Status:
COMPLETED
LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neoplasms, Gastrointestinal Tract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplif...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
- Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease.
- Measurable or non-measurable, but radiologically evaluable disease, according to RECIST.
- HER2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown HER2 status were not eligible.
- Adequate organ function, as defined in the study protocol, assessed within 14 days prior randomization.
- Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO).
- Prior/Concurrent Therapy:
- At least 3 weeks following major surgery, such as gastrectomy, and were recovered from any related toxicity More than 5 years since prior chemotherapy for malignancy other than GC. At least 4 weeks since prior radiotherapy
- More than 5 years since prior biologic or hormonal therapy or immunotherapy for malignancy other than gastric carcinoma.
- Key exclusion criteria:
- Pregnant or lactating females at any time during the study.
- Known history of active CNS disease.
- Uncontrolled ascites.
- Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment.
- Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.
- Prior palliative chemotherapy for the treatment of gastric cancer.
- Prior treatment with oxaliplatin-based neoadjuvant or adjuvant chemotherapy completed \<12 months.
- Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn's disease or ulcerative colitis).
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
- Uncontrolled infection.
- History of other malignancy. However, subjects who were disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, were eligible.
Exclusion
Key Trial Info
Start Date :
June 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT00680901
Start Date
June 4 2008
End Date
October 3 2024
Last Update
August 7 2025
Active Locations (183)
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1
Novartis Investigative Site
Alhambra, California, United States, 91801
2
Novartis Investigative Site
Fullerton, California, United States, 92835
3
Novartis Investigative Site
La Verne, California, United States, 91750
4
Novartis Investigative Site
Northridge, California, United States, 91328