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RASTRIC-trial: onderzoek naar de veiligheid en effectiviteit van een nieuwe behandeling met drie middelen voor patiënten met uitgezaaide dikkedarmkanker met een RAS-mutatie.

ABSTRACT: Interventions: lapatinib + binimetinib + vinorelbine Primary Objective: Phase I dose escalation The main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination. Phase II The main objective of the phase II part is to determine efficacy of the triplet combination defined by objective response rate according to RECIST 1.1. Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Other

DISEASE(S): Metastatic Colorectal Cancer With A Proven Ras Mutation

PROVIDER: 2443226 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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RASTRIC-trial: investigating the safety and efficacy of a new three drug treatment combination for RAS-mutated metastastic colorectal cancer.

Project description:Primary objectives: Phase I The main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination. Phase II The main objective of the phase II part is to determine efficacy of the triplet combination defined by objective response rate according to RECIST 1.1. Primary endpoints: For the phase I dose-escalation trial: The primary endpoint is the incidence of DLTs leading to a RP2D. The RP2D of the triplet will be the MTD which is defined as the dose level that can be given to 6 subjects such that not more than 1 subject experiences a DLT. For the phase II trial: The primary endpoint is best overall response (OR), defined as complete response (CR) + partial response (PR) within 6 months, based on RECIST 1.1.

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Optimalisatie van de behandeling van uitgezaaide darmkanker met cetuximab middels opname metingen van 89Zr gelabeld cetuximab mbv PET.

Project description:Interventions: Patients will be treated with cetuximab. For pharmacodynamic purposes PET-imaging with 89Zr-labelled cetuximab will be performed. In addition, two [18F-]-FDG PET-CT will be performed to explore early response. Patients will undergo blood sampling and two skin biopsies for pharmacodynamic purposes of 89Zr-labelled cetuximab and kinase activity profiles, respectively. Primary outcome(s): To demonstrate uptake of 89Zr-cetuximab in non-hepatic tumor lesions using immuno-PET when administered during the loading dose of cetuximab. Part two - Primary objective: To investigate whether there is an association between uptake of cetuximab in non-hepatic tumor lesions and response according to RECIST 1.1 criteria. Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Parallel

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Preclinical and phase I clinical studies of KW-2450, a dual IGF-1R/IR tyrosine kinase inhibitor, in combination with lapatinib and letrozole.

Project description:KW-2450 is an oral dual insulin-like growth factor-1 receptor/insulin receptor tyrosine kinase inhibitor. We investigated the in vitro and in vivo preclinical activity of KW-2450 plus lapatinib and letrozole and conducted a phase I trial of the triple-drug combination in one male and 10 postmenopausal female patients with advanced/metastatic hormone receptorpositive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer. A series of in vitro and in vivo animal studies was undertaken of KW-2450 in combination with lapatinib and hormonal agents. The phase I trial was conducted to establish the safety, tolerability, and recommended phase II dose (RP2D) of KW-2450 administered in combination with lapatinib and letrozole. Preclinical studies showed KW-2450 and lapatinib act synergistically to induce in vitro apoptosis and inhibit growth of HER2-positive MDA-MB-361 and BT-474 breast cancer cell lines. This combined effect was confirmed in vivo using the MDA-MB-361 xenograft model. KW-2450 showed synergistic in vitro growth inhibition with letrozole and 4-hydroxytamoxifen in ER-positive MCF-7 breast cancer cells and MCF-7-Ac1 aromatase-transfected MCF-7 cells. In the phase I study, dose-limiting toxicity (DLT; grade 3 rash and grade 3 hyperglycemia, respectively) occurred in two of three patients at the dose of KW-2450 25 mg/day plus lapatinib 1500 mg/day and letrozole 2.5 mg/day. The RP2D of the triple-drug combination was established as KW-2450 25 mg/day, lapatinib 1250 mg/day, and letrozole 2.5 mg/day with no DLT at this dose level.

2018-08-26 | GSE82161 | GEO

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Project description:This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.

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Homo sapiens

Project description:TBCRC003: Phase II Study of Trastuzumab & Lapatinib in Metastatic HER + Breast Cancer

| PRJNA288245 | ENA

TBCRC003: Phase II Study of Trastuzumab & Lapatinib in Metastatic HER + Breast Cancer

Project description:TBCRC003: Phase II Study of Trastuzumab & Lapatinib in Metastatic HER + Breast Cancer

| PRJNA288244 | ENA

Prospective biomarker analysis of the randomized CHER-LOB study evaluating the dual anti-HER2 treatment with chemotherapy plus trastuzumab and lapatinib as neoadjuvant therapy for HER2-positive breast cancer [expression]

Project description:The CHER-LOB randomized phase II study showed that the combination of lapatinib and trastuzumab plus chemotherapy increases the pathologic complete remission (pCR) rate as compared to chemotherapy plus either trastuzumab or lapatinib. An extensive biomarker programme was prospectively planned to identify potential predictors of sensitivity to different treatments and evaluate treatment effect on tumor biomarkers. A mutation in PIK3CA exon 20 or 9 was documented in 20% of the cases. Overall, the pCR rates were similar in PIK3CA wild type and PIK3CA mutated patients (33.3% vs 22.7%; p=0.323). However, for patients receiving trastuzumab plus lapatinib, the probability of pCR was higher in PIK3CA wild type tumors (48.4% vs 12.5%; p=0.06). Ki67, pAKT and apoptosis measured on the residual disease were significantly reduced from baseline. The degree of Ki67 inhibition was significantly higher in patients receiving the dual anti-HER2 blockade. In conclusion, PIK3CA mutations seem to identify patients less likely to benefit from dual anti-HER2 inhibition. p95-HER2 and markers of PI3K pathway deregulation are not confirmed as markers of different sensitivity to trastuzumab or lapatinib.

2015-10-06 | GSE66305 | GEO

2015-10-06 | GSE66398 | GEO

Randomized Phase III Trial of Neoadjuvant HER2 Therapy in Breast Cancer

Project description:<p>This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.</p>

| phs001570 | dbGaP

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Project description:Our main objective was to study the changes in cDNA microarray gene expression profiles of A. thaliana plants exposed to different doses of a polymetallic solution containing Pb (II), Hg (II), Cu (II), Cd (II), Co (II), Ni (II), Zn (II) and Mn (II) over 3 hours. Control plants grown in the absence of metals were also included in the experiment.

2014-09-30 | E-MTAB-2835 | biostudies-arrayexpress

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