- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01525719
Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma (CRAD001T)
A Phase II Single Arm Study to Evaluate the Safety and Efficacy of RAD001 as Monotherapy in Treatment naïve Advanced Cholangiocarcinoma
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- Patients who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of uterine.
- Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods.
- Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
- Patients unwilling or unable to comply with the protocol.
- Patient who will have got benefit from Radiation or Chemotherapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: RAD001
|
10 mg everolimus
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival in cholangiocarcinoma patients whom treated with everolimus
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival rate
Time Frame: Two years
|
Overall survival is defined as the time from dater of start of treatment to date of death due to any cause.
|
Two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kawin Leelawat, MD, PhD, Rajavithi Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-53326
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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