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

September 24, 2008 updated by: Metronome Therapeutics

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology PA; Sammons Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed at each subject visit to the study center

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of orally administered vinorelbine
Time Frame: Samples collected on Study Days 1, 2, and 8
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
Blood samples collected at selected subject visits to the study center

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metronome Therapeutics

Investigators

  • Study Director: George Tidmarsh, MD, PhD, Metronome Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

November 1, 2008

Study Completion (ANTICIPATED)

November 1, 2008

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (ESTIMATE)

March 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2008

Last Update Submitted That Met QC Criteria

September 24, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-CL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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