Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466102
Status:
UNKNOWN
Last Update Posted:
2012-08-30
First Post:
2007-04-25
Brief Title:
Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
Official Title:
RADAR A Randomized Discontinuation Phase II Study to Determine the Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADAR
Brief Summary:
The purpose of this study is to determine wether RAD001 can inhibit growth of tumour cells andor stop the formation and activity of bone degrading osteoclasts
Detailed Description:
RAD001 is an orally bioavailable and well tolerated rapamycin ester analogue which acts by selectively inhibiting mTOR mammalian target of rapamycin mTor is an intracellular protein kinase implicated in the control of cellular proliferation in neoplastic cells Treatment with RAD001 has been shown to inhibit these signalling events and leads to growth retardation of tumour cells In addition RAD001 in vitro stops the formation and activity of osteoclasts Therefore a therapy of advanced breast cancer with progressive bone metastases seems to be reasonable with RAD001
Comparison
All patients receive RAD001 in an 8 week run in phase Patients who show a response after 8 weeks will continue receiving RAD001 All patients with stable disease after the run in phase will be randomised to receive either RAD001 or placebo and will be followed up until progression of disease Patients with progressive disease after the 8 week run in phase will be withdrawn from the trial
Comparison
All patients receive RAD001 in an 8 week run in phase Patients who show a response after 8 weeks will continue receiving RAD001 All patients with stable disease after the run in phase will be randomised to receive either RAD001 or placebo and will be followed up until progression of disease Patients with progressive disease after the 8 week run in phase will be withdrawn from the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None