Know Cancer

or
forgot password

An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell, Neoplasm Metastasis

Thank you

Trial Information

An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy


Inclusion Criteria:



Patients must fulfill all of the following criteria to be eligible for study
participation:

- Age ≥ 18 years;

- Histologically confirmed Renal Cell Carcinoma (RCC);

- Metastatic disease, with measurable lesions according to the Response Evaluation
Criteria in Solid Tumors (RECIST);

- Failure of prior cytokine therapy;

- Documented progressive disease;

Exclusion Criteria:

Patients are ineligible for entry if any of the following criteria are met:

- Significant cardiac disease including congestive heart failure, history of myocardial
infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina

- History of serious ventricular arrhythmia

- Corrected QT interval (QTc) ≥ 500 msec

- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;

- Previous extensive radiotherapy involving ≥ 30% of bone marrow

- Coexistent second malignancy or history of prior malignancy within previous 5 years

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).

Outcome Time Frame:

Up to 6 months

Safety Issue:

No

Principal Investigator

William McCulloch, MB, FRCP

Investigator Role:

Study Director

Investigator Affiliation:

Gloucester Pharmaceuticals Inc.

Authority:

United States: Food and Drug Administration

Study ID:

FJ-228-0001

NCT ID:

NCT00106613

Start Date:

May 2003

Completion Date:

August 2004

Related Keywords:

  • Carcinoma, Renal Cell
  • Neoplasm Metastasis
  • Renal Cell Carcinoma
  • Metastatic Cancer
  • Metastatic Renal Cell Carcinoma
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis

Name

Location

City of Hope National Medical CenterLos Angeles, California  91010
Seattle Cancer Care AllianceSeattle, Washington  98109
University of ChicagoChicago, Illinois  60637