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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600275
• Other study ID #: CBGT226A2101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2007

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cowden Syndrome
• Hamartoma Syndrome, Multiple
• Solid Tumors
• Syndrome

Intervention

Drug:
• BGT226

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto
Spain	Novartis Investigative Site	Barcelona
United States	Dana Faber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Nevada Cancer Center	Las Vegas	Nevada
United States	Cancer Therapy and Research Center (CTRC)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Results for CBGT226A2101 from the Novartis Clinical Trials website