Trial intelligence / Profile preview

Carboxyamidotriazole in Advanced Renal Cell Carcinoma

NCT00005045Phase 2

Key facts

Status
Completed
Start
Mar 2000
Countries
3
Sponsor
Eastern Cooperative Oncology Group
Modality
Small Molecules
Conditions
renal cell carcinoma (RCC)
01

Overview

Phase 2, open-label, single-arm trial of carboxyamidotriazole in renal cell carcinoma (RCC), sponsored by Eastern Cooperative Oncology Group. Primary endpoint: Progression-Free Survival Rate at 6 months. Started Mar 2000; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Carboxyamidotriazole

    Patients receive oral carboxyamidotriazole daily.

03

Who it enrols

Patients with histologically proven advanced renal cell carcinoma who are refractory to immunotherapy (1-2 prior biologic regimens), have measurable progressive disease, ECOG 0-2, and adequate organ function. Patients with brain metastases or prior chemotherapy are excluded.

04

Endpoints

Primary

  • Progression-Free Survival Rate

Secondary

  • Progression-Free Survival Rate

  • Objective Response Rate

  • Toxic Effect

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