Neoplasms, Gastrointestinal TractPhase 3NCT00486954
Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer
A Phase 3 study testing Lapatinib and Paclitaxel in people with Neoplasms, Gastrointestinal Tract, run by GlaxoSmithKline at 17 sites in 4 countries.
Trial summary
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms, Gastrointestinal Tract
- What is being tested?
- Lapatinib and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Jul 2007to Oct 2012
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator's Brochure (IB) Pilot Part
- Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following criteria:
- Signed informed consent
- Male or female; ≥ 20 years (at the time of giving consent)
- Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status
- Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin
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- Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Able to swallow and retain oral medication
- Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study
- Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (I.V) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks
- Willing to complete all screening assessments as outlined in the protocol
- Adequate organ function as defined in Table 2 Baseline Laboratory Values
- Able to be hospitalized for PK analysis during cycle 1
- Life expectancy of at least 12 weeks from the first dose of study treatment)
- Randomized Part
- Subjects eligible for enrollment in the Randomized Part of the study must meet all of the following criteria:
- Signed informed consent
- Male or female; ≥ 20 years (at the time of giving consent)
- Histologically or cytologically confirmed gastric carcinoma with documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue
- Subjects who received one prior regimen for gastric carcinoma and defined as progression disease. The regimen must be containing 5-fluoropyrimidine and/or cisplatin
- Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors)
- Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution)
- ECOG Performance Status of 0 to 1
- Able to swallow and retain oral medication
- Archived (or Biopsy ) tumor tissue available for FISH testing [Wolff, 2007] in central laboratory
- Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study
- Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (IV) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks
- Willing to complete all screening assessments as outlined in the protocol
- Adequate organ function as defined in Table 2
- Gastrectomy status depending on the result in the Pilot Part
- Life expectancy of at least 12 weeks from the first dose of study treatment
- Table 2 Baseline Laboratory Values
- SYSTEM LABORATORY (VALUES)
- Hematologic:
- ANC (absolute neutrophil count)
- Hemoglobin:
- Platelets (≥ 2.0 × 10^9/L) (≥ 9 g/dL) (≥ 100 × 10^9/L) Hepatic Albumin Serum bilirubin AST and ALT (≥ 2.5 g/dL) (≤ 1.25 x ULN) (≤ 2.5 × ULN without liver metastases) (≤ 5 × ULN if documented liver metastases) Renal Serum Creatinine
- Calculate Creatinine Clearance (see Section 11.3) (≤ 2.0 mg/dL)
- OR - (≥30 mL/min)
Who cannot join
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Pregnant or lactating female at anytime during the study
- Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment
- Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2)
- Peripheral neuropathy of Grade 2 or greater
- Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded
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- History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
- Life threatening infection
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
- Known history or clinical evidence of central nervous system (CNS) metastasis
- Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines
- Concurrent treatment with an investigational agent within 28 days prior to the administration of paclitaxel and/or lapatinib
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel, including polyethoxylated castor oil, alcohol, or lapatinib or their excipients
- Anamnesis or diagnosis of pulmonary disorder, such as interstitial pneumonia, pulmonary fibrosis or serious hypoxia
- Gastrectomy surgery if Pilot Part of the study determines that partial gastrectomy (pylorus spared) or total/partial gastrectomy (pylorus removed) has a significant negative impact upon lapatinib PK and safety profile
- Known history of use of any EGFR agent (except Trastuzumab)
- Prior gastric cancer treatment which included a taxane.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Taiwan7 sites
GSK Investigational Site
Kaohsiung City, 807
GSK Investigational Site
Niaosong Township, Kaohsiung, 833
GSK Investigational Site
Tainan, 704
GSK Investigational Site
Tainan County, 736
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 112
GSK Investigational Site
Tau-Yuan County, 333
South Korea5 sites
GSK Investigational Site
Hwasun, 519-809
GSK Investigational Site
Seongnam-si Gyeonggi-do, 463-707
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 135-710
China4 sites
GSK Investigational Site
Beijing, 100021
GSK Investigational Site
Beijing, 100071
GSK Investigational Site
Guangzhou, Guangdong, 510060
GSK Investigational Site
Shanghai, 200032
About this study
Official title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone in the Second Line Treatment of ErbB2 Amplified Advanced Gastric Cancer
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.
- Conditions
- Neoplasms, Gastrointestinal Tract
- Being tested
- Lapatinib, Paclitaxel
- Keywords
- lapatinib, paclitaxel, ErbB2, Gastric cancer, Advanced gastric cancer
- Medical subject headings
- Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
Also called Lapatinib: Tykerb, Tyverb
6 pills at 250 mg each once daily
PaclitaxelDrug
Infusion at 80 mg/m2 weekly
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel plus Lapatinib | Experimental | 6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly Receives: Drug: Lapatinib; Drug: Paclitaxel |
| Paclitaxel alone | Active comparator | Infusion of paclitaxel at 80 mglm2 weekly Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study
DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting >=7 days, thrombocytopenia (<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of >5 days, for Days 8 or 15 of weekly paclitaxel.
Measured: 28 days
Overall Survival (OS) in the Randomized Part of the Study
OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.
Measured: From randomization until death due to any cause (up to 42.58 months)
Secondary outcomes (43)
Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study
Pharmacokinetic (PK) samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.
Measured: Days 8 and 14
Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study
PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.
Measured: Days 8 and 14
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study
PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14. AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after oral adminisation.
Measured: Days 8 and 14
Cmax of Paclitaxel in the Pilot Part of the Study
PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.
Measured: Days 1 and 8
Tmax of Paclitaxel in the Pilot Part of the Study
PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.
Measured: Days 1 and 8
AUC(0-24) of Paclitaxel in the Pilot Part of the Study
PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from the start of infusion (time 0) to 24 hours after the start of the infusion.
Measured: Days 1 and 8
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study
PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-inf) is area under the plasma concentration-time curve from the start of infusion (time 0) extrapolated to infinity.
Measured: Days 1 and 8
Half-life of Paclitaxel in the Pilot Part of the Study
PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half.
Measured: Days 1 and 8
Clearance of Paclitaxel in the Pilot Part of the Study
PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Clearance is defined as the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.
Measured: Days 1 and 8
Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study
PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Vss is the volume of distribution at steady state of paclitaxel.
Measured: Days 1 and 8
Progression-free Survival (PFS) in the Randomized Part of the Study
PFS was defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Measured: From randomization until disease progression or death due to any cause (up to 42.35 months)
Time to Progression in the Randomized Part of the Study
Time to progression was defined as the time from randomization until the earliest date of disease progression or death due to disease. Per RECIST, version 1.0, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Measured: From randomization until disease progression or death due to disease (up to 42.35 months )
Percentage of Participants With Overall Response in the Randomized Part of the Study
Overall response was defined as the percentage of participants achieving either complete response (CR) or partial response (PR). Per RECIST, version 1.0, CR was defined as the disappearance of all target lesions, and PR was defined as a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: From randomization up to 5.62 months
Number of Participants With the Indicated Time to Response in the Randomized Part of the Study
Time to response was defined as the time from randomization to CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD). For participants who did not achieve a CR or PR, time to response was censored at the last assessment prior to other cancer therapies. For censored participants, time to response was defined as the time from randomization to the time of the last assessment prior to the administation of other cancer therapies.
Measured: up to 5.62 months
Duration of Response in the Randomized Part of the Study
Duration of response was defined as the time from the first documented evidence of CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD) until the first documented sign of disease progression (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions) or death due to any cause, if sooner.
Measured: up to 18.27 months
Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study
The Common Terminology Criteria for Advere Events (CTCAE) is a descriptive terminology that can be used for AE reporting. Grade (G) refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade (G) refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE.
Measured: From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study
The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Measured: Baseline and end of therapy (up to 42.58 months)
Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study
EGFR protein expression on the surface of cells in gastric cancer tissue samples was measured using a moncolonal antibody specific for the extracellular region of EGFR, and the degree of membrane staining was evaluated. 3+ indicates positive EGFR expression; <3+ indicates negative EGFR expression.
Measured: Pretreatment
Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study
HER2 protein expression on the surface of cells in gastric cancer tissue samples was measured using a monoclonal antibody specific for the extracellulr region of HER2, and the degree of membrane staining was evaulated. The immunohistochemistry test gives a score of 0 to 3+ and measures the amount of HER2 receptor protein on the surface of cells in a gastric cancer tissue sample. Score of 0 to 1+, "HER2 negative"; score of 2+, "borderline"; score of 3+, "HER2 positive."
Measured: Pretreatment
Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib
An inadequate number of tissue samples were obtained; thus, analysis could not be performed.
Measured: Pretreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2012
- Study completionOct 2012
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.
- Other trials for Neoplasms, Gastrointestinal TractStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 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
- NCT00486954
- Sponsor's protocol ID
- 104578
- Status last verified
- Jan 2013
- First submitted
- 13 Jun 2007
- Last updated
- 20 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone in the Second Line Treatment of ErbB2 Amplified Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00486954
- Acronym / sponsor ID
- 104578
- Conditions
- Neoplasms, Gastrointestinal Tract
- Keywords
- lapatinib, paclitaxel, ErbB2, Gastric cancer, Advanced gastric cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Jun 2007 (estimated)
- Results
- Posted 7 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel plus Lapatinib | Experimental | Drug: Lapatinib, Drug: Paclitaxel6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly |
| Paclitaxel alone | Active comparator | Drug: PaclitaxelInfusion of paclitaxel at 80 mglm2 weekly |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator's Brochure (IB) Pilot Part
- Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following criteria:
- Signed informed consent
- Male or female; ≥ 20 years (at the time of giving consent)
- Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status
Key exclusion criteria (19 listed)
- Pregnant or lactating female at anytime during the study
- Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment
- Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2)
- Peripheral neuropathy of Grade 2 or greater
- Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also 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 |
|---|---|---|
| LapatinibAlso: Lapatinib: Tykerb, Tyverb6 pills at 250 mg each once daily | Drug | Paclitaxel plus Lapatinib |
| PaclitaxelInfusion at 80 mg/m2 weekly | Drug | Paclitaxel alone, Paclitaxel plus Lapatinib |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study
Time frame: 28 days
DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting >=7 days, thrombocytopenia (<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of >5 days, for Days 8 or 15 of weekly paclitaxel.
Overall Survival (OS) in the Randomized Part of the Study
Time frame: From randomization until death due to any cause (up to 42.58 months)
OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.
43 secondary outcomes
Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study
Time frame: Days 8 and 14
Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study
Time frame: Days 8 and 14
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study
Time frame: Days 8 and 14
Cmax of Paclitaxel in the Pilot Part of the Study
Time frame: Days 1 and 8
Tmax of Paclitaxel in the Pilot Part of the Study
Time frame: Days 1 and 8
AUC(0-24) of Paclitaxel in the Pilot Part of the Study
Time frame: Days 1 and 8
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study
Time frame: Days 1 and 8
Half-life of Paclitaxel in the Pilot Part of the Study
Time frame: Days 1 and 8
Clearance of Paclitaxel in the Pilot Part of the Study
Time frame: Days 1 and 8
Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study
Time frame: Days 1 and 8
Progression-free Survival (PFS) in the Randomized Part of the Study
Time frame: From randomization until disease progression or death due to any cause (up to 42.35 months)
Time to Progression in the Randomized Part of the Study
Time frame: From randomization until disease progression or death due to disease (up to 42.35 months )
Percentage of Participants With Overall Response in the Randomized Part of the Study
Time frame: From randomization up to 5.62 months
Number of Participants With the Indicated Time to Response in the Randomized Part of the Study
Time frame: up to 5.62 months
Duration of Response in the Randomized Part of the Study
Time frame: up to 18.27 months
Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study
Time frame: From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study
Time frame: Baseline and end of therapy (up to 42.58 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lapatinib and Paclitaxel in people with Neoplasms, Gastrointestinal Tract, run by GlaxoSmithKline at 17 sites in 4 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 40 inclusion and 19 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Taiwan, South Korea, China, Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Feb 2013). 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?
Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study (time frame: 28 days). The study lists 2 primary outcomes in all. 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 20 Jun 2013.