A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With TCC After Failure of Chemotherapy

Brief Title

A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With TCC After Failure of Chemotherapy

Official Title

A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma After Failure of Platinum-based Chemotherapy

Brief Summary

      An open-label, single arm, non-randomized, single stage phase II study. 3 phases:Baseline,
      treatment/duration and Follow-up. All patients will be treated with RAD001 10 mg daily dose
      until disease progression or unacceptable toxicity death, or discontinuation from the study,
      for any other reason
    

Detailed Description

      An open-label, single arm, non-randomized, single stage phase II study. Baseline phase:
      Baseline evaluations will be performed within 2 weeks before the first dose study drug.

      Treatment phase/duration of treatment: All patients will be treated with RAD001 10mg PO daily
      dose until disease progression (by RECIST) or unacceptable toxicity death or discontinuation
      from the study for any other reason.

      Follow-up phase: All patients will have a follow-up visit scheduled 28 days after the last
      dose of the study drug to follow for AEs and SAEs that may have occured after discontinuation
      from the study. Any patient who is discontinued from treatment with RAD001 for any reason
      other than disease progression will continue to have tumor assessments until the patient has
      documented disease progression or start of additional anti-tumor therapy. Central radiology
      review and survival data collection will be performed. After discontinuation of RAD001 all
      patients will be followed up for survival until the final OS analysis is performed.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Primary:To evaluate the preliminary efficacy of RAD001 as monotherapy for the treatment of locally advanced or metastatic TCC. Efficacy is defined as the disease control rate at 8 weeks.

Secondary Outcome

 Secondary:To evaluate the response rate, duration of response, progression-free survival and overall survival in this patient population, and further characterize the safety profile of RAD001

Condition

Transitional Cell Carcinoma

Intervention

RAD001

Study Arms / Comparison Groups

 I

Description:  40 patients with metastatic or locally advanced transitional bladder cancer with failed platinum-based chemotherapy receiving RAD001 10mg daily PO.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

November 2008

Completion Date

January 2012

Primary Completion Date

April 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Patients histologically-or cytologically-confirmed locally advanced or metastatic TCC
             not amenable to curative surgery or radiation.

          -  Patients with documented disease progression after first-line platinum based therapy

          -  an interval of more than 4 weeks since last cytotoxic chemotherapy, biological
             therapy, surgery or radiotherapy

          -  patients with at least one measurable lesion as at baseline as per RECIST criteria

          -  ECOG performance status of 0-2

          -  Adequate bone marrow function

          -  Adequate liver function

          -  Adequate renal function

          -  Life expectancy more than 3 months

          -  Women of child-bearing age must have a negative pregnancy test within 72 hours prior
             to the administration of the study treatment start

          -  Signed informed consent prior to beginning protocol specific procedure

          -  Age more than 18 years old

        Exclusion Criteria:

          -  Patients who have received more than 2 systemic treatment for their metastatic disease

          -  Patients who have previously received mTOR inhibitors

          -  Patients with a know hypersensitivity to RAD001 or other rapamycin or to its
             recipients

          -  Patients with brain or leptomeningeal metastases

          -  Patients receiving chronic systemic treatment with corticosteroids or another
             immunosuppressive agent

          -  Patients with a known history of HIV seropositivity

          -  Patients with autoimmune hepatitis

          -  patients with an active, bleeding diathesis

          -  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 more than 5 years

          -  Patients who are using other investigational agents or who had received
             investigational drugs more than 4 weeks prior to study treatment start

          -  Patients unwilling to or unable to comply with the protocol

          -  Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods. If barrier contraceptives
             are being used, these must be continued throughout the trial by both sexes. Oral
             contraceptives are not acceptable.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean-Pascal H Machiels, MD PhD, , 

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT00714025

Organization ID

UCL-ONCO 08-002

Responsible Party

Sponsor

Study Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Sponsor

Jean-Pascal H Machiels, MD PhD, Principal Investigator, Cliniques Universitaires St Luc-UCL

Verification Date

January 2012