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OpenTrials
Completed

NCT Number: NCT00035243

EPO906 Therapy in Patients With Advanced Kidney Cancer

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre L. Berard, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

epothilone b

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. Objective response rate (ORR)

    Time frame: every 8 weeks

  2. Time to disease progression (TTP)

    Time frame: every 8 weeks

  3. Overall Survival (OS)

    Time frame: every 8 weeks

  4. Safety and tolerability of EPO906

    Time frame: at each visit

  5. Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma

    Time frame: 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

    For biomarker development

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
First posted
May 3, 2002
Registry last updated
Apr 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.