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

NCT00714025 | Completed Phase 2

• 1 other identifier: UCL-ONCO 08-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Transitional Cell Carcinoma

Keywords

RAD001; TCC; Palliative treatment; advance or metastatic TCC; Failure after Platinum-based chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

I

EXPERIMENTAL

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

Drug: RAD001

Interventions

RAD001 DRUG

RAD001 10mg, daily, PO

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires St Luc-UCL

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; NOG-Related-Symphalangism Spectrum Disorder

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Jean-Pascal H Machiels, MD PhD

  Cliniques Universitaires St Luc-UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: January 1, 2012
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

BE (1)