Solid TumorsPhase 1/2NCT00600275
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
A Phase 1/2 study testing BGT226 in people with Solid Tumors and Breast Cancer, run by Novartis Pharmaceuticals at 6 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Breast Cancer, Cowden Syndrome
- What is being tested?
- BGT226
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Dec 2007to Mar 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Faber Cancer Institute
Boston, Massachusetts, 02115
Nevada Cancer Center
Las Vegas, Nevada, 89135
Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, 78229
About this study
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
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.
- Conditions
- Solid Tumors, Breast Cancer, Cowden Syndrome
- Being tested
- BGT226
- 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)
- Medical subject headings
- Breast Neoplasms, Hamartoma Syndrome, Multiple, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGT226Drug
| Study group | Role | What they receive |
|---|---|---|
| BGT226 | Experimental | Not described Receives: Drug: BGT226 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: throughout the study
Secondary outcomes (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
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600275
- Sponsor's protocol ID
- CBGT226A2101
- Status last verified
- Nov 2012
- First submitted
- 11 Jan 2008
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00600275
- Acronym / sponsor ID
- CBGT226A2101
- 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)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGT226 | Experimental | Drug: BGT226 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGT226 | Drug | BGT226 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results for CBGT226A2101 from the Novartis Clinical Trials websiteLink provided by the sponsor.
Related trials for Solid Tumors
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Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BGT226 in people with Solid Tumors and Breast Cancer, run by Novartis Pharmaceuticals at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.