Tumor With Alterations of the FGF-RPhase 1NCT01697605
A Phase I Study of Oral BGJ398 in Asian Patients
A Phase 1 study testing BGJ398 in people with Tumor With Alterations of the FGF-R, run by Novartis Pharmaceuticals at 8 sites in 2 countries.
Trial summary
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor With Alterations of the FGF-R
- What is being tested?
- BGJ398
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 19 Oct 2012to 7 Feb 2019
- 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 advanced solid tumors with FGF-R alteration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ function
Who cannot join
- Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Japan5 sites
National Cancer Center Hospital East (NCEE)
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Novartis Investigative Site
Sayama, Osaka, 589 8511
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
China3 sites
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Guangzhou, Guangdong, 51000
Novartis Investigative Site
Guangzhou, 510060
About this study
Official title: A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
Read the detailed description
This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.
- Conditions
- Tumor With Alterations of the FGF-R
- Being tested
- BGJ398
- Keywords
- Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGJ398Drug
| Study group | Role | What they receive |
|---|---|---|
| BGJ398 | Experimental | Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease. Receives: Drug: BGJ398 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate and category of dose limiting toxicities (DLTs)
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
Measured: First cycle of 28 days
Secondary outcomes (12)
Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
To characterize the safety and tolerability of oral BGJ398
Measured: From within 21 days of first treatment to 28 days after treatment discontinuation
Changes in hematology and chemistry values
hematology and chemistry values
Measured: From baseline to 28 days after treatment discontinuation
Assessments of physical examinations, vital signs and electrocardiograms (ECGs)
Measured: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Time vs. concentration profiles
To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites
Measured: 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
Preliminary anti-tumor activity
Assessed based on RECIST version 1.1
Measured: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Best overall response (BOR)
Assessed by investigator per RECIST version 1.1. BOR is the best response recorded until disease progression.
Measured: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Overall response rate (ORR)
Assessed by investigator per RECIST version 1.1. ORR is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).
Measured: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Progression-free survival (PFS)
PFS is defined as the times from the date of first dose of BGJ398 to the date of the first documented disease progression, date of death due to any cause or until a new anticancer therapy is initiated, whichever occurs first.
Measured: From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
Duration of all Adverse Events (AEs)
To characterize the safety and tolerability of oral BGJ398
Measured: From within 21 days of first treatment to 28 days after treatment discontinuation
Duration of Serious Advers Events (SAEs)
To characterize the safety and tolerability of oral BGJ398
Measured: From within 21 days of first treatment to 28 days after treatment discontinuation
Severity of all Adverse Events (AEs)
To characterize the safety and tolerability of oral BGJ398
Measured: From within 21 days of first treatment to 28 days after treatment discontinuation
Severity of all Serious Advers Events (SAEs)
To characterize the safety and tolerability of oral BGJ398
Measured: From within 21 days of first treatment to 28 days after treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start19 Oct 2012
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor With Alterations of the FGF-RStudies 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
- 9 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
- NCT01697605
- Sponsor's protocol ID
- CBGJ398X1101
- Status last verified
- Mar 2020
- First submitted
- 19 Sep 2012
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
- ClinicalTrials.gov ID
- NCT01697605
- Acronym / sponsor ID
- CBGJ398X1101
- Conditions
- Tumor With Alterations of the FGF-R
- Keywords
- Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2012 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 2 Oct 2012 (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 evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
Detailed description
This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGJ398 | Experimental | Drug: BGJ398Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease. |
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 advanced solid tumors with FGF-R alteration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ function
Key exclusion criteria (3 listed)
- Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| BGJ398 | Drug | BGJ398 |
Primary outcome
Incidence rate and category of dose limiting toxicities (DLTs)
Time frame: First cycle of 28 days
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
12 secondary outcomes
Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Changes in hematology and chemistry values
Time frame: From baseline to 28 days after treatment discontinuation
Assessments of physical examinations, vital signs and electrocardiograms (ECGs)
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Time vs. concentration profiles
Time frame: 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
Preliminary anti-tumor activity
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Best overall response (BOR)
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Overall response rate (ORR)
Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
Progression-free survival (PFS)
Time frame: From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
Duration of all Adverse Events (AEs)
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Duration of Serious Advers Events (SAEs)
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Severity of all Adverse Events (AEs)
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
Severity of all Serious Advers Events (SAEs)
Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
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 CBGJ398X1101 can be found on the Novartis Clinical Trials Results websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGJ398 in people with Tumor With Alterations of the FGF-R, run by Novartis Pharmaceuticals at 8 sites in 2 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 3 inclusion and 3 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 8 sites in Japan, China. 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 and category of dose limiting toxicities (DLTs) (time frame: First cycle of 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 8 Dec 2020.