Clinical trial · Interventional
Rollover Study Of Lapatinib In Cancer Patients
An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
NCT00169533CI-TRIAL-00030400completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GW572016 oral tablets | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Lapatinib either 750, 1000, 1250 or 1500 mgs
- interventionNames
- Drug: GW572016 oral tablets
Primary outcomes (1)
- measure
- To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen
- timeFrame
- Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.
Secondary outcomes (1)
- measure
- Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival
- timeFrame
- Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen. * Ability to understand and provide written informed consent to participate in this trial. * Is male or female. * Female and male subjects agree to the protocol specific birth control measures Exclusion Criteria: * Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure. * Is a pregnant or lactating female. * Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations. * Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2). * Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. * Has a left ventricular ejection fraction (LVEF) \< 40% based on MUGA or ECHO.
References
Publications (0)
Data not yet available
No reference posted for this study.