Transitional Cell CarcinomaPhase 2NCT00714025
A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With TCC After Failure of Chemotherapy
A Phase 2 study testing RAD001 in people with Transitional Cell Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Carcinoma
- What is being tested?
- RAD001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2008to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Transitional Cell Carcinoma
- Being tested
- RAD001
- Keywords
- RAD001, TCC, Palliative treatment, advance or metastatic TCC, Failure after Platinum-based chemotherapy
- Medical subject headings
- Carcinoma, Transitional Cell, NOG-Related-Symphalangism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
RAD001 10mg, daily, PO
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | 40 patients with metastatic or locally advanced transitional bladder cancer with failed platinum-based chemotherapy receiving RAD001 10mg daily PO. Receives: Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal H Machiels, MD PhD, Principal investigator, Cliniques Universitaires St Luc-UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714025
- Sponsor's protocol ID
- UCL-ONCO 08-002
- Status last verified
- Jan 2012
- First submitted
- 8 Jul 2008
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00714025
- Acronym / sponsor ID
- UCL-ONCO 08-002
- Conditions
- Transitional Cell Carcinoma
- Keywords
- RAD001, TCC, Palliative treatment, advance or metastatic TCC, Failure after Platinum-based chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: RAD00140 patients with metastatic or locally advanced transitional bladder cancer with failed platinum-based chemotherapy receiving RAD001 10mg daily PO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD001RAD001 10mg, daily, PO | Drug | I |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
Related trials for Transitional Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pascal H Machiels, MD PhD principal investigator
Cliniques Universitaires St Luc-UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD001 in people with Transitional Cell Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.