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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00714025
First received: July 8, 2008
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Transitional Cell Carcinoma
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: January 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
40 patients with metastatic or locally advanced transitional bladder cancer with failed platinum-based chemotherapy receiving RAD001 10mg daily PO.
Drug: RAD001
RAD001 10mg, daily, PO

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714025

Locations
Belgium
Cliniques Universitaires St Luc-UCL
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Jean-Pascal H Machiels, MD PhD Cliniques Universitaires St Luc-UCL
  More Information

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00714025     History of Changes
Other Study ID Numbers: UCL-ONCO 08-002
Study First Received: July 8, 2008
Last Updated: January 23, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
RAD001
TCC
Palliative treatment
advance or metastatic TCC
Failure after Platinum-based chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014