NCT00544804

Brief Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Aug 2007

Longer than P75 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

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

5.8 years

First QC Date

October 13, 2007

Last Update Submit

July 1, 2014

Conditions

Breast CancerMetastatic Cancer

Keywords

recurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerbone metastases

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of Lapatinib

    Dose Escalation of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer

    estimated to be 12 months

Study Arms (1)

Lapatinib

EXPERIMENTAL

Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer

Drug: lapatinib ditosylateGenetic: gene expression analysisOther: diagnostic laboratory biomarker analysis

Interventions

lapatinib ditosylateDRUG
Lapatinib
gene expression analysisGENETIC
Lapatinib
diagnostic laboratory biomarker analysisOTHER
Lapatinib

Eligibility Criteria

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

You may qualify if:

  • ECOG performance status 0-2
  • Life expectancy \> 3 months
  • Female
  • Menopausal status not specified
  • Absolute neutrophil count ≥ 1,000 cells/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 75,000 cells/mm\^3
  • Total bilirubin normal
  • AST and ALT ≤ 3 x upper limits of normal (ULN) (≤ 5 x ULN with liver metastases)
  • Creatinine normal OR creatinine clearance ≥ 40 mL/min
  • INR ≤ 1.5
  • Potassium normal
  • Magnesium normal
  • Not pregnant
  • Negative pregnancy test
  • +4 more criteria

You may not qualify if:

  • History of significant cardiac disease including any of the following:
  • Congestive heart failure
  • Symptomatic cardiac arrhythmias
  • Unstable angina
  • Uncontrolled prior lapatinib ditosylate therapy toxicity ≥ grade 2
  • Allergic reactions to IV contrast dye despite standard prophylaxis
  • History of malabsorption syndrome or disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism, or excretion of study drug
  • Conditions that would impair the patient's ability to swallow and retain oral medication
  • Concurrent disease or condition that would make the patient inappropriate for study participation or would interfere with the patient's safety
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
  • PRIOR CONCURRENT THERAPY:
  • Prior lapatinib ditosylate or trastuzumab allowed
  • At least 4 weeks since prior and no concurrent chemotherapy or investigational anticancer agents
  • At least 2 weeks since prior and no concurrent hormonal therapy
  • At least 2 weeks since prior and no concurrent lapatinib ditosylate prohibited medications, including CYP3A4 inhibitors or inducers, all herbal supplements, and gastric pH modifiers
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Chien AJ, Munster PN, Melisko ME, Rugo HS, Park JW, Goga A, Auerback G, Khanafshar E, Ordovas K, Koch KM, Moasser MM. Phase I dose-escalation study of 5-day intermittent oral lapatinib therapy in patients with human epidermal growth factor receptor 2-overexpressing breast cancer. J Clin Oncol. 2014 May 10;32(14):1472-9. doi: 10.1200/JCO.2013.52.1161. Epub 2014 Apr 7.

    PMID: 24711549RESULT

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

LapatinibGene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGenetic TechniquesInvestigative Techniques

Study Officials

  • Mark M. Moasser, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2007

First Posted

October 16, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

US(1)