A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
NCT ID: NCT00600275
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
57 participants
INTERVENTIONAL
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BGT226
BGT226
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BGT226
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, United States
Princess Margaret Hospital
Toronto, , Canada
Novartis Investigative Site
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CBGT226A2101 from the Novartis Clinical Trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CBGT226A2101
Identifier Type: -
Identifier Source: org_study_id