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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
Group Labels: 5

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

Name: Cisplatin

Type: Drug
Group Labels: 4

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

Name: Etoposide

Type: Drug
Group Labels: 4

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

Name: Carboplatin

Type: Drug
Group Labels: 6

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
Group Labels: 1

Small Cell Lung Cancer (Arm 2)

Name: Vinorelbine

Type: Drug
Group Labels: 2

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

Name: Doxil

Type: Drug
Group Labels: 1

Ovarian epithelial cancer (Arm 2)

Name: Gemcitabine

Type: Drug
Group Labels: 1

Ovarian epithelial cancer (Arm 2)

Name: Taxane

Type: Drug
Group Labels: 1

Ovarian epithelial cancer (Arm 2)

Name: Paclitaxel

Type: Drug
Group Labels: 1

Non Small Cell Lung Cancer

Name: Nab-Paclitaxel

Type: Drug
Group Labels: 1

Non Small Cell Lung Cancer

Name: Pemetrexed

Type: Drug
Group Labels: 1

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


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