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

Nonhematologic Malignancies Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00641160
• Other study ID #: MT-CL002
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 19, 2008
• Last updated: September 24, 2008
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: September 2008
• Source: Metronome Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Nonhematologic Malignancies

Intervention

Drug:
• vinorelbine tartrate
Dose Level #1 PO for at least 7 days
• vinorelbine tartrate
Dose Level #2 PO for at least 7 days
• vinorelbine tartrate
Dose Level #3 PO for at least 7 days

Locations

Country	Name	City	State
United States	Texas Oncology PA; Sammons Cancer Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Metronome Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs		Assessed at each subject visit to the study center	No
Secondary	Pharmacokinetics of orally administered vinorelbine		Samples collected on Study Days 1, 2, and 8	No
Secondary	Exploratory analysis of blood markers of biological activity		Blood samples collected at selected subject visits to the study center	No