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

Primary Purpose

Transitional Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
RAD001
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transitional Cell Carcinoma focused on measuring RAD001, TCC, Palliative treatment, advance or metastatic TCC, Failure after Platinum-based chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliniques Universitaires St Luc-UCL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

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

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
July 8, 2008
Last Updated
January 23, 2012
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT00714025
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transitional Cell Carcinoma
Keywords
RAD001, TCC, Palliative treatment, advance or metastatic TCC, Failure after Platinum-based chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
40 patients with metastatic or locally advanced transitional bladder cancer with failed platinum-based chemotherapy receiving RAD001 10mg daily PO.
Intervention Type
Drug
Intervention Name(s)
RAD001
Intervention Description
RAD001 10mg, daily, PO
Primary Outcome Measure Information:
Title
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pascal H Machiels, MD PhD
Organizational Affiliation
Cliniques Universitaires St Luc-UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires St Luc-UCL
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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