Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Conditions

• HER2-positive Refractory Advanced Cancer

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  Patients will be treated with oral lapatinib 1250mg once daily for 21 days.

Study Details

Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct. Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor. Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.

Key Dates

Start date

Dec 3, 2014

Status verified

Feb 2017

Primary completion

Jan 31, 2016

Completion

Aug 21, 2016

Study Design

Enrollment

7 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: single arm
  Patients will be treated with oral lapatinib 1250mg once daily for 21 days.

Primary Outcome Measure

overall response rate [ Time Frame: 4 weeks after treatment of lapatinib ]