SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01866410

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Trial of XL184 (Cabozantinib) Plus Erlotinib in Patients With Advanced EGFR-Mutant Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

This phase II trial studies how well cabozantinib-s-malate and erlotinib hydrochloride works in treating patients with previously treated metastatic non-small cell lung cancer. Cabozantinib-s-malate and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving cabozantinib-s-malate together with erlotinib hydrochloride may be an effective treatment for non-small cell lung cancer.

NCT01866410 Recurrent Non-Small Cell Lung Carcinoma Stage IV Non-Small Cell Lung Cancer AJCC v7
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Cabozantinib S-malate

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (cabozantinib-s-malate, erlotinib hydrochloride)

Name: Erlotinib Hydrochloride

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (cabozantinib-s-malate, erlotinib hydrochloride)

Name: Laboratory Biomarker Analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (cabozantinib-s-malate, erlotinib hydrochloride)


Primary Outcomes

Description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Measure: Objective Response Rate

Time: Up to 2 years

Secondary Outcomes

Description: Tumor doubling time was estimated using an exponential growth model. Specifically, the pre-progression scan, and the baseline scan were used to estimate the doubling time prior to enrollment, td = log(2)∗1time/1log(tumor size) [derivation, S(t) = S(to)∗2∧[(t−to)/td] for a parameterization of exponential growth with a doubling time of td. Taking the logarithm on both sides: log(S(t))-log(S(to)) = log(2)∗(t − to)/td or td = log(2)∗(t − to)/[log(S(t))-log(S(to))] = log(2)∗1time/1log(S)], the baseline scan and first evaluation scan were used to determine the doubling time. Based on pre-planned protocol assessment, we estimated the percent of patients that experienced a slowing of tumor kinetics (a 30% increase in the length of time for tumor doubling) based on RECIST v1.1 measurements. Patients who did not get a scan on study, and patients whose pre-progression scans were missing or whose pre-progression tumor size was zero or whose tumor was decreasing prior to enrollment were excluded.

Measure: Percentage of Patients With a Greater Than 30% Increase in Tumor Doubling Time

Time: Up to 2 years

Description: Grade 3 & 4 adverse events attributed to treatment agents. Events are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Measure: Number of Adverse Events

Time: Up to 2 years

Description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), ≥ 20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest diameter recorded or the appearance of one or more new lesions; Stable Disease (SD), Neither CR, PR or PD.

Measure: Best Response Patient Count

Time: Up to 2 years

Description: Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Measure: Progression-free Survival

Time: Until disease progression or death from any cause, up to 2 years

Description: Estimated using the product-limit method of Kaplan and Meier.

Measure: Overall Survival

Time: Until death from any cause, up to 2 years

Other Outcomes

Description: Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. DNA was analyzed for the presence of the T790M point mutation.

Measure: Progression-free Survival by T790M Mutation Status

Time: Until disease progression or death from any cause, up to 2 years

Description: Estimated using the product-limit method of Kaplan and Meier.

Measure: Overall Survival by T790M Mutation Status

Time: Until death from any cause, up to 2 years

Measure: Changes in VEGF Levels

Time: Baseline up to 6 months after last study treatment

Measure: Changes in HGF Levels

Time: Baseline up to 6 months after last study treatment

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

Estimated using the product-limit method of Kaplan and Meier.. Progression-free Survival by T790M Mutation Status. --- T790M ---

DNA was analyzed for the presence of the T790M point mutation.. Overall Survival by T790M Mutation Status. --- T790M ---

DNA was analyzed for the presence of the T790M point mutation.. Overall Survival by T790M Mutation Status. --- T790M --- --- T790M ---

V. Correlate outcome with tumor biomarkers such as met proto-oncogene (MET) amplification, T790M mutation, and serum markers of the vascular endothelial growth factor (VEGF) and MET pathways in a preliminary manner. --- T790M ---



HPO Nodes


HPO: