Advanced Solid TumorPhase 1NCT01195376
A Study of BEZ235 in Adult Japanese Patients With Advanced Solid Tumors
A Phase 1 study testing BEZ235 in people with Advanced Solid Tumor, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
In this study, BEZ235 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BEZ235
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2010to Jul 2013
- 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
- Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
- At least one measurable lesion as defined by RECIST criteria for solid tumors.
- Age ≥ 20
- Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
- Life expectancy of ≥ 12 weeks
- Patients must have the laboratory values Patients in the expansion part of this study have to meet the following criteria in addition to the criteria described above.
- Availability of a representative tumor tissue specimen (either archival tumor or fresh tumor biopsy) for pre-screening.
- Patients whose molecular status proved to meet the criteria (PIK3CA mutation/amplification and/or PTEN mutation and/or low/null PTEN expression) during pre-screening.
Who cannot join
- Patients who have brain metastases or who have signs/symptoms attributable and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Patients with unresolved diarrhea ≥ CTCAE grade 2
- Patients with a history of photosensitivity reactions to other drugs
- Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least consecutive 1 years (i.e., who has had menses any time in the preceding consecutive 2 years), must have a negative serum pregnancy test ≤ 7 days prior to starting BEZ235.
- 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
Yufu, Oita Prefecture, 879-5593
About this study
Official title: A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
In this study, BEZ235 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese patients.
- Conditions
- Advanced Solid Tumor
- Being tested
- BEZ235
- Keywords
- PI3K, mTOR, Advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEZ235Drug
| Study group | Role | What they receive |
|---|---|---|
| BEZ235 Dose Escalation once daily | Experimental | oral BEZ235 once daily (q.d.) Receives: Drug: BEZ235 |
| BEZ Dose escalation twice daily | Experimental | oral BEZ235 twice daily (b.i.d.) Receives: Drug: BEZ235 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish Maximum tolerate dose (MTD)
Measured: Every week
Secondary outcomes (4)
Safety assessed by type, frequency and severity of adverse events
Measured: Every week
Efficacy assessed by RECIST
Measured: Every 2 months
To characterize the PK profiles
Measured: Every 2 weeks
To assess the biomarkers
Measured: Every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies 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
- 35 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
- NCT01195376
- Sponsor's protocol ID
- CBEZ235A1101
- Status last verified
- Apr 2016
- First submitted
- 2 Sep 2010
- Last updated
- 9 Dec 2020
- Results posted
- No
Publications
Toyoda M, Watanabe K, Amagasaki T, Natsume K, Takeuchi H, Quadt C, Shirao K, Minami H. A phase I study of single-agent BEZ235 special delivery system sachet in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2019 Feb;83(2):289-299. doi: 10.1007/s00280-018-3725-2. Epub 2018 Nov 16.
PubMed 30446785
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01195376
- Acronym / sponsor ID
- CBEZ235A1101
- Conditions
- Advanced Solid Tumor
- Keywords
- PI3K, mTOR, Advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Sep 2010 (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.
In this study, BEZ235 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEZ235 Dose Escalation once daily | Experimental | Drug: BEZ235oral BEZ235 once daily (q.d.) |
| BEZ Dose escalation twice daily | Experimental | Drug: BEZ235oral BEZ235 twice daily (b.i.d.) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
- At least one measurable lesion as defined by RECIST criteria for solid tumors.
- Age ≥ 20
- Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
- Life expectancy of ≥ 12 weeks
Key exclusion criteria (6 listed)
- Patients who have brain metastases or who have signs/symptoms attributable and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Patients with unresolved diarrhea ≥ CTCAE grade 2
- Patients with a history of photosensitivity reactions to other drugs
- Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least consecutive 1 years (i.e., who has had menses any time in the preceding consecutive 2 years), must have a negative serum pregnancy test ≤ 7 days prior to starting BEZ235.
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 |
|---|---|---|
| BEZ235 | Drug | BEZ Dose escalation twice daily, BEZ235 Dose Escalation once daily |
Primary outcome
To establish Maximum tolerate dose (MTD)
Time frame: Every week
4 secondary outcomes
Safety assessed by type, frequency and severity of adverse events
Time frame: Every week
Efficacy assessed by RECIST
Time frame: Every 2 months
To characterize the PK profiles
Time frame: Every 2 weeks
To assess the biomarkers
Time frame: Every 2 months
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 9 Dec 2020.
- Derived from this study: PubMed 30446785Toyoda M, Watanabe K, Amagasaki T, Natsume K, Takeuchi H, Quadt C, Shirao K, Minami H. A phase I study of single-agent BEZ235 special delivery system sachet in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2019 Feb;83(2):289-299. doi: 10.1007/s00280-018-3725-2. Epub 2018 Nov 16.
- Results for CBEZ235A1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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 BEZ235 in people with Advanced 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 8 inclusion and 6 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 9 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 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 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?
To establish Maximum tolerate dose (MTD) (time frame: Every week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195376, which also lists 1 linked publication.
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 9 Dec 2020.