Advanced Solid TumorsPhase 1NCT01421004
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
A Phase 1 study testing TKI258 in people with Advanced Solid Tumors and Excluding Breast Cancer, run by Novartis Pharmaceuticals at 14 sites in United States.
Trial summary
This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Excluding Breast Cancer
- What is being tested?
- TKI258
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2011to Jul 2014
- 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 a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists
- ECOG performance status (PS) 0, 1 or 2
- Patients must meet protocol-specified laboratory values
Who cannot join
- Patients with brain metastases
- Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- Patients who have not recovered from previous anti-cancer therapies
- Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study
- Female patients who are pregnant, breast feeding
- Fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Rush University Medical Center Rush 3
Chicago, Illinois, 60612
Sammons Cancer Center - Texas Oncology SC-2
Dallas, Texas, 78246
City of Hope National Medical Center SC-2
Duarte, California, 91010-3000
Florida Cancer Specialists Sarasota Office
Fort Myers, Florida, 33901
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, 90095
University of Wisconsin Univ Wisc
Madison, Wisconsin, 53792
Sarah Cannon Research Institute Sarah Cannon Research (SC)
Nashville, Tennessee, 37203
University of Oklahoma Health Sciences Center OUHSC - SC
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232-1305
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, 84112
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
San Antonio, Texas, 78229
University of California San Francisco UCSF (SC)
San Francisco, California, 94101
Washington University School of Medicine SC
St Louis, Missouri, 63110
Montefiore Medical Center Montefiore Medical Center (SC)
The Bronx, New York, 10467
About this study
Official title: A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors
This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
- Conditions
- Advanced Solid Tumors, Excluding Breast Cancer
- Being tested
- TKI258
- Keywords
- cancer, tumors, phase I, crossover, bioequivalence
- 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 |
|---|---|---|
| 500 mg FMI capsule + 250 mg FMI tablet | Experimental | BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet Receives: Drug: TKI258 |
| 500 mg TKI258 FMI capsule +250 mg FMI tablet | Experimental | BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule Receives: Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax
Measured: 9 days
Secondary outcomes (2)
Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer
Measured: up to 30 days after the last dose of study drug
Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer
Measured: Every 8 weeks until progression of disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2014
- Study completionJul 2014
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartitis Pharmaceuticals, Study director, Novartitis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421004
- Sponsor's protocol ID
- CTKI258A2128
- Status last verified
- Jan 2015
- First submitted
- 11 Aug 2011
- Last updated
- 21 Dec 2020
- Results posted
- 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, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01421004
- Acronym / sponsor ID
- CTKI258A2128
- Conditions
- Advanced Solid Tumors, Excluding Breast Cancer
- Keywords
- cancer, tumors, phase I, crossover, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Aug 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.
This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500 mg FMI capsule + 250 mg FMI tablet | Experimental | Drug: TKI258BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet |
| 500 mg TKI258 FMI capsule +250 mg FMI tablet | Experimental | Drug: TKI258BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule |
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 a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists
- ECOG performance status (PS) 0, 1 or 2
- Patients must meet protocol-specified laboratory values
Key exclusion criteria (7 listed)
- Patients with brain metastases
- Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- Patients who have not recovered from previous anti-cancer therapies
- Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study
- Female patients who are pregnant, breast feeding
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 | 500 mg FMI capsule + 250 mg FMI tablet, 500 mg TKI258 FMI capsule +250 mg FMI tablet |
Primary outcome
Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax
Time frame: 9 days
2 secondary outcomes
Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer
Time frame: up to 30 days after the last dose of study drug
Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer
Time frame: Every 8 weeks until progression of disease
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 CTKI258A2128 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
Novartitis Pharmaceuticals study director
Novartitis Pharmaceuticals
14 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 and Excluding Breast Cancer, run by Novartis Pharmaceuticals at 14 sites in United States.
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 7 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 14 sites in United States. 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?
Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax (time frame: 9 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.