Lapatinib
Clinical Trials Overview
7 trials found
About Lapatinib
Lapatinib is an oral tyrosine kinase inhibitor that blocks both EGFR and HER2 receptors. In colorectal cancer, it has been evaluated primarily in patients with refractory disease who have progressed on standard chemotherapy regimens including 5-fluorouracil, irinotecan, and oxaliplatin. The drug is typically used in combination with chemotherapy agents such as capecitabine and oxaliplatin for patients with advanced colorectal adenocarcinoma. Lapatinib may be particularly relevant for colorectal tumors with HER2 amplification or overexpression.
Category
Targeted Therapy
Brand Name
Tykerb
Mechanism
Lapatinib works by reversibly binding to the ATP-binding site of both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) tyrosine kinases. This dual inhibition blocks downstream signaling pathways including PI3K/AKT and RAS/RAF/MEK/ERK cascades that promote tumor cell proliferation, survival, and metastasis.
Efficacy Data by Mutation
Response rates and survival outcomes by patient molecular profile
HER2 IHC 3+ or FISH+
Level 2A
30%
ORR
4.7m
PFS
10m
OS
n=27
Sample
7
Total Trials
0
Recruiting
0
Active
7
Completed
156
Total Enrollment
4
Countries
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Number of trials started per year
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Phase:
NCT03418558
Phase 2
Completed
Medications:
Lapatinib
Trastuzumab
This is a phase II, open label, multicenter study. Patients with advanced colon rectal cancer (CRC) harboring an amplified HER2 that have been previously treated and progressed with an aNti-HER2 treatment, will be treated with the anti HER2 antibody ...
Italy
NCT02230553
Phase 1
Completed
35 patients
Medications:
Lapatinib
Trametinib
This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type...
Netherlands
NCT03225937
Phase 2
Completed
This is a Phase II multi-center 2-sequential cohorts trial, designed to assess the objective response rate of two anti HER2 combination in advanced disease CRC patients harbouring an amplified HER2 tumor assessed according to HERACLES Diagnostic Crit...
Italy
NCT01184482
Phase 1
Completed
Medications:
Cetuximab
Lapatinib
This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy.
Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this ...
United States
NCT00536809
Phase 1
Completed
12 patients
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 pre...
United States
NCT00574171
Phase 2
Completed
29 patients
Medications:
Capecitabine
Lapatinib
The purpose of this study is to find out how effective this combination is as a second line treatment for colorectal cancer that has spread from one part of the body to another (metastasized) or has not metastasized but is considered inoperable (unab...
United States
NCT00044343
Phase 2
Completed
80 patients
Medications:
Lapatinib
The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.
United States, Canada