SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01540253

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase I Study of the PI3-Kinase Inhibitor BKM120 in Combination With Docetaxel in Patients With Advanced Solid Tumors.

This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with docetaxel in treating patients with advanced solid tumor that is locally advanced, cannot be removed by surgery, or metastatic. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120 together with docetaxel may kill more tumor cells.

NCT01540253 Unspecified Adult Solid Tumor, Protocol Specific

5 Interventions

Name: PI3K inhibitor BKM120

Description: Given PO

Type: Drug

Treatment (enzyme inhibitor and chemotherapy)

Name: docetaxel

Description: Given IV

Type: Drug

Treatment (enzyme inhibitor and chemotherapy)

Name: pharmacological study

Description: Correlative studies

Type: Other

Treatment (enzyme inhibitor and chemotherapy)

Name: questionnaire administration

Description: Ancillary studies

Type: Other

Treatment (enzyme inhibitor and chemotherapy)

Name: laboratory biomarker analysis

Description: Correlative studies

Type: Other

Treatment (enzyme inhibitor and chemotherapy)


Primary Outcomes

Description: Adverse events (AE) will be coded and evaluated for severity using NCI CTCAE, version 4.0 and will be summarized by system organ class and preferred term.

Measure: Maximum tolerated dose (MTD) or recommended phase 2 dose of PI3K inhibitor BKM120

Time: 21 days

Description: AE will be coded and evaluated for severity using NCI CTCAE, version 4.0 and will be summarized by system organ class and preferred term.

Measure: Incidence AE and tolerability of PI3-kinase inhibitor BKM120 in combination with docetaxel

Time: Up to 30 days after completion of treatment

Secondary Outcomes

Description: The ORR will be calculated as the number of patients with a confirmed complete or partial response divided by the total number of patients. Tumor response will be summarized for the evaluable patient population, and the 95% confidence interval for ORR (complete response [CR] + partial response [PR]) will be presented. Response will be evaluated by revised RECIST 1.1 criteria.

Measure: Objective response rate (ORR) as assessed by the proportion of patients with a confirmed complete response (CR) or partial response (PR)

Time: Up to 6 courses

Measure: Progression-free survival (PFS)

Time: Up to 3 years

Measure: PK parameters of PI3-kinase inhibitor BKM120

Time: Baseline, days 1-7 of course 1, and then day 1 of all subsequent courses

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

dexamethasone 2 mg/day, prednisolone 10 mg/day) for at least 14 days before start of study treatment are eligible - Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (please note that co-treatment with weak inhibitors of CYP3A is allowed) - Patients who have received chemotherapy or targeted anticancer therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must recover to a grade 1 before starting the trial - Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half-lives prior to starting study drug or who have not recovered from side effects of such therapy - No concurrent intake of valproic acid, rifampin, phenobarbital, phenytoin, or carbamazepine - Patients who are currently taking therapeutic doses of warfarin sodium or any other Coumadin derivative anticoagulant - Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator Unspecified Adult Solid Tumor, Protocol Specific PRIMARY OBJECTIVES: I. To determine the dose-limiting toxicities and identify the recommended phase II dose of the combination of docetaxel and BKM 120 (P13K inhibitor BKM120) in patients with advanced solid tumors. --- P13K ---



HPO Nodes