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

Conditions

• Neoplasms, Gastrointestinal Tract

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  5 pills at 250mg each once daily
• Placebo — DRUG
  5 pills once daily
• Capecitabine — DRUG
  1700mg/m2/day in two daily doses
• Oxaliplatin — DRUG
  130mg/m2 on day 1

Study Details

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 amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.

Key Dates

Start date

Jun 4, 2008

Status verified

Jul 2025

Primary completion

Sep 24, 2012

Completion

Oct 3, 2024

Study Design

Enrollment

545 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CapeOx plus Lapatinib
  CapeOx plus Lapatinib
• Placebo Comparator: CapeOx plus Placebo
  CapeOx plus Placebo

Primary Outcome Measure

Overall Survival at the Time of Primary Analysis [ Time Frame: From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) ]

Locations (10)

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