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OpenTrials
Completed

NCT Number: NCT02342587

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

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.

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Key information

Conditions

HER2-positive Refractory Advanced Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lapatinib

Drug

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

Primary outcomes

  1. overall response rate

    Time frame: 4 weeks after treatment of lapatinib

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer: A Phase II Single Arm Prospective Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2015
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.