Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lapatinib and Capecitabine · 2 trials · 1 indication
DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting \>=7 days, thrombocytopenia (\<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of \>5 days, for Days 8 or 15 of weekly paclitaxel.
OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.
Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.
Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as \>= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.
5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of \>=1 NL and/or unequivocal progression of existing non-TLs, and a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.
| Arm | Type | Description |
|---|---|---|
| Paclitaxel plus Lapatinib | EXPERIMENTAL | 6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly |
| Paclitaxel alone | ACTIVE_COMPARATOR | Infusion of paclitaxel at 80 mglm2 weekly |
| Name | Type | Description |
|---|---|---|
| Lapatinib | DRUG | 6 pills at 250 mg each once daily |
| Paclitaxel | DRUG | Infusion at 80 mg/m2 weekly |
| Lapatinib and Capecitabine | DRUG | oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine |
Inclusion criteria: Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator's Brochure (IB) Pilot Part Subjects eligible for enrollmen...
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.