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Report for Clinical Trial NCT03244956

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation

This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation.

NCT03244956 Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
MeSH:Thyroid Neoplasms Thyroid Diseases
HPO:Abnormality of the thyroid gland Neoplasm of the thyroid gland Thyroid adenoma Thyroid carcinoma Thyroid follicular adenoma

4 Interventions

Name: Trametinib

Description: 2mg daily for a maximum of 6 weeks of treatment
Type: Drug
Group Labels: 2

patients with BRAFV600E mutation patients with RAS mutation

Name: Dabrafenib

Description: 150mg twice daily
Type: Drug
Group Labels: 1

patients with BRAFV600E mutation

Name: 131I

Description: 5.5 GBq
Type: Radiation
Group Labels: 2

patients with BRAFV600E mutation patients with RAS mutation

Name: rhTSH

Description: 0.9mg on two consecutive days after 35 days of treatment
Type: Drug
Group Labels: 2

patients with BRAFV600E mutation patients with RAS mutation


Primary Outcomes

Description: Propotion of patients with a best overall response of Complete Response (CR) or a Partial Response (PR)

Measure: Objective Response Rate (ORR)

Time: Evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed by RAI treatment in each arms

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 K601E

Inclusion Criteria: - Patients with thyroid carcinoma of follicular origin (papillary, follicular or poorly differentiated and their respective variants) - Known positive RAS (NRAS or KRAS or HRAS) or BRAFV600E or K601E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples sent for central testing or on a biopsy sample sent for central testing). --- K601E ---

- Active infection requiring systemic therapy - Active malignancy (except for DTC, or definitively treated melanoma insitu, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months - Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise subject's ability to safely complete the protocol - Females who are pregnant or breastfeeding - Patients with an injection of radio-contrast agent within 8 weeks prior enrolment - Previous history of retinal vein occlusion - Previous history of central serious retinopathy - Known hypersensitivity to the study drugs or to any of the excipients Inclusion Criteria: - Patients with thyroid carcinoma of follicular origin (papillary, follicular or poorly differentiated and their respective variants) - Known positive RAS (NRAS or KRAS or HRAS) or BRAFV600E or K601E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples sent for central testing or on a biopsy sample sent for central testing). --- K601E ---



HPO Nodes


HPO:
HP:0000820: Abnormality of the thyroid gland
Genes 475
SRD5A3 IYD IL2RG GABRA3 ATRX PAX8 IDH2 DMXL2 DUOX2 TNFSF15 GATA1 TCF4 KCNJ10 TWNK RRM2B TTC37 DCLRE1C MC2R ALX4 EXT2 PLCG2 SDHD XRCC4 GABRD FASLG TRNL1 BCL10 BUB1 NKX2-1 TSHR CHD7 FOXP3 FMR1 TSHB LHX4 SETBP1 PDE4D MST1 MALT1 MSTO1 SLC26A4 AIP CDH23 RPS20 GLIS3 BMPR1A SUFU TRNN GNAS TRNL2 PDE4D SUFU FOXP1 TBX1 PIEZO1 ND1 NRAS HBB CLCNKB COX2 EDN3 ZFAT EYA1 GCH1 EIF2AK3 EFEMP2 GLI2 TRAPPC9 PTEN PAX8 SEMA4A HABP2 UFD1 FGF8 PAX8 RNASEH2A LRBA TDGF1 B3GLCT FOXE1 LHX3 TG RET RMRP HRAS TSHR CTNS CASR NKX2-1 TRNQ HSD17B3 EDNRB CDKN2B JMJD1C SGPL1 NKX2-1 PROP1 IFNG THRB FLCN SLC5A5 THRB MLH1 POLG TSHR KCNJ18 KDM6A FUT8 CDKN1A CCBE1 IL12A LIG4 HLA-DRB1 FBLN5 TRNS1 ALMS1 DCLRE1C FOXE1 MSH3 TMEM67 CTNNB1 PAX8 TG POLG2 SEC24C SEMA3E SDHC ZIC2 TNPO3 SLC25A4 LEPR TSHR MMP2 USP9X FOXE1 LEP BIRC3 SDHB WDR4 GDNF LMNA CDKN1B LHX3 TRNL1 TBCK NNT THRA FOXI1 NNT COMT ACP5 POU1F1 SOX3 STAT1 PROKR2 GNAS VPS13A SEMA3D SOX3 TGFBR2 APC LIFR MINPP1 DISP1 CTNS THRB PROP1 SUGCT WDR11 DDOST COX1 TSHR ELN TBX1 PTEN LIG4 TXNRD2 ND5 SIX3 RAG1 ND4 TREX1 SEC23B TSHB CDKN1B RAI1 ADAT3 ELN TPO CEP57 USF3 FOXA2 RREB1 BUB3 SRY IGSF1 PDGFB CDC73 DUOXA2 DEAF1 BCOR FOXI1 PROP1 KLLN HSD17B3 KAT6B FOXP3 NSDHL DLL1 MMP14 WRN GP1BB GLI3 CEP57 BMP4 RFC2 NRTN SRGAP1 CACNA1S KISS1R PPP1R15B STAT3 ND6 CDKN2C TSHR TANGO2 HESX1 RET GPC1 STUB1 HNF1B AKT1 DICER1 TRNF NODAL SLC26A4 DNAJC19 PMM2 DICER1 CTLA4 PRDM16 ITCH GLI2 GNE SKI POLR1D KCNAB2 INSR SLC12A3 ENPP1 WFS1 GLI3 LIMK1 MRAP PTEN TBL2 RNASEH2B TWNK TGIF1 NKX2-5 ZBTB20 POMC TSHR PTEN YY1 DNM1L RERE NKX2-5 MARS1 SCN4A MSH3 ABCC6 IL7R GATA6 GREM1 PRKAR1A ADAMTSL1 POU3F4 EXOSC2 SLC6A17 LEPR KEAP1 CHD7 FUCA1 WFS1 APC IFIH1 HIRA RAI1 AFF4 PIK3C2A RBM28 FGFR1 ARNT2 KMT2D POU2AF1 SMARCB1 CLIP2 SEC23B CACNA1S ALG8 CP MEN1 TPO PPP1R15B PLVAP FAS SIX1 GNAS FANCI BUB1B RET DACT1 HABP2 C1QBP PTRH2 ADAR GAS1 ADA STAT1 SHH STAR IL12RB1 IRF5 FOXH1 TBC1D24 BMPR1A MINPP1 TRHR NKX2-5 POLR1C TRH DNAH1 PMS1 NKX2-1 PIK3CA RAG2 PCSK1 FDX2 GNAS FOXE1 MSTO1 RAI1 MSH6 TF TBX2 FLII FOXE1 TONSL APC STEAP3 BRAF PIK3CA SKIV2L TG HPD POLG LHX4 PROP1 PIK3CA EPCAM FOXD3 TRNS1 KCNJ18 MEN1 IQSEC2 SAA1 KRAS SLC5A5 KAT6B DUOX2 TRIP13 UBR1 SLC26A4 TSC2 IGH AKT1 USP9X ALMS1 PMS2 RCBTB1 APC HBB RASGRP1 CASP10 ROBO1 POU1F1 NPHS1 DMXL2 CDC73 ARVCF GTF2I DUOXA2 TRNW COX3 LHX4 POLR3A PLAA IL2RA CDON PRKAR1A HNF4A RNASEH2C JAG1 BTNL2 TRNH OPA1 DICER1 KIAA0556 NLRP1 TCOF1 APOE GPR35 TBX1 SLC16A2 PRKCD AIRE KCNJ10 HESX1 TRNS2 MLXIPL SAMHD1 TRMT10A LIG4 SEMA3C FMR1 CDH23 TANGO2 TSHR FLCN PTCH1 HESX1 BAZ1B FAN1 CDC73 POU1F1 GPR161 C1S IYD PHF21A MEN1 IDH1 LRP4 DUOX2 RET APC CACNA1C SASH1 PTEN TTC7A OTX2 MSH2 ECE1 APC TRNW MMEL1 SALL1 MCM8 XRCC4 DCAF17 FAS MLH3 SALL1 FOXP1 SPIB NF2 CLPB CDON LHX4 NIN ARL6IP6 GTF2IRD1 SLC26A4 TSC1 PRKAR1A
Protein Mutations 4
F11N K601E V600E V600K
SNP 0