Neoplasms, ColorectalPhase 1NCT00536809
Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer
A Phase 1 study testing lapatinib, oxaliplatin and capecitabine in people with Neoplasms, Colorectal, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Colorectal
- What is being tested?
- lapatinib, oxaliplatin and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2007to 31 Oct 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older.
- A female is eligible to enter and participate in the study if she is of:
- Non-child-bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- Has had a hysterectomy, or
- Has had a bilateral oophorectomy (ovariectomy), or
- Has had a bilateral tubal ligation, or
Show all 33Show fewer
- Is considered post-menopausal (defined as amenorrheic for greater than or equal to 1 year).
- Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the following from 2 weeks prior to enrolment and continue through the post-study visit:
- Complete abstinence from sexual intercourse
- Oral Contraceptive, either combined or progestogen alone (must use a back up method, if have taken for less than 3 cycles)
- Injectable progestogen
- Implants of levonorgestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
- Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
- Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
- Provided written informed consent.
- Hemoglobin greater than or equal to 8 gm/dL (5 nmol/L), if clinically stable.
- Absolute neutrophil count greater than or equal to 1,500/mm^3 (1.5 x 109/L).
- Calculated creatinine clearance (CrCl) greater than or equal to 50 mls/min.
- Total bilirubin less than or equal to 1.25 times the institutional upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2 times the ULN. For subjects with liver metastases: AST or ALT less than or equal to 5 times the ULN.
- LVEF greater than or equal to 50% or greater than or equal to LLN for the institution based on multiple gated acquisition scan (MUGA) or echocardiogram (ECHO).
- Specific to Phase I:
- Recurrent, advanced, or metastatic cancer that is known to be potentially responsive to treatment with fluoropyrimidines or oxaliplatin. Examples include gastrointestinal tumors, HER2 (ErbB2)-positive breast cancer, and lung cancers.
- Received less than or equal to 3 prior chemotherapy regimens without pelvic radiotherapy or less than or equal to 2 prior chemotherapy regimens if received pelvic radiotherapy.
- Platelet count greater than or equal to 75,000/mm^3 (75 x 109/L).
- Specific to Phase II:
- Histologically-confirmed, measurable advanced or metastatic CRC previously untreated in the metastatic setting or more than 6 months post an oxaliplatin-containing adjuvant therapy.
- Archived paraffin-embedded tumor tissue must be available for biomarker analysis.
- Platelet count greater than or equal to 100,000/mm^3 (100 x 109/L).
Who cannot join
- Pregnant or lactating female.
- Prior resection of the small bowel.
- Brain metastases that require additional treatment.
- Medically unfit for the study as a result of the medical interview, physical exam, or screening investigations.
- Taking any medication on the prohibited medications list (see Section 9.2).
- History of drug or other allergy, which, in the opinion of the Investigator, contraindicates participation.
Show all 17Show fewer
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs. These include other anilinoquinazolines, such as gefitinib [Iressa], or erlotinib [Tarceva]. The subject has received treatment with any investigational drug in the previous four weeks.
- Treatment with any biologic, cytotoxic, radiation , or hormonal (other than for contraception or replacement) therapy within four weeks. Treatment with hormones with short half-lives is allowed up to 1 week prior to study treatment after consultation with GSK medical monitor.
- Major surgery within the previous two weeks unless in the opinion of the Investigator, the subject has recovered sufficiently to begin study treatment.
- Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Receiving concurrent coumadin therapy. Minidose coumadin for maintenance of catheters (0.5 to 1.0 mg/day), and other anticoagulation therapy are allowed on study. Subjects receiving minidose coumadin must have prothrombin time (PT) or International normalized ratio (INR) and partial thromboplastin time (PTT) within 1.2 times the ULN.
- History of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
- Corrected QT interval (QTc) greater than 450 msecs.
- Specific to Phase I:
- Residual chemotherapy related toxicity of greater than or equal to Grade 2 that is clinically felt likely to be exacerbated by the treatment regimen.
- Specific to Phase II (amendment written after the completion of Phase 1):
- Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced or Metastatic Colorectal Cancer
The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.
- Conditions
- Neoplasms, Colorectal
- Being tested
- lapatinib, oxaliplatin, capecitabine
- Keywords
- Metastatic Colorectal Cancer, oxaliplatin, fluoropyrimidines cancers, Advanced Colorectal Cancer, capecitabine, lapatinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinibDrug
onced daily Days 1-21
oxaliplatinDrug
Day one of each cycle
capecitabineDrug
Also called lapatinib, oxaliplatin
given BID days 1-14
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Dose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached. Receives: Drug: oxaliplatin |
| Phase II | Experimental | Treatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin Receives: Drug: lapatinib; Drug: oxaliplatin; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response in Phase II
The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study.
Measured: Baseline to response (up to 135 days)
Secondary outcomes (17)
Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies.
Exploring if there is an association with a reduction in thymidylate synthase (TS) gene expression in both plasma and tumor prior to treatment and increased sensitivity in clinical activity. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening.
Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response
A possible association between a reduction in thymidylate synthase (TS) gene expression and increased sensitivity in clinical activity was to be explored. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible).
Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment
Exploring tumor-derived biomarkers including TS, DPD, TP, EGFR (ErbB1), and additional downstream markers involved in the mechanism of action of each compound (e.g., ERCC1) and comparison to clinical response. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days.
Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy
DNA sequencing was done to identify genetic aberrations in somatic (tumor) DNA that may associate with clinical outcomes in response to therapy. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3.
Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs
This outcome measure was conducted to investigate a possible genetic relationship to handling or response to lapatinib, oxaliplatin, and capecitabine. This measure was not analyzed due to the small number of participants who signed the optional pharmacogenetics consent.
Measured: Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible
Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II
Both participants that entered Phase II of the study were censored for progression-free survival. Progression-free survival (PFS) is defined as the time from first dose until the first documented sign of disease progression or death due to any cause. For participants who do not progress or die, PFS was censored at the time of last radiological scan preceding the initiation of alternative anti-cancer therapy. Of the 2 participants in Phase II of the study, one discontinued due to adverse events, and the other was referred for a surgical resection.
Measured: Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days)
Change From Baseline to Study Completion in Weight
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Heart Rate
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Blood Pressure
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Hemoglobin and Neutrophils
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in White Blood Cells and Platelets
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in International Normalized Ratio
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Sodium, Potassium, and Calcium
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Creatinine Clearance
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase
Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.
Measured: Baseline to study completion (up to 135 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study start26 Sep 2007
- Primary completion31 Oct 2008
- Study completion31 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, ColorectalStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT00536809
- Sponsor's protocol ID
- EGF108991
- Status last verified
- Nov 2017
- First submitted
- 27 Sep 2007
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dennie TW, Fleming RA, Bowen CJ, Dar MM, Alberti D, Oliver K, Loconte N, Mulkerin D, Holen KD. A phase I study of capecitabine, oxaliplatin, and lapatinib in metastatic or advanced solid tumors. Clin Colorectal Cancer. 2011 Mar 1;10(1):57-62. doi: 10.3816/CCC.2011.n.008.
PubMed 21609937
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00536809
- Acronym / sponsor ID
- EGF108991
- Conditions
- Neoplasms, Colorectal
- Keywords
- Metastatic Colorectal Cancer, oxaliplatin, fluoropyrimidines cancers, Advanced Colorectal Cancer, capecitabine, lapatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2007 (actual)
- Primary completion
- 31 Oct 2008 (actual)
- Study completion
- 31 Oct 2008 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Posted 9 Jun 2010
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 highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: oxaliplatinDose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached. |
| Phase II | Experimental | Drug: lapatinib, Drug: oxaliplatin, Drug: capecitabineTreatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 18 years of age or older.
- A female is eligible to enter and participate in the study if she is of:
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
- Provided written informed consent.
- Hemoglobin greater than or equal to 8 gm/dL (5 nmol/L), if clinically stable.
Key exclusion criteria (17 listed)
- Pregnant or lactating female.
- Prior resection of the small bowel.
- Brain metastases that require additional treatment.
- Medically unfit for the study as a result of the medical interview, physical exam, or screening investigations.
- Taking any medication on the prohibited medications list (see Section 9.2).
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 |
|---|---|---|
| lapatinibonced daily Days 1-21 | Drug | Phase II |
| oxaliplatinDay one of each cycle | Drug | Phase I, Phase II |
| capecitabineAlso: lapatinib, oxaliplatingiven BID days 1-14 | Drug | Phase II |
Primary outcome
Overall Response in Phase II
Time frame: Baseline to response (up to 135 days)
The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study.
17 secondary outcomes
Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies.
Time frame: Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening.
Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response
Time frame: Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible).
Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment
Time frame: Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days.
Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy
Time frame: Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3.
Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs
Time frame: Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible
Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II
Time frame: Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days)
Change From Baseline to Study Completion in Weight
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Heart Rate
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Blood Pressure
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Hemoglobin and Neutrophils
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in White Blood Cells and Platelets
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in International Normalized Ratio
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Sodium, Potassium, and Calcium
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Creatinine Clearance
Time frame: Baseline to study completion (up to 135 days)
Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase
Time frame: Baseline to study completion (up to 135 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21609937Dennie TW, Fleming RA, Bowen CJ, Dar MM, Alberti D, Oliver K, Loconte N, Mulkerin D, Holen KD. A phase I study of capecitabine, oxaliplatin, and lapatinib in metastatic or advanced solid tumors. Clin Colorectal Cancer. 2011 Mar 1;10(1):57-62. doi: 10.3816/CCC.2011.n.008.
- Results for study EGF108991 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
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 lapatinib, oxaliplatin and capecitabine in people with Neoplasms, Colorectal, run by GlaxoSmithKline 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 33 inclusion and 17 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 18 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response in Phase II (time frame: Baseline to response (up to 135 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536809, which also lists 1 linked publication.
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 18 Dec 2017.