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

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

Genetics Home Reference related topics:

breast cancer Cowden syndrome

MedlinePlus related topics:

Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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)

Secondary Outcome Measures:

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

Estimated Enrollment:	130
Study Start Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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	800 340 6843

Locations


United States, Massachusetts
	Dana Faber Cancer Institute	Recruiting
	Boston, Massachusetts, United States, 02115
	Contact: Kathryn Josephs 617-632-7652 kjosephs@partners.org
	Principal Investigator: Ian Krop, M.D.
	Massachusetts General Hospital	Recruiting
	Boston, Massachusetts, United States, 02114
	Contact: Natasha Isaac 617-726-6225 nisaac1@partners.org
	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: Jerry Medina 210-450-1789 gmedina@idd.org
	Principal Investigator: Francis J. Giles, M.D.

Spain
	Novartis Investigative Site - Hospital Vall d'Hebron	Recruiting
	Barcelona, Spain

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CBGT226A2101
First Received:	January 11, 2008
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00600275
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)

Study placed in the following topic categories:

Hamartoma Syndrome, Multiple

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Skin Diseases

Breast Neoplasms

Cowden's disease

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Neoplasms by Site

Syndrome

Neoplasms, Multiple Primary

Hamartoma

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00600275