Know Cancer

or
forgot password

A Phase 1 Study of the Safety, Pharmacokinetics, and Biological Activity of Metronomic Dosing With Orally Administered Vinorelbine Tablets in Subjects With Non-Hematologic Malignancies For Which There Are No Currently Accepted Therapies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Nonhematologic Malignancies

Thank you

Trial Information

A Phase 1 Study of the Safety, Pharmacokinetics, and Biological Activity of Metronomic Dosing With Orally Administered Vinorelbine Tablets in Subjects With Non-Hematologic Malignancies For Which There Are No Currently Accepted Therapies


Inclusion Criteria:



- capable of understanding study requirements and able to provide Informed Consent

- diagnosed with a non-hematologic malignancy for which there are no currently accepted
therapies

- life expectancy at least 3 months

- agreement to use medically acceptable contraception throughout the study

- willing and able to comply with the protocol requirements

Exclusion Criteria:

- currently receiving systemic treatment for malignancy

- not yet recovered from the toxicity of prior therapies

- platelet count < 100,000 cells/mm3 within 7 days prior to study entry

- ANC < 1500 cells/mm3 within 7 days prior to study entry

- hemoglobin < 8.5 g/dL within 7 days prior to study entry

- AST and/or ALT > 2.5 X ULN within 7 days prior to study entry

- total bilirubin > 1.5 X ULN within 7 days prior to study entry

- creatinine clearance < 60 mL/min (Cockroft-Gault formula) within 7 days prior to
study entry

- receipt of any investigational therapy within 3 weeks prior to study entry

- known history of HIV, HBV, and/or HCV infection

- clinically relevant active infection or serious co-morbid medical condition at study
entry

- major surgery within 4 weeks prior to study entry

- other malignancy within 3 year prior to study entry

- pregnant or breast-feeding

- presence of a concomitant disease or condition which, in the opinion of the
Investigator, could interfere with the conduct of the study or could put the subject
at unacceptable risk

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs

Outcome Time Frame:

Assessed at each subject visit to the study center

Safety Issue:

No

Principal Investigator

George Tidmarsh, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Metronome Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

MT-CL002

NCT ID:

NCT00641160

Start Date:

March 2008

Completion Date:

November 2008

Related Keywords:

  • Nonhematologic Malignancies
  • vinorelbine
  • metronomic dosing
  • oral administration
  • nonhematologic malignancies
  • pharmacokinetics
  • Neoplasms

Name

Location

Texas Oncology PA; Sammons Cancer CenterDallas, Texas  75246