Overview

This trial is active, not recruiting.

Condition nonhematologic malignancies
Treatments vinorelbine tartrate
Phase phase 1
Sponsor Metronome Therapeutics
Start date March 2008
End date November 2008
Trial size 12 participants
Trial identifier NCT00641160, MT-CL002

Summary

The purpose of this study is to determine the safety of oral administration of vinorelbine once daily for at least 7 days. The study will be conducted in subjects with a non-hematologic malignancy for which there are no currently accepted therapies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vinorelbine tartrate
Dose Level #1 PO for at least 7 days
(Experimental)
vinorelbine tartrate
Dose Level #2 PO for at least 7 days
(Experimental)
vinorelbine tartrate
Dose Level #3 PO for at least 7 days

Primary Outcomes

Measure
Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs
time frame: Assessed at each subject visit to the study center

Secondary Outcomes

Measure
Pharmacokinetics of orally administered vinorelbine
time frame: Samples collected on Study Days 1, 2, and 8
Exploratory analysis of blood markers of biological activity
time frame: Blood samples collected at selected subject visits to the study center

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by Metronome Therapeutics.