SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01074177

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Understanding Mechanisms of Acquired Resistance to BIBW2992

In this research study we are looking to see how effective BIBW 2992 is at suppressing the development of the T790M mutation in non-small cell lung cancer (NSCLC) patients. Epidermal growth factor receptors (EGFR) are proteins found on the surface of some cancer cells that promote a growth signal. Some cancer drugs for NSCLC work to block this signal from reaching its target on the cancer cells which in turn may slow or stop the cancer from growing. However, many times patients with EGFR mutations will stop responding to these cancer drugs and develop drug-resistance because they have developed a specific EGFR mutation called T790M. BIBW 2992 may prevent the T790M mutation from becoming active and therefore slow disease progression.

NCT01074177 Non-small Cell Lung Cancer EGFR Mutations
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: BIBW 2992

Description: Taken orally once a day

Type: Drug

BIBW 2992


Primary Outcomes

Measure: Number of Participants That Have a T790M Mutation on Their Progression Biopsy.

Time: At the time of disease progression (median duration of 11.4 months from start of treatment)

Secondary Outcomes

Description: The number of participants with either a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) CR: Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Measure: Response Rate

Time: Baseline and then after the end of every two 28 day cycles until treatment is discontinued; median duration of followup of 19.3 months

Description: The progression-free and overall survival times. Overall survival is measured from the start of treatment until the time of death or until the participant is lost to follow-up. Progression free survival is measured from the start of treatment until the time of progression, death, or until the participant is lost to follow-up (whichever occurs first). Progression is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.

Measure: Median Progression-free and Overall Survival

Time: start of treatment, at the time of disease progression, time of death

Description: The number of participants with biopsy complications from repeat tumor biopsies taken following disease progression. Biopsy complications are any adverse events considered to be potentially related to the biopsy.

Measure: Number of Participants With Biopsy Complications From Repeat Tumor Biopsies

Time: 7 days post biopsy and ≥ 30 days post-biopsy

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

Understanding Mechanisms of Acquired Resistance to BIBW2992 In this research study we are looking to see how effective BIBW 2992 is at suppressing the development of the T790M mutation in non-small cell lung cancer (NSCLC) patients. --- T790M ---

However, many times patients with EGFR mutations will stop responding to these cancer drugs and develop drug-resistance because they have developed a specific EGFR mutation called T790M. --- T790M ---

BIBW 2992 may prevent the T790M mutation from becoming active and therefore slow disease progression. --- T790M ---

Number of Participants That Have a T790M Mutation on Their Progression Biopsy.. null. --- T790M ---

The purpose of this biopsy is to assess for the presence or the absence of the mutation T790M. --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1