NCT00085020

Brief Summary

RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving GW572016 with trastuzumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

August 3, 2020

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

June 10, 2004

Last Update Submit

July 30, 2020

Conditions

Breast Cancer

Keywords

stage IV breast cancermale breast cancerrecurrent breast cancer

Interventions

trastuzumabBIOLOGICAL
lapatinib ditosylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed breast cancer
  • Metastatic disease
  • Measurable or evaluable disease
  • HER2/neu overexpression (2+ or 3+) confirmed by immunohistochemistry and/or HER2 gene amplification by fluorescence in situ hybridization
  • Brain metastases treated by surgery and/or radiotherapy allowed provided the following criteria are met:
  • Neurologic status stable 2 weeks after discontinuing dexamethasone
  • No concurrent anticonvulsants that induce metabolism (e.g., phenytoin, carbamazepine, or phenobarbital)
  • and over
  • Male or female
  • Karnofsky 70-100%
  • Life expectancy, At least 12 weeks
  • Hematopoietic
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • +16 more criteria

You may not qualify if:

  • extensive tumor, pleural effusions, or parenchymal masses) resulting in dyspnea at rest
  • uncontrolled brain metastases or leptomeningeal disease
  • prior myocardial infarction
  • pre-existing cardiac dysfunction (e.g., congestive heart failure)
  • clinically significant cardiac disease
  • angina pectoris
  • symptomatic intrinsic pulmonary disease (e.g., asthma or chronic obstructive pulmonary disease) resulting in dyspnea at rest
  • pregnant or nursing
  • active infection
  • known hypersensitivity to Chinese Hamster Ovary cell proteins or any component of this product
  • known immediate or delayed hypersensitivity reaction or idiosyncrasy to products of similar chemical composition as study drug
  • known contraindications to trastuzumab (Herceptin\^®)
  • malabsorption syndrome
  • disease significantly affecting gastrointestinal function
  • psychiatric disorder that would preclude study compliance
  • +54 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (2)

  • Storniolo AM, Burris HA III, Overmoyer B, et al.: A phase I, open-label study of the safety, tolerability and pharmacokinetics of lapatinib (GW572016) in combination with trastuzumab. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1040, 2005.

    RESULT

  • Burris III HA, Storniolo AM, Overmoyer EA, et al.: A phase I, open-label study of the safety, tolerability and pharmacokinetics of lapatinib (GW572016) in combination with trastuzumab. [Abstract] Breast Cancer Res Treat 88 (1): A-3043, 2004.

    RESULT

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

TrastuzumabLapatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark D. Pegram, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

March 1, 2004

Primary Completion

December 1, 2004

Study Completion

February 1, 2005

Last Updated

August 3, 2020

Record last verified: 2012-08

Locations

US(1)