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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00600275
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.


Condition or disease Intervention/treatment Phase
Solid Tumors Breast Cancer Cowden Syndrome Drug: BGT226 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: BGT226 Drug: BGT226


Outcome Measures
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Primary Outcome Measures :
  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) [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  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 [ Time Frame: throughout the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600275


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89135
United States, Texas
Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, United States, 78229
Canada
Princess Margaret Hospital
Toronto, Canada
Spain
Novartis Investigative Site
Barcelona, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00600275    
Other Study ID Numbers: CBGT226A2101
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: November 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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:
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Breast Neoplasms
Hamartoma Syndrome, Multiple
Syndrome
Disease
Pathologic Processes
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Hamartoma
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn