Viewing Study NCT00558545



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Study NCT ID: NCT00558545
Status: TERMINATED
Last Update Posted: 2009-12-02
First Post: 2007-11-13

Brief Title: A Phase 1-2 XIAP Antisense AEG35156 With Weekly Paclitaxel in Patients With Advanced Breast Cancer
Sponsor: Aegera Therapeutics
Organization: Aegera Therapeutics

Study Overview

Official Title: A Phase 1-2 Multicenter Open-Label Study of the X-Linked Inhibitor of Apoptosis XIAP Antisense AEG35156 Given in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer
Status: TERMINATED
Status Verified Date: 2009-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Avastin approved for first-in-line treatment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is an open-label multicenter phase 1-2 study Following determination of the recommended AEG35156 dose in combination with weekly paclitaxel in the initial Phase 1 part of this study additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination in advanced breast cancer
Detailed Description: Breast cancer is the most common cancer in women in the United States the second most common cause of cancer death and the main cause of death in women ages 45 to 55 In 2006 212920 American women will be diagnosed with breast cancer and 40970 will die from this disease1 Fewer than 10 percent of women present with metastatic disease at the time of diagnosis However the majority of women who relapse after initial definitive therapy for early stage or locally advanced disease will do so with disseminated metastatic disease rather than an isolated local recurrence Treatment for metastatic disease is palliative in intent and will usually involve hormone therapy andor chemotherapy with or without trastuzumab Active chemotherapy agents include anthracyclines taxanes vinorelbine alkylating agents and antimetabolites Taxanes have become the cornerstone of first-line treatment for metastatic breast cancer Weekly doses of paclitaxel can be administered continuously for several weeks with a remarkable lack of myelosuppression 2 Weekly paclitaxel 80 mgm2 was directly compared to every three-week therapy 175 mgm2 in 585 women with metastatic breast cancer Weekly therapy was associated with a significantly higher response rate 40 versus 28 percent and longer TTP nine versus five months but similar overall survival and worse neurotoxicity 3 Since patients with metastatic breast cancer are unlikely to be cured of their disease 4 they should be considered candidates for a clinical 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