Clinical trial NCT00600275: A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Breast Cancer
Cowden Syndrome
Keywords: 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)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-01-24
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: throughout the study
Secondary outcomes:
measure: Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging
timeFrame: throughout the study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Faber Cancer Institute
state: Massachusetts
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center (CTRC)
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret Hospital
city: Barcelona
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: