Nonhematologic MalignanciesPhase 1NCT00641160
Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies
A Phase 1 study testing vinorelbine tartrate in people with Nonhematologic Malignancies, run by Metronome Therapeutics at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonhematologic Malignancies
- What is being tested?
- vinorelbine tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Oncology PA; Sammons Cancer Center
Dallas, Texas, 75246
About this study
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
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
- Being tested
- vinorelbine tartrate
- Keywords
- vinorelbine, metronomic dosing, oral administration, nonhematologic malignancies, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinorelbine tartrateDrug
Dose Level #1 PO for at least 7 days
vinorelbine tartrateDrug
Dose Level #2 PO for at least 7 days
vinorelbine tartrateDrug
Dose Level #3 PO for at least 7 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: vinorelbine tartrate |
| Cohort 2 | Experimental | Not described Receives: Drug: vinorelbine tartrate |
| Cohort 3 | Experimental | Not described Receives: Drug: vinorelbine tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs
Measured: Assessed at each subject visit to the study center
Secondary outcomes (2)
Pharmacokinetics of orally administered vinorelbine
Measured: Samples collected on Study Days 1, 2, and 8
Exploratory analysis of blood markers of biological activity
Measured: Blood samples collected at selected subject visits to the study center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonhematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metronome Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- George Tidmarsh, MD, PhD, Study director, Metronome Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641160
- Sponsor's protocol ID
- MT-CL002
- Status last verified
- Sep 2008
- First submitted
- 19 Mar 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00641160
- Acronym / sponsor ID
- MT-CL002
- Conditions
- Nonhematologic Malignancies
- Keywords
- vinorelbine, metronomic dosing, oral administration, nonhematologic malignancies, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Metronome TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: vinorelbine tartrate |
| Cohort 2 | Experimental | Drug: vinorelbine tartrate |
| Cohort 3 | Experimental | Drug: vinorelbine tartrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vinorelbine tartrateDose Level #1 PO for at least 7 days | Drug | Cohort 1 |
| vinorelbine tartrateDose Level #2 PO for at least 7 days | Drug | Cohort 2 |
| vinorelbine tartrateDose Level #3 PO for at least 7 days | Drug | Cohort 3 |
Primary outcome
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
2 secondary outcomes
Pharmacokinetics of orally administered vinorelbine
Time frame: Samples collected on Study Days 1, 2, and 8
Exploratory analysis of blood markers of biological activity
Time frame: Blood samples collected at selected subject visits to the study center
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Tidmarsh, MD, PhD study director
Metronome Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vinorelbine tartrate in people with Nonhematologic Malignancies, run by Metronome Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2008.