Advanced Solid TumorPhase 1NCT01387321
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies
A Phase 1 study testing BYL719 in people with Advanced Solid Tumor, run by Novartis Pharmaceuticals at 4 sites in Japan.
Trial summary
In this study, BYL719 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 investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BYL719
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesJapan
- Study dates
- 22 Sep 2011to 25 Nov 2015
- 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 18 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 Availability of a representative formalin fixed paraffin embedded tumor tissue sample
- At least one measurable or non-measurable lesion Age ≥ 18 years
- Eastern Cooperative Oncology Group(ECOG) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit
Who cannot join
- Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
- Prior treatment with PI3K inhibitor
- Patient with peripheral neuropathy NCI-CTC Grade ≥ 2
- Patient with diarrhea NCI-CTC Grade ≥ 2
- Patient with acute or chronic pancreatitis
- Impaired cardiac function or clinically significant cardiac disease incl unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug
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- Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus
- Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Koto-ku, Tokyo, 135 8550
Novartis Investigative Site
Nagoya, Aichi-ken, 460-0001
Novartis Investigative Site
Nagoya, Aichi-ken, 466 8560
About this study
In this study, BYL719 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 investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.
- Conditions
- Advanced Solid Tumor
- Being tested
- BYL719
- Keywords
- Pi3K, Advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYL719Drug
| Study group | Role | What they receive |
|---|---|---|
| BYL719 | Experimental | Not described Receives: Drug: BYL719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: 4 Weeks
Secondary outcomes (4)
Safety assessed by type, frequency and severity of adverse events
Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.
Measured: 4 Months
Efficacy assessed by RECIST
Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.
RECIST - Response Evaluation Criteria In Solid Tumors
Measured: 4 months
To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2)
Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.
Measured: 4 months
Levels of biomarkers in tumor and skin
Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study start22 Sep 2011
- Primary completion25 Nov 2015
- Study completion25 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 33 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
- NCT01387321
- Sponsor's protocol ID
- CBYL719X1101
- Status last verified
- Aug 2018
- First submitted
- 27 Jun 2011
- Last updated
- 8 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of BYL719 in Adult Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01387321
- Acronym / sponsor ID
- CBYL719X1101
- Conditions
- Advanced Solid Tumor
- Keywords
- Pi3K, Advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2011 (actual)
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 25 Nov 2015 (actual)
- First posted
- 4 Jul 2011 (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, BYL719 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 investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BYL719 | Experimental | Drug: BYL719 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologically-confirmed, advanced unresectable solid tumors Availability of a representative formalin fixed paraffin embedded tumor tissue sample
- At least one measurable or non-measurable lesion Age ≥ 18 years
- Eastern Cooperative Oncology Group(ECOG) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit
Key exclusion criteria (9 listed)
- Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
- Prior treatment with PI3K inhibitor
- Patient with peripheral neuropathy NCI-CTC Grade ≥ 2
- Patient with diarrhea NCI-CTC Grade ≥ 2
- Patient with 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 |
|---|---|---|
| BYL719 | Drug | BYL719 |
Primary outcome
Maximum Tolerated Dose
Time frame: 4 Weeks
4 secondary outcomes
Safety assessed by type, frequency and severity of adverse events
Time frame: 4 Months
Efficacy assessed by RECIST
Time frame: 4 months
To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2)
Time frame: 4 months
Levels of biomarkers in tumor and skin
Time frame: 4 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 8 Dec 2020.
- Results for CBYL719X1101 can be found on the Novartis Clinical Trials 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
4 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 BYL719 in people with Advanced Solid Tumor, run by Novartis Pharmaceuticals at 4 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 3 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 8 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 4 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?
Maximum Tolerated Dose (time frame: 4 Weeks). 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 8 Dec 2020.