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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase

Completed

Phase 2

Conditions

Transitional Cell Carcinoma

Treatments

Drug: RAD001

Study type

Interventional

Funder types

Other

Identifiers

NCT00714025

UCL-ONCO 08-002

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.