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Report for Clinical Trial NCT02489903

Developed by Shray Alag, 2020.
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 Carcinoma, Ovarian Epithelial Neuroendocrine Tumors Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Small Cell Lung Carcinoma
HPO: Carcinoma Neuroendocrine neoplasm Non-small cell lung carcinoma Small cell lung carcinoma

12 Interventions

Name: RRx-001

Type: Drug

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

Name: Cisplatin

Type: Drug

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

Name: Etoposide

Type: Drug

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

Name: Carboplatin

Type: Drug

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

Name: Irinotecan

Type: Drug

Small Cell Lung Cancer (Arm 2)

Name: Vinorelbine

Type: Drug

Ovarian epithelial cancer (Arm 2) Small Cell Lung 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 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
Neuroendocrine neoplasm
Genes 62
CCND1 SDHB SDHC MEN1 VHL ATRX DAXX DNMT3A APC SDHAF2 SDHC SDHD CDKN1B SDHD MAX GCGR CDKN1B SDHB SDHD APC TMEM127 MEN1 RET SLC25A11 SDHB SDHD KIF1B MAX VHL SDHD SDHAF2 RET CDKN2B SDHC FH PRKAR1A TMEM127 DLST CDKN2C VHL SLC25A11 RET GDNF SDHC SDHA MAFA KIF1B SDHD MEN1 CDKN1A VHL LMNA DLST RET PRKAR1A SDHA CDKN1B MDH2 SDHB NF1 SDHB APC
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1
Small cell lung carcinoma