Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lapatinib and temozolomide · 3 trials · 6 indications
Benefit is defined as complete response, partial response, or stable disease according to RECIST criteria (vers. 1.1). Efficacy criteria is the number of patients meeting this definition. Patients having stopped before this 4-months time point will be considered as non responders without clinical benefit.
The criteria is the number of patients for whom a toxicity event (according to the NCI-CTC AE vers.4)and/or an impact on functional status (defined by the 8 items IADL assessment scale) has been observed during the first 4 months of treatment.
CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A "complete response" is defined as the disappearance of all target or non-target lesions, "partial response" and "disease progression" as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and "stable disease" as neither "partial response" nor "disease progression."
| Arm | Type | Description |
|---|---|---|
| Lapatinib + Capecitabine | EXPERIMENTAL | lapatinib 1250 mg/day (once daily) Capecitabine 2x850 mg/m2/day, days 1-14 during the first cycle and 2x1000 mg/m2/day, days 1-14, every 21 days for following cycles ( if no unacceptable toxicity is observed). |
| Lapatinib+capecitabine | EXPERIMENTAL | Lapatinib 1250mg once daily +capecitabine 2000mg/m\^2 twice daily (14 days out of 21 days) |
| I | EXPERIMENTAL | Lapatinib plus temozolomide |
| Name | Type | Description |
|---|---|---|
| lapatinib + capecitabine | DRUG | For Lapatinib: 5 tablets of 250 mg each, once daily, until disease progression or unacceptable toxicity occurence. For Capecitabine: 850 mg/m2 twice a day from day 1 to 14 of cycle 1 and 1000 mg/m2 twice a day from day 1 to 14 of the next cycles. |
| Lapatinib | DRUG | 1250mg once daily |
| capecitabine | DRUG | 2000mg/m\^2 twice daily (14 days out of 21 days) |
| lapatinib and temozolomide | DRUG | Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day. |
Inclusion Criteria: * Age ≥ 70 * Histological confirmed advanced breast cancer (metastatic or locally advanced) * Tumor over expressing HER2 (HER2 3+ in IHC or IHC 2+ and Fish positive) in sample from the primary and/or secondary tumor * WHO performance status (EGOG) from 0 to 2 * MMS \> 25 * Measu...
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Lapatinib is an investigational small molecule being studied for multiple oncology indications, including metastatic breast cancer, metastatic colorectal cancer, adenocarcinoma, non-small cell lung cancer, and squamous cell carcinoma of the head and neck. It is being developed by GSK plc (GSK) and is currently in Phase 2 clinical development.
Lapatinib is a small molecule tyrosine kinase inhibitor that targets the HER2 and EGFR pathways. It is being evaluated in HER2-positive breast cancer, as seen in trials such as NCT00614978 for progressive brain disease in HER-2 positive breast cancer.
Lapatinib is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials of this investigational oncology drug across multiple cancer types, including breast, lung, and colorectal cancers.
Lapatinib is in Phase 2 clinical development. It has completed 17 clinical trials with a total enrollment of 4,585 patients. All trials are completed, and there are no active trials currently ongoing for this investigational drug.
Lapatinib has completed several clinical trials, including NCT00259987 in patients with relapsed adenocarcinoma of the esophagus, NCT00477464 in Japanese patients with metastatic breast cancer, and NCT00528281 in advanced non-small cell lung cancer. These trials are all completed.
Lapatinib is also known as Tykerb, as referenced in the clinical trial NCT00528281, which is titled 'A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer.' Both names refer to the same investigational drug.