SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02489903

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II Study of RRx-001 in Platinum Refractory/Resistant Small Cell Carcinoma, EGFR TKI Resistant EGFR+ T790M Negative Non-Small Cell Lung Cancer, High Grade Neuroendocrine Tumors and Resistant/Refractory Ovarian Cancer Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)

This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy.

NCT02489903 Small Cell Carcinoma Carcinoma, Non-Small-Cell Lung Neuroendocrine Tumors Ovarian Epithelial Cancer
MeSH: Carcinoma Lung Neoplasms Ovarian Neoplasms Carcinoma, Ovarian Epithelial Neuroendocrine Tumors Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Small Cell Lung Carcinoma
HPO: Carcinoma Neoplasm of the lung Neuroendocrine neoplasm Non-small cell lung carcinoma Ovarian neoplasm Small cell lung carcinoma

12 Interventions

Name: RRx-001

Type: Drug

Small Cell Lung Cancer (Arm 1) Non Small Cell Lung Cancer Neuroendocrine tumors Ovarian epithelial cancer (Arm 1)

Name: Cisplatin

Type: Drug

Small Cell Lung Cancer (Arm 1) Small Cell Lung Cancer (Arm 2) Non Small Cell Lung Cancer Neuroendocrine tumors

Name: Etoposide

Type: Drug

Small Cell Lung Cancer (Arm 1) Small Cell Lung Cancer (Arm 2) Neuroendocrine tumors Ovarian epithelial cancer (Arm 2)

Name: Carboplatin

Type: Drug

Small Cell Lung Cancer (Arm 1) Small Cell Lung Cancer (Arm 2) Non Small Cell Lung Cancer Neuroendocrine tumors Ovarian epithelial cancer (Arm 1) Ovarian epithelial cancer (Arm 2)

Name: Irinotecan

Type: Drug

Small Cell Lung Cancer (Arm 2)

Name: Vinorelbine

Type: Drug

Small Cell Lung Cancer (Arm 2) Ovarian epithelial cancer (Arm 2)

Name: Doxil

Type: Drug

Ovarian epithelial cancer (Arm 2)

Name: Gemcitabine

Type: Drug

Ovarian epithelial cancer (Arm 2)

Name: Taxane

Type: Drug

Ovarian epithelial cancer (Arm 2)

Name: Paclitaxel

Type: Drug

Non Small Cell Lung Cancer

Name: Nab-Paclitaxel

Type: Drug

Non Small Cell Lung Cancer

Name: Pemetrexed

Type: Drug

Non Small Cell Lung Cancer


Primary Outcomes

Description: the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.

Measure: Overall Survival

Time: up to one year

Secondary Outcomes

Description: The proportion of patients who achieve a reduction in the sum of target lesions by 30% following the re-administration of chemotherapy. Radiographic assessment of disease burden will be evaluated by CT and disease RR will be documented using RECIST v1.1.

Measure: Overall Response Rate (ORR)

Time: 12 weeks

Description: The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1).

Measure: Disease Control Rate (DCR)

Time: 12weeks

Description: the time from enrollment to the time of the first radiographic documentation of objective progression as defined by RECIST v1.1 or death from any cause.

Measure: Progression Free Survival (PFS)

Time: 12 weeks

Measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of platinum doublet therapy post RRx-001

Time: 12 weeks

Measure: Changes in the level of serum biomarkers will be calculated and treatment samples will be compared to baseline samples using one-sample tests (e.g., paired t test or Wilcoxon signed rank test).

Time: 12 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

A Phase II Study of RRx-001 in Platinum Refractory/Resistant Small Cell Carcinoma, EGFR TKI Resistant EGFR+ T790M Negative Non-Small Cell Lung Cancer, High Grade Neuroendocrine Tumors and Resistant/Refractory Ovarian Cancer Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT). --- T790M ---



HPO Nodes


HPO:
Carcinoma
Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Neuroendocrine neoplasm
Genes 25
CDKN1A CDKN1B APC VHL PRKAR1A CDKN2B CDKN2C DAXX GCGR NF1 RET FH MDH2 LMNA ATRX SDHAF2 TMEM127 MAX SDHA SDHB SDHC KIF1B SDHD MAFA MEN1
Non-small cell lung carcinoma
Genes 2
TP53 BAP1
Ovarian neoplasm
Genes 63
RAD51 RAD51C PMS1 RAD51D CDKN2A KRAS SOX9 TGFBR2 FLI1 MRE11 MSH6 PMS2 MLH3 BRIP1 DMRT3 WWOX BRCA1 LMNA BRCA2 INHBA PIK3CA VAMP7 NR0B1 WRN CHEK2 GATA4 WT1 PTCH2 BARD1 MLH1 WNT10A NBN AKT1 C11ORF95 PRKN SRY EWSR1 RELA NR5A1 MSH2 MSH3 FGFR2 KEAP1 IDH1 IDH2 CTNNB1 PTCH1 PTEN SUFU CDH1 EPCAM DICER1 STAG3 RNF43 PALLD PALB2 OPCML TP53 MAP3K1 ZFPM2 SMAD4 FAN1 RAD50
Small cell lung carcinoma