NCT00600275

Brief Summary

This is a phase I/II clinical research study with BGT226, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part followed by a safety expansion part and a Phase II expansion part. Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial will be opened for enrollment. Phase I safety expansion part will enroll advanced solid tumors. Phase II expansion part will enroll advanced breast cancer. An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
3 countries

6 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

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

December 17, 2020

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

January 11, 2008

Last Update Submit

December 11, 2020

Conditions

Solid TumorsBreast CancerCowden Syndrome

Keywords

BGT226Solid tumorsBreast cancerCowden SyndromePhosphatidylinositol 3'-kinase (PI3K) inhibitorAdvanced solid tumors (including sporadic and Cowden Syndrome) (Phase I part)Advanced breast cancer (including sporadic and Cowden Syndrome) (Phase II part)

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of BGT226 (Phase I dose escalation) Safety and tolerability of BGT226 (all patients) Clinical tumor response in patients with advanced breast cancer (Phase II)

    throughout the study

Secondary Outcomes (1)

  • Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging

    throughout the study

Study Arms (1)

BGT226

EXPERIMENTAL
Drug: BGT226

Interventions

BGT226DRUG
BGT226

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
  • Phase II expansion part (advanced breast cancer)
  • Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status
  • Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease
  • At least one but not more than two prior chemotherapy regimens for the unresectable tumor
  • Measurable disease by MRI or CT scan
  • Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome
  • Age ≥ 18
  • World Health Organization (WHO) Performance Status of ≤ 2

You may not qualify if:

  • Hematopoietic:
  • No diabetes mellitus or history of gestational diabetes mellitus
  • No acute or chronic renal disease
  • No acute or chronic liver disease
  • No acute or chronic pancreatitis
  • 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 (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Faber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Nevada Cancer Center

Las Vegas, Nevada, 89135, United States

Location

Cancer Therapy and Research Center (CTRC)

San Antonio, Texas, 78229, United States

Location

Princess Margaret Hospital

Toronto, Canada

Location

Novartis Investigative Site

Barcelona, Spain

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsHamartoma Syndrome, MultipleHereditary Sensory and Autonomic Neuropathies

Interventions

8-(6-methoxypyridin-3-yl)-3-methyl-1-(4-piperazin-1-yl-3-trifluoromethylphenyl)-1,3-dihydroimidazo(4,5-c)quinolin-2-one

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHamartomaNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital Abnormalities

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

January 11, 2008

First Posted

January 24, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2010

Last Updated

December 17, 2020

Record last verified: 2012-11

Locations

US(4)CA(1)ES(1)