Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies

Sponsor

Metronome Therapeutics (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00641160

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nonhematologic Malignancies	Drug: vinorelbine tartrate Drug: vinorelbine tartrate Drug: vinorelbine tartrate	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2008

Anticipated Primary Completion Date :

Nov 1, 2008

Anticipated Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1	Drug: vinorelbine tartrate Dose Level #1 PO for at least 7 days
Experimental: Cohort 2	Drug: vinorelbine tartrate Dose Level #2 PO for at least 7 days
Experimental: Cohort 3	Drug: vinorelbine tartrate Dose Level #3 PO for at least 7 days

Arm

Intervention/Treatment

Experimental: Cohort 1

Drug: vinorelbine tartrate

Dose Level #1 PO for at least 7 days

Experimental: Cohort 2

Drug: vinorelbine tartrate

Dose Level #2 PO for at least 7 days

Experimental: Cohort 3

Drug: vinorelbine tartrate

Dose Level #3 PO for at least 7 days

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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