EPO906 Therapy in Patients With Advanced Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00035126
• Date of registration: 02/05/2002
• Primary sponsor: Novartis Pharmaceuticals
• Public title: EPO906 Therapy in Patients With Advanced Breast Cancer
• Scientific title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer
• Date of first enrolment: January 2002
• Target sample size: 46
• Recruitment status: Suspended
• URL: http://clinicaltrials.gov/show/NCT00035126
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

The following patients may be eligible for this study:

- Histologically or cytologically documented evidence of disease with at least one
measurable lesion;

- Life expectancy of greater than three (3) months;

- Patients who have had only one prior therapy for metastatic disease;

- Patients who have received prior treatment with hormonal agents or who have had prior
treatment regimens of radiotherapy in addition to one or no previous chemotherapy
regimens are eligible;

- Patients who have had no prior therapy for metastatic disease, but who have received
a taxane and an anthracycline (single or combination therapy) as adjuvant treatment,
are eligible. For patients who have had previous radiation therapy to the target
lesion(s), the lesion(s) must since have demonstrated progression.

Exclusion Criteria:

The following patients are not eligible for this study:

- Bone-only disease;

- Symptomatic pleural effusions;

- Symptomatic CNS metastases or leptomeningeal involvement;

- Any peripheral neuropathy or unresolved diarrhea greater than Grade 1;

- Severe cardiac insufficiency;

- Patients taking Coumadin or other warfarin-containing agents with the exception of
low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports;

- History of another malignancy within 5 years prior to study entry except curatively
treated non-melanoma ckin cancer or cervical cancer in situ;

- Active or suspected acute or chronic uncontrolled infection including abcesses or
fistulae;

- HIV+ patients;

- Pregnant or lactating females;

- Patients who have had radiation, chemotherapy, or hormonal therapy within the last
four (4) weeks excluding palliative radiotherapy to isolated peripheral bone
metastases not being used as markers for efficacy;

- Patients taking Herceptin less than three (3) weeks prior to study start.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: epothilone b

Primary Outcome(s)

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) [Time Frame: Every 8 weeks]

Secondary Outcome(s)

Duration of overall response [Time Frame: every 8 weeks as clinically needed]

Overall survival [Time Frame: date of death or last date patient was known to be alive]

pharmacokinectics of study drug [Time Frame: every 8 weeks]

Safety of study drug [Time Frame: weekly for the first 8 weeks, then every other week]

Time to progression [Time Frame: until disease progression, death or date of last follow-up]

Secondary ID(s)

CEPO906A2205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors