A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00600275

Purpose

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.

Condition	Intervention	Phase
Solid Tumors Breast Cancer Cowden Syndrome	Drug: BGT226	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I/II, Multi-center, Open-label Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer Cowden syndrome Help Me Understand Genetics

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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) [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	December 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BGT226: Experimental	Drug: BGT226

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

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

Exclusion criteria

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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600275

Contacts

Contact: Novartis Pharmaceuticals

800 340 6843

Locations

United States, Massachusetts
Dana Faber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact 617-632-7652
Principal Investigator: Ian Krop, M.D.
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact 617-726-6225
Principal Investigator: Steven Isakoff, M.D.
United States, Nevada
Nevada Cancer Center	Recruiting
Las Vegas, Nevada, United States, 89135
Principal Investigator: Sunil Sharma, M.D.
United States, Texas
Cancer Therapy and Research Center (CTRC)	Recruiting
San Antonio, Texas, United States, 78229
Contact 210-450-1789
Principal Investigator: Francis J. Giles, M.D.
Canada
Princess Margaret Hospital	Recruiting
Toronto, Canada
Principal Investigator: Lillian Siu, M.D.
Spain
Novartis Investigative Site	Recruiting
Barcelona, Spain

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CBGT226A2101
Study First Received:	January 11, 2008
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00600275 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

BGT226
Solid tumors
Breast cancer
Cowden Syndrome

Phosphatidylinositol 3'-kinase (PI3K) inhibitor
Advanced solid tumors (including sporadic and Cowden Syndrome) (Phase I part)
Advanced breast cancer (including sporadic and Cowden Syndrome) (Phase II part)

Additional relevant MeSH terms:

Neoplasms
Hamartoma Syndrome, Multiple
Neoplastic Syndromes, Hereditary
Neoplasms by Site
Genetic Diseases, Inborn

Skin Diseases
Neoplasms, Multiple Primary
Breast Neoplasms
Hamartoma
Breast Diseases

ClinicalTrials.gov processed this record on March 18, 2010