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PI3K Inhibitor BKM120 and Docetaxel in Treating Patients With Advanced Solid Tumor That is Locally Advanced, Cannot Be Removed By Surgery, or Metastatic

NCT01540253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

PI3K inhibitor BKM120

Given PO

DRUG

docetaxel

Given IV

OTHER

pharmacological study

Correlative studies

OTHER

questionnaire administration

Ancillary studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Alex Adjei · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540253 on ClinicalTrials.gov