Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003752
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
1999-11-01
Brief Title:
Bexarotene in Treating Patients With Metastatic Breast Cancer
Sponsor:
Ligand Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Phase II Evaluation of Targretin Bexarotene Capsules in Patients With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase II trial to study the effectiveness of bexarotene in treating patients who have metastatic breast cancer
PURPOSE Randomized phase II trial to study the effectiveness of bexarotene in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of oral bexarotene LGD1069 at two different dose levels in patients with advanced breast cancer II Assess the safety and tolerability of this treatment regimen in this patient population III Evaluate the efficacy of oral bexarotene in terms of induction of differentiation and decreased aberrant cell proliferation in these patients
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to prior therapy for metastatic disease Patients are randomized to one of two dose levels All patients receive oral bexarotene once daily Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed every week for the first month at weeks 6 and 8 then monthly thereafter
PROJECTED ACCRUAL A total of 84-180 patients will be accrued for this study
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to prior therapy for metastatic disease Patients are randomized to one of two dose levels All patients receive oral bexarotene once daily Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed every week for the first month at weeks 6 and 8 then monthly thereafter
PROJECTED ACCRUAL A total of 84-180 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-9808M00110 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066873 | REGISTRY | None | None |
| MSKCC-99008 | None | None | None |