Trial Information
Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
Inclusion Criteria
- Patients with histological evidence of malignancy that has become refractory to
standard therapy, or for whom effective standard therapy does not exist.
- Patients with an estimated life-expectancy of at least 3 months
- Patients with a Karnofsky Performance Score of at least 60%
- Patients with no history of congestive heart failure (CHF), and normal ejection
fraction by echocardiography
- Patients with adequate renal and hepatic function
- Patients with adequate bone marrow status
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Richard H Wheeler, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Huntsman Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
KN-001-01
NCT ID:
NCT00031031
Start Date:
June 2001
Completion Date:
November 2002
Related Keywords:
- Solid Tumors Refractory To Standard Therapy
- Neoplasms
- MTD
- Safety
- Pharmacokinetics
- Efficacy
- Neoplasms
Name | Location |
Huntsman Cancer Institue |
Salt Lake City, Utah 84112 |