Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00389922
Lapatinib and Vinorelbine in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing lapatinib ditosylate, vinorelbine ditartrate and comparative genomic hybridization in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of California, Davis at 4 sites in United States.
Trial summary
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- lapatinib ditosylate, vinorelbine ditartrate and comparative genomic hybridization
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2005to Dec 2011
- 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
- Cytologically or histologically proven advanced solid tumors for which there is no known standard therapy available or are not eligible for standard therapy because of their performance status, or have progressed after no more than 2 prior chemotherapy regimens for metastatic disease.
- Measurable or evaluable disease. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy.
- 18 years of age or older.
- Zubrod performance status of 0-2.
- Estimated survival of at least 3 months.
- Any prior chemotherapy must have been completed at least 4 weeks prior to start of this protocol and all side effects (except alopecia) resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy. For prior mitomycin chemotherapy a 6-week interval is required. Patients must have completed prior trastuzumab at least 4 weeks prior to start of protocol therapy.
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- Adequate renal function
- Adequate liver function
- Pretreatment granulocyte count of >1500/mm3 and platelet count of >100 000/mm3.
- Cardiac ejection fraction within the institutional range of normal as measured by 2-D echocardiogram or MUGA scan.
- Asymptomatic treated brain metastasis may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks.
- All patients must give informed consent.
- Able to take and retain oral medication.
- Patients of reproductive potential must agree to use an effective contraceptive method
Who cannot join
- Patients may not have previously received lapatinib, vinorelbine or any other EGFR-1 targeted agent. Prior trastuzumab is allowed.
- Females cannot be pregnant or breastfeeding
- Symptomatic brain metastasis or still requiring steroids and anticonvulsants may not participate.
- Pre-existing neuropathy > grade 2 may not participate.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, will be excluded.
- History of other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications.
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- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or prior surgical procedures affecting absorption.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib.
- Patients requiring oral anticoagulants are eligible provided there is appropriate close INR monitoring is in place. If medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with lapatinib is not expected.
- Adherence to the requirements for concomitant medications classified as CYP3A4 inducers or inhibitors, or gastric pH modifiers
Trial locations and contacts
4 sites in 1 country.
United States4 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
University of California Davis Cancer Center
Sacramento, California, 95817
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: Phase I Study of Two Different Schedules of Lapatinib (GW572016) in Combination With Vinorelbine in Advanced Solid Tumors
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with vinorelbine in treating patients with advanced solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety and feasibility of 2 different schedules of lapatinib ditosylate when administered with vinorelbine ditartrate in patients with advanced solid tumors.
Secondary
- Determine the maximum tolerated dose (MTD) of each of these regimens in these patients.
- Determine, preliminarily, the efficacy of these regimens in these patients.
- Examine tissue and blood specimens from these patients to investigate potential predictors of response.
- Determine the pharmacokinetics of lapatinib ditosylate and vinorelbine ditartrate in patients treated at the MTD.
OUTLINE: This is a phase I study comprising 2 separate, sequential dose-escalation studies of lapatinib ditosylate. Patients are assigned to 1 of 2 treatment groups.
- Group A (daily dosing): Patients receive oral lapatinib ditosylate once daily on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15.
Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A.
- Pharmacokinetics (PK) cohort*: Patients in the PK cohort receive vinorelbine ditartrate IV as in group A and oral lapatinib ditosylate once daily at the MTD on days 3-28 (course 1 only) and on days 1-28 in all subsequent courses. Patients undergo PK sampling during course 1.
NOTE: *Accrual to group B and to the PK cohort of group A may occur simultaneously.
- Group B (intermittent dosing): Patients receive oral lapatinib ditosylate once daily at the MTD on days 2-5, 9-12, and 16-25 and vinorelbine ditartrate IV, on days 1, 8, and 15.
In both groups and in the PK cohort, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have completed 6 courses of combined therapy may receive additional courses with lapatinib ditosylate alone.
Patients undergo blood collection and buccal brushings periodically for pharmacokinetic and biomarker correlative studies. Archival tumor tissue is also evaluated for biomarkers, including epidermal growth factor receptor (EGFR) and HER-2/neu expression levels, EGFR polymorphisms and gene mutations (including RAS), levels of cellular proliferation and apoptosis, and RAS mutations by immunohistochemistry, mutation analysis, TUNEL assay, and polymerase chain reaction.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
- Being tested
- lapatinib ditosylate, vinorelbine ditartrate, comparative genomic hybridization, cytogenetic analysis, gene expression analysis
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinib ditosylateDrug
Also called Tykerb
Given orally for 28 days per dose level (Dose level 1: 250mg; Dose level 2: 500mg; Dose level 3: 1000mg; Dose level 4: 1250mg; Dose level 5: 1500mg; Dose level 6: 1500mg)
vinorelbine ditartrateDrug
Also called Navelbine
Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 20mg/m2; Dose level 4: 20mg/m2; Dose level 5: 20mg/m2; Dose level 6: 25mg/m2)
comparative genomic hybridizationGenetic
Molecular correlative study
cytogenetic analysisGenetic
Molecular correlative study
gene expression analysisGenetic
Molecular correlative study
mutation analysisGenetic
Molecular correlative study
polymerase chain reactionGenetic
Molecular correlative study
polymorphism analysisGenetic
Molecular correlative study
proteomic profilingGenetic
Molecular correlative study
reverse transcriptase-polymerase chain reactionGenetic
Molecular correlative study
immunohistochemistry staining methodOther
Molecular correlative study
laboratory biomarker analysisOther
Molecular correlative study
lapatinib ditosylateDrug
Also called Tykerb
Given orally on Days 2-5, 9-12 and 16-25 per dose level (Dose level 1: 1250mg; Dose level 2: 1500mg; Dose level 3: 1500mg; Dose level 4: 1700mg)
Vinorelbine ditartrateDrug
Also called Navelbine
Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 25mg/m2; Dose level 4: 25mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| A (Daily Dosing) | Experimental | Oral lapatinib given daily for 28 days plus IV vinorelbine given weekly (3 out of 4 weeks)
Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A. Receives: Drug: lapatinib ditosylate; Drug: vinorelbine ditartrate; Genetic: comparative genomic hybridization; Genetic: cytogenetic analysis; Genetic: gene expression analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Genetic: proteomic profiling; Genetic: reverse transcriptase-polymerase chain reaction; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis |
| B (Intermittent Dosing) | Experimental | Oral lapatinib given days 2-5, 9-12 and 16-25 plus IV vinorelbine given weekly (3 out of 4 weeks)
Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A. Receives: Drug: lapatinib ditosylate; Drug: Vinorelbine ditartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity as assessed by NCI CTCAE v3.0
Measured: Completion of study
Secondary outcomes (6)
Maximum tolerated dose of lapatinib ditosylate when administered with vinorelbine ditartrate as assessed by NCI CTCAE v3.0
Measured: Completion of study
Response rate (complete response, partial response, progressive disease, and stable disease) assessed at baseline and prior to courses 3 and 5
Measured: Completion of study
Best response
Measured: Completion of study
Survival
Measured: Completion of study
Progression-free survival
Measured: Completion of study
Biological markers as predictors of response
Measured: Completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startDec 2005
- Primary completionApr 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Helen K. Chew, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389922
- Sponsor's protocol ID
- CDR0000505878
- Other IDs
- P30CA093373, UCDCC-171, UCDCC-200513681-1, GSK-104241
- Status last verified
- Apr 2012
- First submitted
- 18 Oct 2006
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Two Different Schedules of Lapatinib (GW572016) in Combination With Vinorelbine in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00389922
- Acronym / sponsor ID
- CDR0000505878
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Oct 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.
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with vinorelbine in treating patients with advanced solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the safety and feasibility of 2 different schedules of lapatinib ditosylate when administered with vinorelbine ditartrate in patients with advanced solid tumors.
Secondary
- Determine the maximum tolerated dose (MTD) of each of these regimens in these patients.
- Determine, preliminarily, the efficacy of these regimens in these patients.
- Examine tissue and blood specimens from these patients to investigate potential predictors of response.
- Determine the pharmacokinetics of lapatinib ditosylate and vinorelbine ditartrate in patients treated at the MTD.
OUTLINE: This is a phase I study comprising 2 separate, sequential dose-escalation studies of lapatinib ditosylate. Patients are assigned to 1 of 2 treatment groups.
- Group A (daily dosing): Patients receive oral lapatinib ditosylate once daily on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15.
Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A.
- Pharmacokinetics (PK) cohort*: Patients in the PK cohort receive vinorelbine ditartrate IV as in group A and oral lapatinib ditosylate once daily at the MTD on days 3-28 (course 1 only) and on days 1-28 in all subsequent courses. Patients undergo PK sampling during course 1.
NOTE: *Accrual to group B and to the PK cohort of group A may occur simultaneously.
- Group B (intermittent dosing): Patients receive oral lapatinib ditosylate once daily at the MTD on days 2-5, 9-12, and 16-25 and vinorelbine ditartrate IV, on days 1, 8, and 15.
In both groups and in the PK cohort, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have completed 6 courses of combined therapy may receive additional courses with lapatinib ditosylate alone.
Patients undergo blood collection and buccal brushings periodically for pharmacokinetic and biomarker correlative studies. Archival tumor tissue is also evaluated for biomarkers, including epidermal growth factor receptor (EGFR) and HER-2/neu expression levels, EGFR polymorphisms and gene mutations (including RAS), levels of cellular proliferation and apoptosis, and RAS mutations by immunohistochemistry, mutation analysis, TUNEL assay, and polymerase chain reaction.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (Daily Dosing) | Experimental | Drug: lapatinib ditosylate, Drug: vinorelbine ditartrate, Genetic: comparative genomic hybridization, Genetic: cytogenetic analysis, Genetic: gene expression analysis, Genetic: mutation analysis, Genetic: polymerase chain reaction, Genetic: polymorphism analysis, Genetic: proteomic profiling, Genetic: reverse transcriptase-polymerase chain reaction, Other: immunohistochemistry staining method, Other: laboratory biomarker analysisOral lapatinib given daily for 28 days plus IV vinorelbine given weekly (3 out of 4 weeks) Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A. |
| B (Intermittent Dosing) | Experimental | Drug: lapatinib ditosylate, Drug: Vinorelbine ditartrateOral lapatinib given days 2-5, 9-12 and 16-25 plus IV vinorelbine given weekly (3 out of 4 weeks) Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Cytologically or histologically proven advanced solid tumors for which there is no known standard therapy available or are not eligible for standard therapy because of their performance status, or have progressed after no more than 2 prior chemotherapy regimens for metastatic disease.
- Measurable or evaluable disease. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy.
- 18 years of age or older.
- Zubrod performance status of 0-2.
- Estimated survival of at least 3 months.
Key exclusion criteria (10 listed)
- Patients may not have previously received lapatinib, vinorelbine or any other EGFR-1 targeted agent. Prior trastuzumab is allowed.
- Females cannot be pregnant or breastfeeding
- Symptomatic brain metastasis or still requiring steroids and anticonvulsants may not participate.
- Pre-existing neuropathy > grade 2 may not participate.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, will be excluded.
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 |
|---|---|---|
| lapatinib ditosylateAlso: TykerbGiven orally for 28 days per dose level (Dose level 1: 250mg; Dose level 2: 500mg; Dose level 3: 1000mg; Dose level 4: 1250mg; Dose level 5: 1500mg; Dose level 6: 1500mg) | Drug | A (Daily Dosing) |
| vinorelbine ditartrateAlso: NavelbineGiven IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 20mg/m2; Dose level 4: 20mg/m2; Dose level 5: 20mg/m2; Dose level 6: 25mg/m2) | Drug | A (Daily Dosing) |
| comparative genomic hybridizationMolecular correlative study | Genetic | A (Daily Dosing) |
| cytogenetic analysisMolecular correlative study | Genetic | A (Daily Dosing) |
| gene expression analysisMolecular correlative study | Genetic | A (Daily Dosing) |
| mutation analysisMolecular correlative study | Genetic | A (Daily Dosing) |
| polymerase chain reactionMolecular correlative study | Genetic | A (Daily Dosing) |
| polymorphism analysisMolecular correlative study | Genetic | A (Daily Dosing) |
| proteomic profilingMolecular correlative study | Genetic | A (Daily Dosing) |
| reverse transcriptase-polymerase chain reactionMolecular correlative study | Genetic | A (Daily Dosing) |
| immunohistochemistry staining methodMolecular correlative study | Other | A (Daily Dosing) |
| laboratory biomarker analysisMolecular correlative study | Other | A (Daily Dosing) |
| lapatinib ditosylateAlso: TykerbGiven orally on Days 2-5, 9-12 and 16-25 per dose level (Dose level 1: 1250mg; Dose level 2: 1500mg; Dose level 3: 1500mg; Dose level 4: 1700mg) | Drug | B (Intermittent Dosing) |
| Vinorelbine ditartrateAlso: NavelbineGiven IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 25mg/m2; Dose level 4: 25mg/m2) | Drug | B (Intermittent Dosing) |
Primary outcome
Toxicity as assessed by NCI CTCAE v3.0
Time frame: Completion of study
6 secondary outcomes
Maximum tolerated dose of lapatinib ditosylate when administered with vinorelbine ditartrate as assessed by NCI CTCAE v3.0
Time frame: Completion of study
Response rate (complete response, partial response, progressive disease, and stable disease) assessed at baseline and prior to courses 3 and 5
Time frame: Completion of study
Best response
Time frame: Completion of study
Survival
Time frame: Completion of study
Progression-free survival
Time frame: Completion of study
Biological markers as predictors of response
Time frame: Completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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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.
Helen K. Chew, MD study chair
University of California, Davis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lapatinib ditosylate, vinorelbine ditartrate and comparative genomic hybridization in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of California, Davis at 4 sites 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 14 inclusion and 10 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: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity as assessed by NCI CTCAE v3.0 (time frame: Completion of 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 19 Apr 2012.