Advanced Solid TumorPhase 1NCT01546428
A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
A Phase 1 study testing INC280 in people with Advanced Solid Tumor, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280 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?
- INC280
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesJapan
- Study dates
- Feb 2012to Jan 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
- Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Good organ (hepatic, kidney, BM) function at screening/baseline visit.
Who cannot join
- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.
- Undergone a bone marrow or solid organ transplant.
- Women who are pregnant or breast feeding.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Fukuoka, 811-1395
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
About this study
INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280
- Conditions
- Advanced Solid Tumor
- Being tested
- INC280
- Keywords
- c-MET, Advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INC280Drug
| Study group | Role | What they receive |
|---|---|---|
| INC280 | Experimental | Not described Receives: Drug: INC280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part
Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.
Measured: 4 weeks
Secondary outcomes (3)
Incidence and severity of adverse events and serious adverse events, changes in laboratory values
Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
Measured: 4 months
Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2
Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.
Measured: 1 month
Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM
Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM
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 posted7 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionJan 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT01546428
- Sponsor's protocol ID
- CINC280X1101
- Status last verified
- Jun 2016
- First submitted
- 27 Feb 2012
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01546428
- Acronym / sponsor ID
- CINC280X1101
- Conditions
- Advanced Solid Tumor
- Keywords
- c-MET, Advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Mar 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.
INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INC280 | Experimental | Drug: INC280 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Good organ (hepatic, kidney, BM) function at screening/baseline visit.
Key exclusion criteria (5 listed)
- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.
- Undergone a bone marrow or solid organ transplant.
- Women who are pregnant or breast feeding.
- 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 |
|---|---|---|
| INC280 | Drug | INC280 |
Primary outcome
Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part
Time frame: 4 weeks
Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.
3 secondary outcomes
Incidence and severity of adverse events and serious adverse events, changes in laboratory values
Time frame: 4 months
Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2
Time frame: 1 month
Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM
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 19 Dec 2020.
- Results for CINC280X1101 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 INC280 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 3 inclusion and 5 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 19 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?
Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part (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 19 Dec 2020.