PI3K Inhibitor BKM120 and Docetaxel in Treating Patients With Advanced Solid Tumor That is Locally Advanced, Cannot Be Removed By Surgery, or Metastatic
|ClinicalTrials.gov Identifier: NCT01540253|
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : June 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: PI3K inhibitor BKM120 Drug: docetaxel Other: pharmacological study Other: questionnaire administration Other: laboratory biomarker analysis||Phase 1|
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.
II. To determine the safety and tolerability of this combination. III. To determine any pharmacokinetic (PK) interaction between BKM12O and docetaxel.
I. To assess any preliminary evidence of efficacy with this combination in patients with advanced cancers.
II. To evaluate phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutations as predictive biomarkers of efficacy for the combination.
III. To evaluate PIK3CA polymorphisms and polymorphisms in BKM120 transport and metabolism as predictors of toxicity and/or efficacy.
OUTLINE: This is a dose-escalation study of PI3K inhibitor BKM120.
Patients receive PI3K inhibitor BKM120 orally (PO) once daily (QD) and docetaxel intravenously (IV) over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the PI3-Kinase Inhibitor BKM120 in Combination With Docetaxel in Patients With Advanced Solid Tumors.|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2016|
Experimental: Treatment (enzyme inhibitor and chemotherapy)
Patients receive PI3K inhibitor BKM120 PO QD and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: PI3K inhibitor BKM120
Other Names:Drug: docetaxel
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: questionnaire administration
Ancillary studiesOther: laboratory biomarker analysis
- Maximum tolerated dose (MTD) or recommended phase 2 dose of PI3K inhibitor BKM120 [ Time Frame: 21 days ]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.
- Incidence AE and tolerability of PI3-kinase inhibitor BKM120 in combination with docetaxel [ Time Frame: Up to 30 days after completion of treatment ]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.
- Objective response rate (ORR) as assessed by the proportion of patients with a confirmed complete response (CR) or partial response (PR) [ Time Frame: Up to 6 courses ]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.
- Progression-free survival (PFS) [ Time Frame: Up to 3 years ]
- PK parameters of PI3-kinase inhibitor BKM120 [ Time Frame: Baseline, days 1-7 of course 1, and then day 1 of all subsequent courses ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540253
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Alex Adjei||Roswell Park Cancer Institute|