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Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors Refractory To Standard Therapy, Neoplasms

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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 InstitueSalt Lake City, Utah  84112