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Pharmacodynamic Study of BKM120 in Breast Cancer

NCT01513356 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-04-02

No results posted yet for this study

Summary

BKM120 is a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor, currently under investigation in a first-in-man study in patients with advanced solid tumors (wild type and PIK3CA-mutated). Consistent, dose-dependent pharmacodynamic activity has been demonstrated and clear signs of anti-tumor activity have been seen with BKM120.

Conditions

Interventions

DRUG

BKM120

BKM120 will be administered on a continuous once daily dosing schedule at a dose of 100 mg (p.o.)until progression of disease or unacceptable toxicity or a maximum of 4 weeks.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Sofia Perea, Director Clinical Trials Unit.

    lead OTHER

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Spain

Study Locations

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Entities

Diseases
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 NCT01513356 on ClinicalTrials.gov