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

NCT02342587 | Completed Phase 2

• 1 other identifier: 2014-10-028
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Refractory Advanced Cancer

Keywords

Lapatinib

Outcome Measures

Primary Outcomes (1)

• overall response rate

  4 weeks after treatment of lapatinib

Study Arms (1)

single arm

EXPERIMENTAL

Patients will be treated with oral lapatinib 1250mg once daily for 21 days.

Drug: Lapatinib

Interventions

Lapatinib DRUG

Patients will be treated with oral lapatinib 1250mg once daily for 21 days.

single arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 19
• Written informed consent
• ECOG 0-2,
• Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
• The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
• Adequate organ function

You may not qualify if:

• Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
• Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
• Prolonged QT interval in ECG (QTc \>450 msec)
• Pregnant, lactating women
• Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
• Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Lapatinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: December 3, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 21, 2016
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

KR (1)