Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Metronome Therapeutics.
Recruitment status was  Active, not recruiting
Information provided by:
Metronome Therapeutics Identifier:
First received: March 19, 2008
Last updated: September 24, 2008
Last verified: September 2008

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.

Condition Intervention Phase
Nonhematologic Malignancies
Drug: vinorelbine tartrate
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Metronome Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of orally administered vinorelbine [ Time Frame: Samples collected on Study Days 1, 2, and 8 ] [ Designated as safety issue: No ]
  • Exploratory analysis of blood markers of biological activity [ Time Frame: Blood samples collected at selected subject visits to the study center ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: March 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: vinorelbine tartrate
Dose Level #1 PO for at least 7 days
Experimental: Cohort 2 Drug: vinorelbine tartrate
Dose Level #2 PO for at least 7 days
Experimental: Cohort 3 Drug: vinorelbine tartrate
Dose Level #3 PO for at least 7 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00641160

United States, Texas
Texas Oncology PA; Sammons Cancer Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Metronome Therapeutics
Study Director: George Tidmarsh, MD, PhD Metronome Therapeutics
  More Information

No publications provided

Responsible Party: George Tidmarsh, MD, PhD, Metronome Therapeutics Identifier: NCT00641160     History of Changes
Other Study ID Numbers: MT-CL002
Study First Received: March 19, 2008
Last Updated: September 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Metronome Therapeutics:
metronomic dosing
oral administration
nonhematologic malignancies

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on November 23, 2014