Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02342587
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

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.


Condition or disease Intervention/treatment Phase
HER2-positive Refractory Advanced Cancer Drug: Lapatinib Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer: A Phase II Single Arm Prospective Study
Actual Study Start Date : December 3, 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single arm
Patients will be treated with oral lapatinib 1250mg once daily for 21 days.
Drug: Lapatinib
Patients will be treated with oral lapatinib 1250mg once daily for 21 days.




Primary Outcome Measures :
  1. overall response rate [ Time Frame: 4 weeks after treatment of lapatinib ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342587


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

Layout table for additonal information
Responsible Party: Jeeyun Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02342587     History of Changes
Other Study ID Numbers: 2014-10-028
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Jeeyun Lee, Samsung Medical Center:
Lapatinib

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action