CancerPhase 1NCT00742105
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan
A Phase 1 study testing BGT226 in people with Cancer and Solid Tumor, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Advanced Solid Tumor
- What is being tested?
- BGT226
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesJapan
- Study dates
- 17 Nov 2008to 22 Dec 2009
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- World Health Organization (WHO) Performance Status of ≤ 2
- Histologically-confirmed, advanced solid tumors
- Progressive, recurrent unresectable disease
- Age ≥ 20
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
Show all 9Show fewer
- 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
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681
About this study
Official title: A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan
This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.
- Conditions
- Cancer, Solid Tumor, Advanced Solid Tumor
- Being tested
- BGT226
- Keywords
- PI3K, mTOR, Advanced solid tumor, Adult
- Medical subject headings
- Neoplasms
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.
Incidence of dose limiting toxicity (DLT) at each dose level
Measured: 22-28 days
Secondary outcomes (4)
Safety measured by type, frequency and severity of adverse drug reactions
Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)
Measured: Every 4 weeks
Preliminary Efficacy od BGT226
Measured by Response Evaluation criteria in Solid Tumors (RECIST)
Measured: Every 8 weeks
Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling
Measured: Baseline, every 3 weeks
Biomarkers: Percentage of change, pre- versus post-treatment
Measured: Every month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study start17 Nov 2008
- Primary completion22 Dec 2009
- Study completion22 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00742105
- Sponsor's protocol ID
- CBGT226A1101
- Status last verified
- Sep 2018
- First submitted
- 25 Aug 2008
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan
- ClinicalTrials.gov ID
- NCT00742105
- Acronym / sponsor ID
- CBGT226A1101
- Conditions
- Cancer, Solid Tumor, Advanced Solid Tumor
- Keywords
- PI3K, mTOR, Advanced solid tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2008 (actual)
- Primary completion
- 22 Dec 2009 (actual)
- Study completion
- 22 Dec 2009 (actual)
- First posted
- 27 Aug 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 study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGT226 | Experimental | Drug: BGT226 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- World Health Organization (WHO) Performance Status of ≤ 2
- Histologically-confirmed, advanced solid tumors
- Progressive, recurrent unresectable disease
- Age ≥ 20
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
Incidence of dose limiting toxicity (DLT) at each dose level
Time frame: 22-28 days
4 secondary outcomes
Safety measured by type, frequency and severity of adverse drug reactions
Time frame: Every 4 weeks
Preliminary Efficacy od BGT226
Time frame: Every 8 weeks
Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling
Time frame: Baseline, every 3 weeks
Biomarkers: Percentage of change, pre- versus post-treatment
Time frame: Every month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGT226 in people with Cancer and Solid Tumor, run by Novartis Pharmaceuticals at 2 sites in Japan.
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 4 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: stopped early, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 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.
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 was stopped early. Results are not available in the source record.
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?
Incidence of dose limiting toxicity (DLT) at each dose level (time frame: 22-28 days). 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 25 Sep 2018.