Patients within 2 weeks post-minor surgery, 4 weeks post-major surgery to avoid wound healing complications. Percutaneous biopsies require no waiting time prior to study entry.
• Patients with a recent history of hemoptysis, ≥ 0.5 teaspoon of red blood.
• Patients who have received prior systemic treatment for their metastatic cholangiocarcinoma.
• Presence of clinically relevant ascites or liver failure.
• Patients with extensive symptomatic fibrosis of the lungs.
• Patients with a known hypersensitivity to RAD001 (everolimus).
• Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus, deforolimus).
• History or clinical evidence of central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery±radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
• Are asymptomatic Have had no evidence of active CNS metastases for ≥ 6 months prior to enrollment and Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC)
• Clinically significant gastrointestinal abnormalities including, but not limited to:
• Malabsorption syndrome Major resection of the stomach or small bowel that could affect the absorption of RAD001 Active peptic ulcer disease Inflammatory bowel disease Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning of study treatment;
• Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. Inhaled and topical steroids are acceptable
• Patients with a known history of human immunodeficiency virus seropositivity
• Patients with autoimmune hepatitis
• Patients with an active, bleeding diathesis. Patients may use coumadin or heparin preparations.

Sponsors & Collaborators

• Ratchavithi Hospital: lead

MeSH Terms

Conditions

Cholangiocarcinoma

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

• Kawin Leelawat, MD, PhD

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Surgery

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 3, 2012

Record last verified: 2012-01