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Ixempra (Ixabepilone) - Summary

 
 



WARNING: TOXICITY IN HEPATIC IMPAIRMENT

IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death [see Contraindications (4) and Warnings and Precautions ].

 

IXEMPRA SUMMARY

IXEMPRA (ixabepilone) is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones and their analogs. The epothilones are isolated from the myxobacterium Sorangium cellulosum.

IXEMPRA (ixabepilone) is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.

IXEMPRA is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.


See all Ixempra indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ixempra (Ixabepilone)

New insight into alternative treatment options for postmenopausal breast cancer patients using hormone therapy
Source: Breast Cancer News From Medical News Today [2014.07.26]
It's no wonder that breast cancer ranks highest among women's health concerns.

Study identifies genes linked to breast cancer in East Asian women
Source: Breast Cancer News From Medical News Today [2014.07.26]
A new study in East Asian women has identified three genetic changes linked to an increased risk of breast cancer.

Night light exposure could make breast cancer tumors tamoxifen resistant
Source: Breast Cancer News From Medical News Today [2014.07.25]
A study in rats reveals that tamoxifen - a drug typically used to treat breast cancer that has spread - is less effective when subjects are exposed to dim light at night.

Possible target identified for immunotherapy in early-stage breast cancer
Source: Breast Cancer News From Medical News Today [2014.07.23]
Yale Cancer Center researchers used a new molecular analysis tool to accurately detect the level of an important target for immunotherapy in early-stage breast cancers.

Hot Topics 2014: Breast Cancer 2
Source: MedPage Today Oncology/Hematology [2014.07.22]
(MedPage Today) -- In January, we asked breast cancer specialists, "What will be the most important clinical development in breast cancer in 2014?" Our experts revisit their predictions 6 months later.

more news >>

Published Studies Related to Ixempra (Ixabepilone)

Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. [2011.02]
Patients with metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes often have decreased performance status secondary to extensive tumor involvement. Here, we report the pooled analysis of efficacy and safety data from two similarly designed phase III studies to provide a more precise estimate of benefit of ixabepilone plus capecitabine in MBC patients with Karnofsky's performance status (KPS) 70-80...

Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. [2010.07.10]
PURPOSE: We sought to determine whether the combination of ixabepilone plus capecitabine improved overall survival (OS) compared with capecitabine alone in patients with metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes... CONCLUSION: This study confirmed a previous trial demonstrating improved PFS and response for the ixabepilone-capecitabine combination compared with capecitabine alone, although this did not result in improved survival.

Analysis of overall survival from a phase III study of ixabepilone plus capecitabine versus capecitabine in patients with MBC resistant to anthracyclines and taxanes. [2010.07]
Limited proven treatment options exist for patients with metastatic breast cancer (MBC) resistant to anthracycline and taxane treatment.A clinical benefit was also seen in patients in the KPS 70-80 subgroup.

Activity of ixabepilone in oestrogen receptor-negative and oestrogen receptor-progesterone receptor-human epidermal growth factor receptor 2-negative metastatic breast cancer. [2009.11]
Oestrogen receptor (ER)-negative breast cancer, including oestrogen receptor-, progesterone receptor- and human epidermal growth factor receptor 2-negative (ER/PR/HER2-negative) breast cancer, is more aggressive than ER-positive disease. A major limitation in the treatment of ER-negative disease subtypes is the inherent insensitivity to hormonal agents (tamoxifen, aromatase inhibitors) that are widely used in the treatment of breast cancer...

Cost effectiveness of ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. [2009.05.01]
PURPOSE: Using data from a recent randomized trial, we evaluated the cost effectiveness of ixabepilone plus capecitabine versus capecitabine alone in patients with predominantly metastatic breast cancer considered to be taxane-resistant and previously treated with or resistant to an anthracycline... CONCLUSION: Addition of ixabepilone to capecitabine adds approximately $31,000 to overall medical costs and affords approximately 1 additional month of quality-adjusted survival.

more studies >>

Clinical Trials Related to Ixempra (Ixabepilone)

Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer [Recruiting]
In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC.

This trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.

Ixabepilone to Treat Cervical Cancer [Recruiting]
Background:

- Ixabepilone is a member of the class of drugs called epithilones. These drugs interfere

with the ability of cancer cells to replicate.

- Epithilones are similar to taxanes, another class of drugs, which includes the drug

Taxol. Taxol is widely used to treat a variety of cancers.

- Ixabepilone can work in cells that are resistant to Taxol.

Objectives:

- To determine whether ixabepilone is effective for treating cervical cancer.

Eligibility:

- Women 18 years of age or older with cervical cancer.

Design:

- Patients receive ixabepilone intravenously (through a vein) over 60 minutes on the

first 5 days of each 21-day treatment cycle. Their dosage may be adjusted according to how their bodies respond to the drug.

- The number of cycles each woman receives depends on her response to the treatment.

- Patients have CT scans and other tests before starting treatment and then every other

treatment cycle to determine the response of the tumor to ixabepilone.

- Patients who can undergo a tumor biopsy (surgical removal of a sample of tumor tissue)

are asked to have a biopsy done before starting treatment with ixabepilone and again on the fourth or fifth day of treatment. This procedure is optional.

Ixabepilone and Cyclophophamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer [Recruiting]
We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

A Study of Ixabepilone as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer [Recruiting]
The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as measured by overall survival compared to standard chemotherapy (Paclitaxel or Doxorubicin) in women with advanced endometrial cancer that progressed after first line chemotherapy

Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer [Recruiting]
In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior to surgery; after surgery, patients will continue treatment with trastuzumab every three weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the completion of chemotherapy, patients may receive radiation treatment at the discretion of their physician.

more trials >>


Page last updated: 2014-07-26

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