EPO906 Therapy in Patients With Advanced Kidney Cancer

Kidney Neoplasms Clinical Trial

Official title:

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035243
• Other study ID #: CEPO906A2207
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: April 16, 2012
• Start date: April 2002

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

Other known NCT identifiers

• NCT00041002

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

The following patients may be eligible for this study:

• Histologically or cytologically documented evidence of epithelial renal cell carcinoma with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)

• Patients must have had a prior nephrectomy

• Must have a life expectancy of greater than three (3) months

• Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or relapsed less than one year after such treatment may be eligible.

Exclusion Criteria:

The following patients are not eligible for this study:

• Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?) or relapsed more than one year after receiving such treatment are not eligible

• Patients who have had any prior chemotherapy (including a combination therapy)

• Patients with symptomatic CNS metastases or leptomeningeal involvement

• Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1

• Patients with 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 3 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ

• Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae

• HIV+ patients

• Pregnant or lactating females.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Drug:
• epothilone b
EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.

Locations

Country	Name	City	State
France	Centre L. Berard	Lyon
France	Institut Gustave Roussy	Villejuif
United States	University of Maryland	Baltimore	Maryland
United States	Our Lady Of Mercy Medical Center	Bronx	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Wayne State University Karmanos Cancer Center	Detroit	Michigan
United States	UCLA Medical Center	Los Angeles	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)		every 8 weeks	No
Secondary	Objective response rate (ORR)		every 8 weeks	No
Secondary	Time to disease progression (TTP)		every 8 weeks	No
Secondary	Overall Survival (OS)		every 8 weeks	No
Secondary	Safety and tolerability of EPO906		at each visit	Yes
Secondary	Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma	For biomarker development	prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment	No