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

NCT ID: NCT00641160

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nonhematologic Malignancies

Keywords

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vinorelbine metronomic dosing oral administration nonhematologic malignancies pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

vinorelbine tartrate

Intervention Type DRUG

Dose Level #1 PO for at least 7 days

Cohort 2

Group Type EXPERIMENTAL

vinorelbine tartrate

Intervention Type DRUG

Dose Level #2 PO for at least 7 days

Cohort 3

Group Type EXPERIMENTAL

vinorelbine tartrate

Intervention Type DRUG

Dose Level #3 PO for at least 7 days

Interventions

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vinorelbine tartrate

Dose Level #1 PO for at least 7 days

Intervention Type DRUG

vinorelbine tartrate

Dose Level #2 PO for at least 7 days

Intervention Type DRUG

vinorelbine tartrate

Dose Level #3 PO for at least 7 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metronome Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Metronome Therapeutics

Principal Investigators

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George Tidmarsh, MD, PhD

Role: STUDY_DIRECTOR

Metronome Therapeutics

Locations

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Texas Oncology PA; Sammons Cancer Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MT-CL002

Identifier Type: -

Identifier Source: org_study_id