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Report for Clinical Trial NCT02220855

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas

Thymic tumors are rare tumors, but represent the most common tumors of the anterior mediastinum. Thymoma has an indolent course in advanced disease and has the propensity to spread to the pleura. In first line therapy, combination chemotherapy produces responses in approximately 80% of patients. A number of single agents have activity in recurrent disease, but none are curable. Patients with recurrent thymoma have limited treatment options, and thus novel target modalities are needed. At the Indiana University Simon Cancer Center (IUSCC), more patients with advance thymoma are seen than any other institution in the country. Our main hypothesis is the PI3K pathway is an important driver for growth and metastasis of thymoma and that inhibition of the PI3K pathway is expected to produce clinically meaningful response in patients with recurrent thymoma.

NCT02220855 Thymoma
MeSH:Thymoma Thymus Neoplasms
HPO:Neoplasm of the thymus Thymoma

1 Interventions

Name: BKM120

Type: Drug
Group Labels: 1

BKM120


Primary Outcomes

Description: Percent of patients with Objective response and the Binomial Exact 95% confidence interval. Objective response is defined as having a best response of Complete Response (defined as disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10mm) or Partial Response (defined as at least a 30% decrease in the sum of diameters of target lesions from the baseline sum diameters) by RECIST v1.1 criteria.

Measure: Percent of Patients With Objective Response

Time: up to three years

Secondary Outcomes

Description: Number of unique patients who had a treatment related (possible, probable or definite) adverse events with grade >= 3.

Measure: Treatment Related Adverse Events Grade 3 or Above

Time: up to three years

Description: Duration of time from the start of treatment to time of documented progression or death. Patients who do not progress or die will be censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.

Measure: Progression-free Survival Rate

Time: up to three years

Description: Percent of patients achieving disease control and the Binomial Exact 95% confidence interval. Disease control is defined as having a best response of Complete Response (defined as disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10mm) or Partial Response (defined as at least a 30% decrease in the sum of diameters of target lesions from the baseline sum diameters) or Stable Disease for at least 4 months (defined by neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression) by RECIST v1.1 criteria.

Measure: Percent of Patients Achieving Disease Control

Time: up to three years

Description: Duration of time from the start of treatment to time of death due to any causes. Patients who do not die will be censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.

Measure: Overall Survival Rate

Time: up to three years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 P13K

Signed informed consent 22. INR ≤ 2 Exclusion Criteria: 1. Patients who have received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes


HPO: