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

Metronome Therapeutics

Status and phase: Unknown; Phase 1

Conditions: Nonhematologic Malignancies

Treatments: Drug: vinorelbine tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641160

MT-CL002

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Cohort 1

Experimental group

Treatment:

Drug: vinorelbine tartrate

Drug: vinorelbine tartrate

Drug: vinorelbine tartrate

Cohort 2

Experimental group

Treatment:

Drug: vinorelbine tartrate

Drug: vinorelbine tartrate

Drug: vinorelbine tartrate

Cohort 3

Experimental group

Treatment:

Drug: vinorelbine tartrate

Drug: vinorelbine tartrate

Drug: vinorelbine tartrate