Clinical Trials List
Protocol NumberEGF104578
NCT Number(ClinicalTrials.gov Identfier)NCT00486954
2008-03-01 - 2011-12-03
Phase III
Terminated6
ICD-10C16.9
Malignant neoplasm of stomach, unspecified
A Randomized , Multicenter, Open-label, Phase III Study of Lapatinib in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer
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Trial Applicant
GlaxoSmithKline
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Sponsor
GlaxoSmithKline
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Li-Tzong Chen 無
- Tsai-Yun Chen 無
- 夏和雄 無
- Wen-Pin Su 無
- Peng-Chan Lin 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林明賢 無
- 陳昭勳 無
- 陳威宇 無
- 林正耀 無
- 黃文聰 無
- 林建良 無
- 馮盈勳 無
- Shang-Wen Chen 無
- Shang-Hung Chen 無
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
Co-Principal Investigator
- Kun-Huei Yeh 無
- YEN-SHEN LU 無
- Yu-Chieh Tsai 無
- Ann-Lii Cheng 無
- 黃敬倫 無
- Chiun Hsu 無
- 林璟宏 無
- Chih-Hung Hsu 無
- 林宗哲 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 黃麟傑 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Gastric Cancer
Objectives
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.
Test Drug
Lapatinib
Active Ingredient
Lapatinib (GW572016)
Dosage Form
oral tablet
Dosage
Lapatinib Ditosylate250 mg/tablet
Endpoints
Primary Outcome Measures:
1.Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study
2.Overall Survival (OS) in the Randomized Part of the Study
Secondary Outcome Measures:
1.Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study
2.Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study
3.Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study
4.Cmax of Paclitaxel in the Pilot Part of the Study
5.Tmax of Paclitaxel in the Pilot Part of the Study
6.AUC(0-24) of Paclitaxel in the Pilot Part of the Study
7.Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study
8.Half-life of Paclitaxel in the Pilot Part of the Study
9.Clearance of Paclitaxel in the Pilot Part of the Study
10.Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study
11.Progression-free Survival (PFS) in the Randomized Part of the Study
12.Percentage of Participants With Overall Response in the Randomized Part of the Study
13.Time to Progression in the Randomized Part of the Study
14.Number of Participants With the Indicated Time to Response in the Randomized Part of the Study
1.Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study
2.Overall Survival (OS) in the Randomized Part of the Study
Secondary Outcome Measures:
1.Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study
2.Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study
3.Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study
4.Cmax of Paclitaxel in the Pilot Part of the Study
5.Tmax of Paclitaxel in the Pilot Part of the Study
6.AUC(0-24) of Paclitaxel in the Pilot Part of the Study
7.Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study
8.Half-life of Paclitaxel in the Pilot Part of the Study
9.Clearance of Paclitaxel in the Pilot Part of the Study
10.Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study
11.Progression-free Survival (PFS) in the Randomized Part of the Study
12.Percentage of Participants With Overall Response in the Randomized Part of the Study
13.Time to Progression in the Randomized Part of the Study
14.Number of Participants With the Indicated Time to Response in the Randomized Part of the Study
Inclution Criteria
1.Signed informed consent
2.Male or female; ≥ 20 years (at the time of giving consent)
3.Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status
4.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
5.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)
6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
7.Able to swallow and retain oral medication
8.Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study
9.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
10.Willing to complete all screening assessments as outlined in the protocol
11.Adequate organ function as defined in Table 2 Baseline Laboratory Values
12.Able to be hospitalized for PK analysis during cycle 1
13.Life expectancy of at least 12 weeks from the first dose of study treatment)
2.Male or female; ≥ 20 years (at the time of giving consent)
3.Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status
4.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
5.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)
6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
7.Able to swallow and retain oral medication
8.Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study
9.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
10.Willing to complete all screening assessments as outlined in the protocol
11.Adequate organ function as defined in Table 2 Baseline Laboratory Values
12.Able to be hospitalized for PK analysis during cycle 1
13.Life expectancy of at least 12 weeks from the first dose of study treatment)
Exclusion Criteria
1.Pregnant or lactating female at anytime during the study
2.Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment
3.Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2)
4.Peripheral neuropathy of Grade 2 or greater
5.Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded
6.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
7.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
8.Life threatening infection
9.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
10.Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines
11.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
12.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
13.Known history of use of any EGFR agent (except Trastuzumab)
14.Prior gastric cancer treatment which included a taxane.
2.Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment
3.Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2)
4.Peripheral neuropathy of Grade 2 or greater
5.Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded
6.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
7.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
8.Life threatening infection
9.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
10.Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines
11.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
12.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
13.Known history of use of any EGFR agent (except Trastuzumab)
14.Prior gastric cancer treatment which included a taxane.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
260 participants
