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

NCT00641160 | Unknown Phase 1

• 1 other identifier: MT-CL002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonhematologic Malignancies

Keywords

vinorelbine; metronomic dosing; oral administration; nonhematologic malignancies; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs

  Assessed at each subject visit to the study center

Secondary Outcomes (2)

• 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

Drug: vinorelbine tartrate

Cohort 2

EXPERIMENTAL

Drug: vinorelbine tartrate

Cohort 3

EXPERIMENTAL

Drug: vinorelbine tartrate

Interventions

vinorelbine tartrate DRUG

Dose Level #1 PO for at least 7 days

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Metronome Therapeutics: lead

Study Sites (1)

Texas Oncology PA; Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Interventions

Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• George Tidmarsh, MD, PhD

  Metronome Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 24, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 26, 2008

Record last verified: 2008-09

Locations

US (1)