Nausea and Vomiting, Chemotherapy-InducedPhase 1NCT00334646
Cyclophosphamide Drug Interaction Study In Cancer Patients
A Phase 1 study testing Oral GW679769 and IV Cyclophosphamide 500-700mg/m2 in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 5 sites in 3 countries.
Trial summary
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting, Chemotherapy-Induced
- What is being tested?
- Oral GW679769 and IV Cyclophosphamide 500-700mg/m2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Aug 2005to 14 Oct 2009
- 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
- Histologically or cytologically confirmed diagnosis of cancer.
- Undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose of 500 - 700 mg/m2 and a cycle duration of 14-28 days.
- Adequate hematologic, renal and hepatic function.
Who cannot join
- Pregnant or lactating.
- CNS (central nervous system) metastases.
- Active systemic infection or any other poorly controlled medical condition.
- Patients cannot take CYP3A4 inhibitors within 7 days of study treatment or CYP3A4 inducers within 48 days of study treatment.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
GSK Investigational Site
Albuquerque, New Mexico, 87131
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
The Bronx, New York, 10461
About this study
Official title: An Open Label, Repeat Dose, Randomized, Two Period Crossover Study to Investigate the Potential Pharmacokinetic Interactions Between Oral GW679769 and Intravenous Cyclophosphamide in Cancer Patients
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
- Being tested
- Oral GW679769, IV Cyclophosphamide 500-700mg/m2
- Keywords
- cyclophosphamide, CINV, Chemotherapy induced nausea and vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral GW679769Drug
150mg oral, once daily on days 1-3
IV Cyclophosphamide 500-700mg/m2Drug
Also called Oral GW679769
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | cyclophosphamide + dexamethasone + ondansetron Receives: Drug: IV Cyclophosphamide 500-700mg/m2 |
| Arm B | Experimental | cyclophosphamide + dexamethasone + ondansetron + GW679769 Receives: Drug: Oral GW679769 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting.
Measured: throughout the study
Secondary outcomes (1)
Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study start10 Aug 2005
- Primary completion14 Oct 2009
- Study completion14 Oct 2009
Why it stopped: compound terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, Chemotherapy-InducedStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334646
- Sponsor's protocol ID
- NKV103444
- Status last verified
- Nov 2017
- First submitted
- 6 Jun 2006
- Last updated
- 17 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Repeat Dose, Randomized, Two Period Crossover Study to Investigate the Potential Pharmacokinetic Interactions Between Oral GW679769 and Intravenous Cyclophosphamide in Cancer Patients
- ClinicalTrials.gov ID
- NCT00334646
- Acronym / sponsor ID
- NKV103444
- Keywords
- cyclophosphamide, CINV, Chemotherapy induced nausea and vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: compound terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2005 (actual)
- Primary completion
- 14 Oct 2009 (actual)
- Study completion
- 14 Oct 2009 (actual)
- First posted
- 8 Jun 2006 (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.
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: IV Cyclophosphamide 500-700mg/m2cyclophosphamide + dexamethasone + ondansetron |
| Arm B | Experimental | Drug: Oral GW679769cyclophosphamide + dexamethasone + ondansetron + GW679769 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of cancer.
- Undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose of 500 - 700 mg/m2 and a cycle duration of 14-28 days.
- Adequate hematologic, renal and hepatic function.
Key exclusion criteria (4 listed)
- Pregnant or lactating.
- CNS (central nervous system) metastases.
- Active systemic infection or any other poorly controlled medical condition.
- Patients cannot take CYP3A4 inhibitors within 7 days of study treatment or CYP3A4 inducers within 48 days of study treatment.
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 |
|---|---|---|
| Oral GW679769150mg oral, once daily on days 1-3 | Drug | Arm B |
| IV Cyclophosphamide 500-700mg/m2Also: Oral GW679769IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle | Drug | Arm A |
Primary outcome
Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting.
Time frame: throughout the study
1 secondary outcome
Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir
Time frame: throughout the study
Results and safety
The study was stopped early (reason given: compound terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Results for study NKV103444 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral GW679769 and IV Cyclophosphamide 500-700mg/m2 in people with Nausea and Vomiting, Chemotherapy-Induced, run by GlaxoSmithKline at 5 sites in 3 countries.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, New Zealand, Sweden. 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?
The study was stopped early (reason given: compound terminated). 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?
Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting. (time frame: throughout the study). 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 17 Nov 2017.