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

Transitional Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714025
• Other study ID #: UCL-ONCO 08-002
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2008
• Last updated: January 23, 2012
• Start date: November 2008
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma

Intervention

Drug:
• RAD001
RAD001 10mg, daily, PO

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc-UCL	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks	Yes
Secondary	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		8 weeks	Yes