Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lapatinib ditosylate · 1 trial · 1 indication
cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)\>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease \<=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
| Arm | Type | Description |
|---|---|---|
| Treatment arm | EXPERIMENTAL | 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| lapatinib ditosylate | DRUG | Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. |
| paclitaxel albumin-stabilized nanoparticle formulation | DRUG | 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. |
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Clinical stage I-III disease * Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm with spiral CT scan * HER2/neu 3+ by immunohistochemistry or positive by fluoresce...
Top 20 of 92 competitors
Lapatinib ditosylate is a small molecule being studied for the treatment of breast cancer. It is an investigational drug, currently in early Phase 1 clinical development, and has not been approved by the FDA. It is being evaluated in a completed clinical trial involving patients with stage I, stage II, or stage III breast cancer.
Lapatinib ditosylate is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The drug is currently in Phase 1 clinical development for the treatment of breast cancer.
Lapatinib ditosylate is in Phase 1 clinical development. Specifically, it has been studied in an early Phase 1 trial, which has been completed. The drug is investigational and has not been approved by the FDA for any use.
Lapatinib ditosylate has been studied in one clinical trial with the identifier NCT00331630. This trial, titled 'Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer,' was an early Phase 1 study conducted in the United States. The trial enrolled 30 participants and has been completed.
Lapatinib ditosylate is a salt form of lapatinib. The drug is being developed by GSK plc for the treatment of breast cancer. It is currently in Phase 1 clinical development, with one completed early Phase 1 trial (NCT00331630) that enrolled 30 patients.