Advanced Solid TumorsPhase 1NCT01928459
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
A Phase 1 study testing BGJ398 and BYL719 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Novartis Pharmaceuticals at 22 sites in 12 countries.
Trial summary
To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- BGJ398 and BYL719
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 22 sitesin 12 countries
- Study dates
- Oct 2013to Aug 2016
- 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
- Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
- Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
- Measurable disease defined by RECIST v1.1
- ECOG performance status of ≤2
Who cannot join
- Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
- Colorectal cancer (for patients enrolled to expansion part)
- Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
- Use of medications that increase serum levels of phosphorus and/or calcium
- Inorganic phosphorus outside of normal limits
- Total and ionized serum calcium outside of normal limits
Trial locations and contacts
22 sites in 12 countries.
22 sites in 12 countries
United States7 sites
University of Michigan Comprehensive Cancer Center SC
Ann Arbor, Michigan, 48109-0944
Karmanos Cancer Institute Dept of Onc
Detroit, Michigan, 48201
Vanderbilt University Medical Center Dept of Onc
Nashville, Tennessee, 37232
Memorial Sloan Kettering Cancer Center Onc Dept
New York, New York, 10065
Cancer Therapy & Research Center / UT Health Science Center SC
San Antonio, Texas, 78229
Washington University School of Medicine Onc Dept
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center & Research Institute Moffitt 4
Tampa, Florida, 33612
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28050
Novartis Investigative Site
Seville, Andalusia, 41013
France2 sites
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Saint-Herblain, 44805
Italy2 sites
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Modena, MO, 41100
Germany1 site
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors
To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.
Read the detailed description
This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Being tested
- BGJ398, BYL719
- Keywords
- BGJ398, BYL719, advanced solid tumor, metastatic breast cancer, PK3CA, FGFR, fibroblast growth factor receptor
- Medical subject headings
- Breast Neoplasms, Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGJ398Drug
BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
BYL719Drug
BYL719 will be administered orally once daily on each day of the 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic breast cancer | Experimental | Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3. Receives: Drug: BGJ398; Drug: BYL719 |
| Solid tumor arm 1 | Experimental | Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA. Receives: Drug: BGJ398; Drug: BYL719 |
| Solid tumor arm 2 | Experimental | Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3 Receives: Drug: BGJ398; Drug: BYL719 |
| Dose escalation | Experimental | To determine the MTD or RDE of the combination of BGJ398 with BYL719 in patients with advanced or metastastic solid tumors that express mutations to PIK3CA. Receives: Drug: BGJ398; Drug: BYL719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.
Measured: Approximately 8 months
Secondary outcomes (4)
Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE)
This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions and reductions
Measured: Every 28 days from baseline visit until end of study visit
Overall response rate
Assessment of preliminary antitumor activity of the combination of BGJ398 with BYL719; Overall response rate = complete response + partial response
Measured: Every two months from the date of baseline CT scan
Progression free survival
Assessment of preliminary antitumor activity of the combination of BGJ398 with BYL719
Measured: Every two months from the date of baseline CT scan
Time vs. concentration profile of BGJ398 and BYL719
Plasma concentration versus time profiles. Plasma PK parameters will be used to characterize the PK profiles of the combination of BGJ398 with BYL719
Measured: Every 28 days for up to 10 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT01928459
- Sponsor's protocol ID
- CBGJ398X2102
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2013
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01928459
- Acronym / sponsor ID
- CBGJ398X2102
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Keywords
- BGJ398, BYL719, advanced solid tumor, metastatic breast cancer, PK3CA, FGFR, fibroblast growth factor receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Aug 2013 (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.
To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.
Detailed description
This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metastatic breast cancer | Experimental | Drug: BGJ398, Drug: BYL719Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3. |
| Solid tumor arm 1 | Experimental | Drug: BGJ398, Drug: BYL719Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA. |
| Solid tumor arm 2 | Experimental | Drug: BGJ398, Drug: BYL719Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3 |
| Dose escalation | Experimental | Drug: BGJ398, Drug: BYL719To determine the MTD or RDE of the combination of BGJ398 with BYL719 in patients with advanced or metastastic solid tumors that express mutations to PIK3CA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
- Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
- Measurable disease defined by RECIST v1.1
- ECOG performance status of ≤2
Key exclusion criteria (6 listed)
- Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
- Colorectal cancer (for patients enrolled to expansion part)
- Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
- Use of medications that increase serum levels of phosphorus and/or calcium
- Inorganic phosphorus outside of normal limits
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 |
|---|---|---|
| BGJ398BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle. | Drug | Dose escalation, Metastatic breast cancer, Solid tumor arm 1, Solid tumor arm 2 |
| BYL719BYL719 will be administered orally once daily on each day of the 28-day cycle. | Drug | Dose escalation, Metastatic breast cancer, Solid tumor arm 1, Solid tumor arm 2 |
Primary outcome
Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719
Time frame: Approximately 8 months
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.
4 secondary outcomes
Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE)
Time frame: Every 28 days from baseline visit until end of study visit
Overall response rate
Time frame: Every two months from the date of baseline CT scan
Progression free survival
Time frame: Every two months from the date of baseline CT scan
Time vs. concentration profile of BGJ398 and BYL719
Time frame: Every 28 days for up to 10 cycles
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.
- Results for CBGJ398X2102 from the Novartis Clinical Trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
22 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGJ398 and BYL719 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Novartis Pharmaceuticals at 22 sites in 12 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 4 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 22 sites in United States, Spain, France, Italy, Australia and 7 more countries. 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?
Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719 (time frame: Approximately 8 months). 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 9 Dec 2020.