Adenocarcinoma, ScirrhousPhase 2NCT01576380
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients
A Phase 2 study testing TKI258 in people with Adenocarcinoma, Scirrhous and Linitis Plastica, run by Novartis Pharmaceuticals at 8 sites in Japan.
Trial summary
This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adenocarcinoma, Scirrhous, Linitis Plastica, Stomach Neoplasms
- 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
- 11 participants
- Where
- 8 sitesJapan
- Study dates
- Jun 2012to Sep 2013
- Phase
- Phase 2
- 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
- Diagnosis of advanced/metastatic scirrhous gastric carcinoma
- Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion
- Patients previously treated with one or two systemic lines
- Documented radiological confirmation of disease progression
- ECOG performance status of 0 to 2
- Male and female patients aged 20 years or greater
- Adequate liver, renal, and hematologic function
Who cannot join
- Patients who received prior treatment with an FGFR inhibitor
- Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- Patients with another primary malignancy within 3 years prior to starting study treatment
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Koto, Tokyo, 135-8550
Novartis Investigative Site
Matsuyama, Ehime, 791-0280
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
Novartis Investigative Site
Sunto-gun, Shizuoka, 411-8777
Novartis Investigative Site
Takatsuki, Osaka, 569-8686
About this study
Official title: A Single-arm, Multi-center, Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Adult Patients With Advanced Scirrhous Gastric Carcinoma That Have Progressed After One or Two Prior Systemic Treatments
This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.
- Conditions
- Adenocarcinoma, Scirrhous, Linitis Plastica, Stomach Neoplasms, Stomach Diseases, Neoplasms by Site, Neoplasms
- Being tested
- TKI258
- Keywords
- Solid tumors, Advanced scirrhous gastric carcinoma, Gastric Cancer, Second-line or third-line treatment, VEGF, FGFR, Neoplasms, Gastric Neoplasms, Cancer, Carcinoma, Gastric Diseases, Female Genital Diseases, Tumors, Oral Administration, Capsules, TKI258, TKI-258, TKI 258
- Medical subject headings
- Adenocarcinoma, Scirrhous, Linitis Plastica, Stomach Neoplasms, Stomach Diseases, Neoplasms by Site, Neoplasms, Carcinoma, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKI258Drug
Also called Dovitinib
TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week.
| Study group | Role | What they receive |
|---|---|---|
| TKI258 | Experimental | TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week. Receives: Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate (DCR)
Eight-week DCR is defined as the proportion of patients with best overall response of CR, PR or SD at the end of Week 8 as per local investigator's assessment.
Measured: up to 8 weeks after the start date of study treatment
Secondary outcomes (10)
time to progression (TTP)
TTP is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to underlying cancer as per local investigator's assessment.
Measured: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
overall response rate (ORR)
ORR is defined as the proportion of patients with best overall response of CR or PR as per local investigator's assessment.
Measured: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
progression free survival (PFS)
PFS is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to any cause as per local investigator's assessment.
Measured: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
overall survival (OS)
OS is defined as the time from the start date of study treatment to the date of death from any cause.
Measured: every 8 weeks until death
disease control rate (DCR) per independent central review
Eight-week DCR is as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
Measured: up to 8 weeks after the start date of study treatment
time to progression (TTP) per independent central review
TTP as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
Measured: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Safety and tolerability of TKI258
Safety will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.
Measured: more than 30 days after the last date of study treatment
Plasma concentrations of TKI258
Pharmacokinetics (PK) of TKI258 at each scheduled time point of single dose and steady dose.
Measured: Week 1 Day 1 - Day 2: pre-dose (0 hour), 1, 2, 4, 6, 8, and 24 hour (pre-dose). and Week 4 Day 5 - Week 5 Day 1: pre-dose (0 hour), 1, 2, 4, 6, 8, 24, 48, and 72 hour (pre-dose)
overall response rate (ORR) per independent central review
ORR as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
Measured: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
progression free survival (PFS) per independent central review
PFS as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.
Measured: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma, ScirrhousStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT01576380
- Sponsor's protocol ID
- CTKI258A1201
- Status last verified
- Feb 2017
- First submitted
- 2 Apr 2012
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multi-center, Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Adult Patients With Advanced Scirrhous Gastric Carcinoma That Have Progressed After One or Two Prior Systemic Treatments
- ClinicalTrials.gov ID
- NCT01576380
- Acronym / sponsor ID
- CTKI258A1201
- Conditions
- Adenocarcinoma, Scirrhous, Linitis Plastica, Stomach Neoplasms, Stomach Diseases, Neoplasms by Site, Neoplasms
- Keywords
- Solid tumors, Advanced scirrhous gastric carcinoma, Gastric Cancer, Second-line or third-line treatment, VEGF, FGFR, Neoplasms, Gastric Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Apr 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 is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.
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: TKI258TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of advanced/metastatic scirrhous gastric carcinoma
- Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion
- Patients previously treated with one or two systemic lines
- Documented radiological confirmation of disease progression
- ECOG performance status of 0 to 2
Key exclusion criteria (4 listed)
- Patients who received prior treatment with an FGFR inhibitor
- Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- Patients with another primary malignancy within 3 years prior to starting study treatment
- 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 |
|---|---|---|
| TKI258Also: DovitinibTKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week. | Drug | TKI258 |
Primary outcome
disease control rate (DCR)
Time frame: up to 8 weeks after the start date of study treatment
Eight-week DCR is defined as the proportion of patients with best overall response of CR, PR or SD at the end of Week 8 as per local investigator's assessment.
10 secondary outcomes
time to progression (TTP)
Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression
overall response rate (ORR)
Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
progression free survival (PFS)
Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
overall survival (OS)
Time frame: every 8 weeks until death
disease control rate (DCR) per independent central review
Time frame: up to 8 weeks after the start date of study treatment
time to progression (TTP) per independent central review
Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
Safety and tolerability of TKI258
Time frame: more than 30 days after the last date of study treatment
Plasma concentrations of TKI258
Time frame: Week 1 Day 1 - Day 2: pre-dose (0 hour), 1, 2, 4, 6, 8, and 24 hour (pre-dose). and Week 4 Day 5 - Week 5 Day 1: pre-dose (0 hour), 1, 2, 4, 6, 8, 24, 48, and 72 hour (pre-dose)
overall response rate (ORR) per independent central review
Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
progression free survival (PFS) per independent central review
Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress
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 27 Feb 2017.
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TKI258 in people with Adenocarcinoma, Scirrhous and Linitis Plastica, run by Novartis Pharmaceuticals at 8 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 4 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 27 Feb 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
disease control rate (DCR) (time frame: up to 8 weeks after the start date of study treatment). 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 27 Feb 2017.