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
Recruitment status was Active, not recruiting
Sponsor:
Metronome Therapeutics
Information provided by:
Metronome Therapeutics
ClinicalTrials.gov Identifier:
NCT00641160
First received: March 19, 2008
Last updated: September 24, 2008
Last verified: September 2008
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Purpose
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641160
Locations
| United States, Texas | |
| Texas Oncology PA; Sammons Cancer Center | |
| Dallas, Texas, United States, 75246 | |
Sponsors and Collaborators
Metronome Therapeutics
Investigators
| Study Director: | George Tidmarsh, MD, PhD | Metronome Therapeutics |
More Information
No publications provided
| Responsible Party: | George Tidmarsh, MD, PhD, Metronome Therapeutics |
| ClinicalTrials.gov 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:
|
vinorelbine metronomic dosing oral administration nonhematologic malignancies pharmacokinetics |
Additional relevant MeSH terms:
|
Neoplasms Vinorelbine Vinblastine Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013