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Also known as GW572016 oral tablets, GW572016 (Lapatinib)
GW572016 · 4 trials · 1 indication
Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.
Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.
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.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks |
| Arm 2 | PLACEBO_COMPARATOR | Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo |
| GW572016 in combination with trastuzumab | EXPERIMENTAL | Lapatinib: A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible. The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria. Trastuzumab: Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals. |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Active Comparator |
| GW572016 (Lapatinib) | DRUG | Oral GW572016 Lapatinib |
| GW572016 | DRUG | - |
| GW572016 oral tablets | DRUG | Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets. |
Inclusion criteria: * Signed Informed Consent * Able to swallow an oral medication * Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram * Adequate kidney and liver function * Adequate bone marrow function * Tumor tissue available for testing * Prior adj...
GW572016 is an investigational oral small molecule being studied in oncology for the treatment of neoplasms and breast cancer, including advanced or metastatic disease. It has been evaluated as first line therapy in combination with paclitaxel and in patients previously treated with trastuzumab.
GW572016 is developed by GSK plc, which trades under the ticker GSK. The company has sponsored the clinical development program for the drug across multiple international study sites.
GW572016 has reached Phase 3 clinical development. Its Phase 3 trial, NCT00075270, evaluated paclitaxel with or without GW572016 as first line therapy for women with advanced or metastatic breast cancer and enrolled 580 patients.
Four completed trials have studied GW572016: NCT00075270, a Phase 3 trial in advanced or metastatic breast cancer; NCT00062686, a Phase 2 trial in refractory metastatic breast cancer; NCT00371488, a Phase 1 trial combined with trastuzumab in Japan; and NCT00169533, a Phase 1 rollover study.
Yes. GW572016 is the compound code for lapatinib, and the two names refer to the same oral small molecule drug. It is also described as GW572016 oral tablets or GW572016 (Lapatinib) in study documentation.
Across the four completed trials, 822 patients have been enrolled in GW572016 studies. The largest was the Phase 3 trial NCT00075270 with 580 participants, followed by the Phase 2 trial NCT00062686 with 200 participants.