A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00600275
First received: January 11, 2008
Last updated: November 26, 2012
Last verified: November 2012
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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:
Bannayan-Riley-Ruvalcaba syndrome
breast cancer
Cowden syndrome
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 ]
| Enrollment: | 57 |
| Study Start Date: | December 2007 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BGT226 | 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
Locations
| United States, Massachusetts | |
| Dana Faber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| 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
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00600275 History of Changes |
| Other Study ID Numbers: | CBGT226A2101 |
| Study First Received: | January 11, 2008 |
| Last Updated: | November 26, 2012 |
| 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:
|
Breast Neoplasms Hamartoma Syndrome, Multiple Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Hamartoma Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 21, 2013