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Tykerb Medical Research Studies

Up-to-date List of Tykerb Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Tykerb Medical Research Studies

Rank Status Study
1 Recruiting Regulatory Tykerb PMS
Condition: Cancer
Intervention: Drug: Tykerb
Outcome Measures: Occurrence of adverse events after Tykerb® administration;   Occurrence of unexpected or serious adverse event after Tykerb® administration and effectiveness of Tykerb®
2 Recruiting Lapatinib With Sirolimus or Metformin
Condition: Advanced Cancers
Interventions: Drug: Lapatinib;   Drug: Sirolimus;   Drug: Metformin
Outcome Measure: Maximum Tolerated Dose (MTD) of Lapatinib
3 Recruiting A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval
Condition: Cancer
Interventions: Drug: lapatinib;   Drug: placebo matching lapatinib
Outcome Measures: • The primary enpoint will be the change in baseline adjusted QTcF interval at each time point for lapatinib (average of at least 3 Holter ECG replicates per time point) as compared with time-matched placebo;   • ECG parameters: RR interval, QT, QTcB, QTci, heart rate, PR, QRS intervals and morphology;   • Plasma lapatinib concentrations and pharmacokinetic parameters AUC(0-t), AUC(0-24), C24, Cmax, tlag, and tmax;   • Safety parameters: AEs, vital signs, ECGs and clinical laboratory assessments
4 Recruiting Concentration and Activity of Lapatinib in Vestibular Schwannomas
Conditions: Vestibular Schwannoma;   NF2;   Neurofibromatosis 2;   Acoustic Neuroma;   Auditory Tumor
Intervention: Drug: lapatinib
Outcome Measures: To assess steady-state lapatinib plasma concentrations at the time of surgical resection, 10 (+3) days after oral dosing.;   To assess whether lapatinib can reach a minimum tumor concentration level of >3uM in VS after oral dosing.;   Assess the level of ErbB2 and EGFR phosphorylation and activity of downstream signaling effectors in VS.;   Assess markers of tumor proliferation and cell death in VS after exposure to lapatinib.;   Explore the difference in the concentration of lapatinib achieved in NF2-related versus idiopathic VS.;   Perform NF2 gene mutation analysis via exon scanning and MLPA as well as protein expression in all VS and explore differences between sporadic and NF2 related VS.
5 Recruiting Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel
Condition: Breast Cancer
Interventions: Drug: Trastuzumab Emtansine;   Drug: Trastuzumab;   Drug: Lapatinib;   Drug: Abraxane;   Drug: Paclitaxel
Outcome Measures: pathological complete response rate (pCR);   Clinical Response Rate;   breast imaging response to treatment;   objective response rate;   toxicity, safety and efficacy of study treatment
6 Recruiting A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
Condition: Neoplasms, Breast
Interventions: Drug: lapatinib;   Drug: trastuzumab;   Drug: Aromatase inhibitor
Outcome Measures: Overall survival of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination;   Overall survival of trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs. lapatinib/AI;   Progression free survival (PFS) of lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI;   Overall response rate (complete or partial response), time to response, and duration of response in lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI;   Clinical benefit (complete response, partial response, or stable disease for at least 6 months) of lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI;   Safety and tolerability of all three treatment groups (lapatinib/ trastuzumab/ AI, trastuzumab/ AI, or lapatinib/AI);   Changes in the quality of life (QoL) status relative to baseline of lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI;   The identification of tumor-derived biomarkers (DNA, RNA and protein) associated with clinical outcome;   The evaluation of biomarkers known to predict sensitivity or resistance to lapatinib and trastuzumab (e.g. p95HER2, PIK3CA mutations, PTEN aberrations and other markers associated with these pathways) and determine the relationship with clinical outcom;   The examination of pre and post treatment circulating free DNA (cfDNA) to determine whether mutations (e.g., PI3KCA) in cfDNA correlate with that in the tumor tissue from which it is derived;   Dependent on study outcomes, exploratory research may be conducted to identify genetic markers in patient DNA that are associated with response to study drugs.
7 Recruiting Study of How Well Letrozole Works in Combination With Lapatinib Followed by an Addition of Everolimus in Postmenopausal Women With Advanced Endocrine Resistant Breast Cancer
Conditions: Breast Neoplasms;   Endocrine Breast Diseases;   Neoplasm Metastasis
Interventions: Drug: letrozole;   Drug: lapatinib;   Drug: everolimus
Outcome Measures: Clinical benefit rate of patients treated with the combination of letrozole and lapatinib and then after progression, treated with everolimus, letrozole and lapatinib.;   Assess the progression free survival (PFS) of patients treated with the combination of letrozole and lapatinib.;   Assess the progression free survival (PFS) when adding everolimus to the combination of letrozole and lapatinib upon progression.
8 Recruiting Lapatinib Tosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma
Conditions: Adult Anaplastic Astrocytoma;   Adult Anaplastic Ependymoma;   Adult Anaplastic Oligodendroglioma;   Adult Giant Cell Glioblastoma;   Adult Glioblastoma;   Adult Gliosarcoma;   Adult Mixed Glioma;   Recurrent Adult Brain Tumor
Interventions: Drug: lapatinib ditosylate;   Procedure: therapeutic conventional surgery;   Other: pharmacological study;   Other: laboratory biomarker analysis
Outcome Measures: Lapatinib ditosylate intratumoral concentration (pharmacokinetics);   Ratio of phosphorylated (p)EGFR/total EGFR (PD) in tumor tissue;   Incidence of adverse events (AEs);   Inhibition of tumor cell proliferation (KI-67);   Ex-vivo sensitivity of tumor sphere cultures to lapatinib ditosylate
9 Recruiting Entinostat, Lapatinib Ditosylate and Trastuzumab in Treating Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab Only
Conditions: HER2-positive Breast Cancer;   Male Breast Cancer;   Recurrent Breast Cancer;   Stage IV Breast Cancer
Interventions: Drug: entinostat;   Drug: lapatinib ditosylate;   Biological: trastuzumab;   Other: laboratory biomarker analysis
Outcome Measures: RP2D for entinostat in combination with lapatinib ditosylate defined as the highest dose level in which 6 patients have been treated with at most 1 patient experiencing dose limiting toxicity (DLT);   Incidence of grade III or IV adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4;   Changes in phosphorylated HER2 levels before and after the combination treatment of entinostat, lapatinib and trastuzumab
10 Recruiting Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors
Conditions: Bladder Cancer;   Brain and Central Nervous System Tumors;   Breast Cancer;   Esophageal Cancer;   Extragonadal Germ Cell Tumor;   Gastric Cancer;   Lung Cancer;   Ovarian Cancer;   Prostate Cancer
Interventions: Drug: lapatinib;   Drug: paclitaxel
Outcome Measures: Maximum tolerated dose (MTD) of lapatinib in course 1;   Toxicity;   Anti-tumor efficacy and safety every 8 weeks;   Pharmacokinetics during the first 2 weeks of treatment
11 Recruiting Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab
Condition: Metastatic Breast Cancer
Interventions: Drug: Lapatinib;   Drug: Vinorelbine
Outcome Measures: Progression free survival rate at 18 weeks;   Progression free survival (PFS);   Overall survival (OS);   toxicity;   response rate
12 Recruiting Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents
Condition: Neoplasms, Breast
Interventions: Drug: Lapatinib in combination with an anti-cancer agent;   Drug: Lapatinib;   Drug: Lapatinib in combination with an anti-cancer agent as specified by parent protocol
Outcome Measures: Safety and tolerability;   Efficacy
13 Recruiting Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer
Conditions: Male Breast Cancer;   Recurrent Breast Cancer;   Stage IIIA Breast Cancer;   Stage IIIB Breast Cancer;   Stage IIIC Breast Cancer
Interventions: Drug: lapatinib ditosylate;   Radiation: radiation therapy;   Other: laboratory biomarker analysis
Outcome Measures: Percentage of patients achieving complete clinical response;   Feasibility of assessing the effects of lapatinib and radiation therapy on BCSCs using flow cytometry and SCGEP;   Change in the proportion of BCSCs;   Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0;   Pathologic complete response rate for those patients undergoing surgical resection defined as no evidence of residual tumor in the breast and lymph nodes
14 Recruiting Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases
Condition: Metastatic Breast Cancer With Intracranial Metastases
Interventions: Drug: cabazitaxel;   Drug: lapatinib
Outcome Measures: Central Nervous System (CNS) response rate;   Number of patients with grade 3/4 adverse events as a measure of safety.;   Clinical benefit rate (CNS metastases);   CNS progression free survival rate;   Extra-cranial response rate;   Clinical benefit rate (extracranial disease)
15 Recruiting Dabrafenib and Lapatinib Ditosylate in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed By Surgery
Condition: Recurrent Thyroid Cancer
Interventions: Drug: lapatinib ditosylate;   Drug: dabrafenib;   Other: pharmacological study;   Other: laboratory biomarker analysis
Outcome Measures: Maximum tolerated dose of lapatinib ditosylate, in combination with the established dose of dabrafenib, defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity;   Mean percent change in the post-treatment tissues relative to pre-treatment tissues for the phosphorylated protein targets examined;   Mean percentage change in transcript levels in the post-treatment tissues relative to pre-treatment tissues for several genes analyzed by reverse-transcriptase-polymerase chain reaction
16 Recruiting Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer
Condition: ErbB2-Positive Stage I-III Breast Cancer
Intervention: Drug: paclitaxel/carboplatin/lapatinib
Outcome Measures: Rate of pathologic complete response;   Treatment related toxicities;   Breast conservation rates;   Clinical response rates;   Relapse free survival (RFS);   Identification of tumor biomarkers that predict pathologic complete response
17 Recruiting Lapatinib and RAD-001 for HER2 Positive Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
Intervention: Drug: Lapatinib and RAD-001
Outcome Measures: Assess the effectiveness of the combination of RAD-001 and lapatinib;   Overall benefit of combination
18 Unknown  The Treatment of Lapatinib in Combination With Sorafenib in Patients With Advanced Refractory Solid Tumors
Condition: Solid Tumors
Intervention: Drug: Lapatinib and Sorafenib
Outcome Measures: To determine the dose limiting toxicities (DLTs)and the maximum tolerated dose (MTD) of the combination of Lapatinib and Sorafenib.;   To determine the safety profile of escalating doses of Lapatinib in combination with escalating doses of Sorafenib and and to compare the pharmacokinetics of Lapatinib alone and in combination with Sorafenib
19 Recruiting Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
Intervention: Drug: lapatinib plus oral vinorelbine
Outcome Measures: To determine the recommended dose of the combination of oral lapatinib with vinorelbine (phase I part), and progression free survival (phase II part);   response rate, safety profile
20 Recruiting Efficacy and Tolerability of Eribulin Plus Lapatinib in Patients With Metastatic Breast Cancer (E-VITA)
Condition: Metastatic Breast Cancer
Interventions: Drug: Lapatinib + 1,23 mg Eribulin;   Drug: Lapatinib + 1,76 mg Eribulin
Outcome Measures: Time to Progression (TTP);   Safety of the Therapy;   Toxicity of Therapy;   Objective Response Rate;   Overall Clinical Benefit Rate;   Overall Survival;   Assess PI3K mutation, PTEN expression and c-myc (Biomarkers) on primary tumor

These studies may lead to new treatments and are adding insight into Tykerb etiology and treatment.

A major focus of Tykerb research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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