Advanced Solid TumorsPhase 1NCT01471548
Phase I Dose Escalating Study of TKI258
A Phase 1 study testing TKI258 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TKI258
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2008to May 2012
- 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
- Written informed consent must be obtained prior to any screening procedures
- Advanced solid tumors
- Agreement to remaining hospitalized
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control
- Demonstrate the specific hematological /blood chemistry laboratory values
Who cannot join
- Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
- Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
- Patients with CNS and/or leptomeningeal disease metastases
- Presence or history of thromboembolic or cerebrovascular events
- Impaired cardiac function or clinically significant cardiac disease
- Malabsorption syndrome or uncontrolled gastrointestinal toxicities
Show all 17Show fewer
- Patients known to be HIV- or HBV- or HCV- positive
- Patients with acute or chronic uncontrolled infection
- Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug
- Patients who have been receiving anticoagulant therapy
- Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug
- Patients who have been administering concomitant medication which may prolong the QTc interval
- Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
- Patients with a large volume of ascitic and/or pleural fluid which requires drainage
- Patients with any bone fractures
- Deemed otherwise unsuitable by the investigator
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Hidaka, Saitama, 350-1241
Novartis Investigative Site
Takatsuki, Osaka, 569-8686
About this study
Official title: A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors
The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.
- Conditions
- Advanced Solid Tumors
- Being tested
- TKI258
- Keywords
- tumor, cancer, phase1, TKI258
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKI258Drug
Also called Dovitinib
| Study group | Role | What they receive |
|---|---|---|
| TKI258 | Experimental | dose escalation Receives: Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of TKI258
Measured: 30 days
Secondary outcomes (1)
Antineoplastic activity based on the RECIST criteria
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionMay 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT01471548
- Sponsor's protocol ID
- CTKI258A1101
- Status last verified
- Apr 2016
- First submitted
- 10 Nov 2011
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01471548
- Acronym / sponsor ID
- CTKI258A1101
- Conditions
- Advanced Solid Tumors
- Keywords
- tumor, cancer, phase1, TKI258
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Nov 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.
The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKI258 | Experimental | Drug: TKI258dose escalation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent must be obtained prior to any screening procedures
- Advanced solid tumors
- Agreement to remaining hospitalized
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
Key exclusion criteria (17 listed)
- Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
- Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
- Patients with CNS and/or leptomeningeal disease metastases
- Presence or history of thromboembolic or cerebrovascular events
- Impaired cardiac function or clinically significant cardiac disease
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 |
|---|---|---|
| TKI258Also: Dovitinib | Drug | TKI258 |
Primary outcome
Maximum tolerated dose (MTD) of TKI258
Time frame: 30 days
1 secondary outcome
Antineoplastic activity based on the RECIST criteria
Time frame: 22 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 21 Dec 2020.
- Results for CTKI258A1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Advanced Solid Tumors
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Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
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A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors
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Not yet recruitingPhase 1
A Study of BON-C1393 in Adults With Advanced Solid Tumors
Solid Tumors, Advanced Solid Tumors
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 TKI258 in people with Advanced Solid Tumors, 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 7 inclusion and 17 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 21 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?
Maximum tolerated dose (MTD) of TKI258 (time frame: 30 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 21 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.