SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01560104
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
A Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin
and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated
Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC).
Name: Veliparib
Type: Drug
veliparib and carboplatin and paclitaxel
Name: Carboplatin
Type: Drug
veliparib and carboplatin and paclitaxel placebo and carboplatin and paclitaxel
Name: paclitaxel
Type: Drug
veliparib and carboplatin and paclitaxel placebo and carboplatin and paclitaxel
Name: placebo
Type: Drug
placebo and carboplatin and paclitaxel
Primary Outcomes
Measure: Progression Free Survival (PFS)
Time: Radiographic evaluation starting from the third day of study treatment and on average every 6 weeks until documented progression or date of death from any cause, whichever came first, until patient is registered as off study.
Secondary Outcomes
Description: Continuously from date of randomization until date of death from any cause or until patient is registered as off study, whichever came first.
Measure: Overall Survival (OS)
Time: Monthly after patient is registered off study up to 36 months or until date of death from any cause, whichever came first.
Measure: Objective Response Rate (ORR)
Time: Radiographic evaluation starting from the third day of study treatment and on average every 6 weeks until documented progression or date of death from any cause, whichever came first, until patient is registered as off study.
Measure: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Time: From date of screening, first day of study treatment and then every cycle (about every 3 weeks) until date of death from any cause or patient is registered as off study, whichever came first.
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 L858R
- Subjects with peripheral neuropathy ≥ grade 2.
- Subjects with a known epidermal growth factor receptor (EGFR) mutation of exon 19
deletion or L858R mutation in exon 21. (Subjects with wild type epidermal growth
factor receptor (EGFR), unknown status or other type of epidermal growth factor
receptor (EGFR) mutation will be considered eligible). --- L858R ---
HPO Nodes
HPO: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 hr>Non-small cell lung carcinoma
Genes 2
TP53 BAP1 hr>