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Report for Clinical Trial NCT02274012

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment of HER2 Amplified Advanced Gastric, Gastroesophageal Junction and Esophageal Cancer

The investigators are doing this research program to find out if the investigational drug, afatinib which is a medication known to block the function of the ErbB2 protein might help standard chemotherapy, in particular paclitaxel, work better. Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2. On July 12, 2013 the United States Food and Drug Administration (US FDA) approved afatinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors had specific EGFR gene mutations (exon 19 deletions or exon 21 i.e. L858R substitution mutations) as detected by an FDA approved test. Paclitaxel is a standard, anti-cancer medicine that has been approved by the US Food and Drug Administration (FDA) for the treatment of lung cancer. The combination of Afatinib and Paclitaxel are considered investigational when used in this research program. An investigational drug is a drug that is not approved by the FDA for its indication.

NCT02274012 HER-2 Positive Gastric Cancer Gastrooesophageal Cancer Esophageal Cancer
MeSH:Esophageal Neoplasms
HPO:Esophageal neoplasm

2 Interventions

Name: Afatinib

Description: Afatinib 40mg/PO daily will be administered in combination to standard of care paclitaxel.
Type: Drug
Group Labels: 1

Afatinib and weekly Paclitaxel

Name: Paclitaxel

Description: On the day of the first dose of afatinib, paclitaxel will be administered at a dose of 80 mg/m2 intravenously over 60 minutes on days 1, 8 and 15 of a 28-day cycle.
Type: Drug
Group Labels: 2

Afatinib and weekly Paclita Afatinib and weekly Paclitaxel


Primary Outcomes

Measure: Change of tumor burden (in centimeters) for participants during protocol therapy

Time: Change from Baseline Tumor burden, measured every 8 weeks, up to approximately 4 years

Secondary Outcomes

Description: Safety of BIBW 2992 will be evaluated as indicated by intensity and incidence of adverse events, graded according to US National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0. Safety endpoints include: events leading to dose reduction events leading to permanent treatment discontinuation the overall incidence and CTC criteria grade of adverse events, as well as relatedness of adverse events to treatment causes of death

Measure: Number of participants with adverse events.

Time: up to approximately 36 months

Description: CTC number changes from cycle 1, day 1 to cycle 2/3, day 1 will be correlated with response rate, progression-free survival as well as skin toxicity.

Measure: Total number of circulating tumor cell (CTC) numbers.

Time: up to approximately 36 months

Measure: Clinical benefit in progression free survival.

Time: every 3 months up to approximately 4 years

Measure: Clinical benefit in overall survival.

Time: every 3 months up to approximately 4 years

Description: Diagnostic tumor specimens will be retrieved for all subjects participating in the protocol. These specimens will be used for confirmation of ErbB2 status as well as correlative analyses of clinical response.

Measure: ErbB2 levels benefit during therapy.

Time: up to approximately 4 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

L858R substitution mutations) as detected by an FDA approved test. --- L858R ---



HPO Nodes


HPO: