NCT01068483

Brief Summary

This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part. Once the MTD has been defined, the MTD expansion part will be opened for enrollment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Nov 2008

Typical duration for phase_1 breast-cancer

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 8, 2020

Status Verified

April 1, 2013

Enrollment Period

2.8 years

First QC Date

February 11, 2010

Last Update Submit

December 6, 2020

Conditions

Breast CancerColon CancerOvarian CancerEndometrium Cancer

Keywords

Advanced solid tumorsBreast CancerColon CancerOvarian CancerEndometrium cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of BKM120

    throughout the study

Secondary Outcomes (5)

  • Safety and tolerability of BKM120

    throughout the study

  • Pharmacokinetics of BKM120

    throughout the study

  • Changes in tumor metabolic activity

    throughout the study

  • Pharmacodynamics of BKM120

    throughout the study

  • Clinical tumor response in patients with tumors that show PI3K pathway activation

    throughout the study

Study Arms (1)

BKM120

EXPERIMENTAL

Dose escalation followed by dose expansion

Drug: BKM120

Interventions

BKM120DRUG
BKM120

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients:
  • Histologically-confirmed advanced solid tumors
  • Progressive, recurrent unresectable disease
  • World Health Organization (WHO) Performance status ≤ 2
  • No history of primary brain tumor or brain metastases
  • MTD Expansion part:
  • Histologically-confirmed advanced solid tumors
  • Progressive, recurrent unresectable disease
  • World Health Organization (WHO) Performance status ≤ 2
  • No history of primary brain tumor; no brain metastases unless asymptomatic and clinically stable for ≥ 3 months
  • Patients with genetic or molecular alteration of the PI3K pathway

You may not qualify if:

  • Prior treatment with a PI3K inhibitor
  • History of or active major depressive episode, bipolar disorder, schizophrenia, or history of suicidal attempt or ideation
  • No clinically manifest diabetes mellitus (treated and/or with clinical signs)
  • No acute or chronic renal disease
  • No acute or chronic liver disease
  • No acute or chronic pancreatitis
  • No unresolved diarrhea
  • No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
  • No acute myocardial infarction or unstable angina pectoris within the past 3 months
  • Not pregnant or nursing and fertile patients must use barrier contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3075 EA, Netherlands

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColonic NeoplasmsOvarian NeoplasmsEndometrial Neoplasms

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 15, 2010

Study Start

November 1, 2008

Primary Completion

September 1, 2011

Study Completion

August 1, 2012

Last Updated

December 8, 2020

Record last verified: 2013-04

Locations

ES(1)CA(1)US(1)NL(2)