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NCT00371488 Clinical Trial

GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

Neoplasms, Breast Clinical Trial

Official title:
Phase I Study of Lapatinib in Combination With Trastuzumab

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00371488
Other study ID # EGF105635
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 6, 2006
Est. completion date December 10, 2007

Study information
Verified date August 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date December 10, 2007
Est. primary completion date December 10, 2007
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility Inclusion criteria:

- Patients with confirmed breast cancer who have received prior trastuzumab.

- Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.

- Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria:

- Patients with certain heart problems.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GW572016 oral tablets
Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.

Locations
Country Name City State
Japan GSK Investigational Site Saitama
Japan GSK Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan. 6 Months
Secondary Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue 6 Months
See also
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Withdrawn NCT01137994 - A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer Phase 2
Completed NCT00790816 - Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents Phase 1
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Completed NCT00320411 - GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer Phase 2
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Terminated NCT00479856 - Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer Phase 2
Completed NCT00320385 - Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer Phase 3
Completed NCT00062686 - GW572016 For Treatment Of Refractory Metastatic Breast Cancer Phase 2
Completed NCT00996762 - A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib Phase 1
Terminated NCT02913729 - Pre- Versus Postoperative Accelerated Partial Breast Irradiation N/A
Completed NCT01160211 - A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer Phase 3
Recruiting NCT05814224 - Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA N/A
Completed NCT01815294 - A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer Phase 1
Terminated NCT00437073 - Brain Metastases In ErbB2-Positive Breast Cancer Phase 2
Completed NCT00356811 - Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer Phase 2

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