Clinical trial NCT00641160: Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Nonhematologic Malignancies
Keywords: vinorelbine
metronomic dosing
oral administration
nonhematologic malignancies
pharmacokinetics
Lead sponsor: Metronome Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs
timeFrame: Assessed at each subject visit to the study center
Secondary outcomes:
measure: Pharmacokinetics of orally administered vinorelbine
timeFrame: Samples collected on Study Days 1, 2, and 8
measure: Exploratory analysis of blood markers of biological activity
timeFrame: Blood samples collected at selected subject visits to the study center
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Oncology PA; Sammons Cancer Center
state: Texas
Study officials:
affiliation: Metronome Therapeutics
name: George Tidmarsh, MD, PhD
role: STUDY_DIRECTOR
References: