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CholangiocarcinomaPhase 2CRAD001TNCT01525719

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

A Phase 2 study testing Everolimus in people with Cholangiocarcinoma, run by Ratchavithi Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2012to Jun 2014
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

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.

About this study

Official title: A Phase II Single Arm Study to Evaluate the Safety and Efficacy of RAD001 as Monotherapy in Treatment naïve Advanced Cholangiocarcinoma

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

Read the detailed description

Cholangiocarcinoma is one of the most common cause of cancer death in Thailand. Patients with cholangiocarcinoma are often diagnosed at advanced stage. Palliative therapeutic approaches consisting of percutaneous and endoscopic biliary drainage have usually been used for these patients, since there is no effective chemotherapeutic treatment for this type of cancer. Activation of the phosphoinositide-3-kinase (PI3K)/Akt/mTOR signaling pathway is frequently found in cholangiocarcinoma cells. It has been suggested to be a key step leading to the progression of cholangiocarcinoma. In this study, the investigators hypothesize that inhibition of mTOR may be useful in treating cholangiocarcinoma.

Being tested
Everolimus
Keywords
cholangiocarcinoma, RAD001, everolimus
Medical subject headings
Cholangiocarcinoma

What participants receive

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

Study groups in NCT01525719
Study groupRoleWhat they receive
RAD001ExperimentalNot described
Receives: Drug: Everolimus

What is being measured

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

  1. progression free survival in cholangiocarcinoma patients whom treated with everolimus

    Measured: One year

Secondary outcomes (1)

  1. overall survival rate

    Overall survival is defined as the time from dater of start of treatment to date of death due to any cause.

    Measured: Two years

Timeline

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

  1. First posted3 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2013 (estimated)
  4. Study completionJun 2014 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01525719
Sponsor's protocol ID
R-53326
Acronym
CRAD001T
Status last verified
Jan 2012
First submitted
31 Jan 2012
Last updated
3 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus in people with Cholangiocarcinoma, run by Ratchavithi Hospital.

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 21 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: status not confirmed, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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 in cholangiocarcinoma patients whom treated with everolimus (time frame: One year). 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 NCT01525719.

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 3 Feb 2012.

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