Gastrointestinal Stromal TumorPhase 2NCT01110668
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
A Phase 2 study testing Nilotinib in people with Gastrointestinal Stromal Tumor, run by Novartis Pharmaceuticals at 4 sites in Turkey (Türkiye).
Trial summary
This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor
- What is being tested?
- Nilotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Sep 2008to Sep 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
- Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose
- At least one measurable site of disease on CT scan at Visit-2
- WHO Performance Status of 0, 1 or 2 at Visit-2
- Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2
Who cannot join
- Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.
- Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks
- Prior or concomitant malignancies other than GIST
- Impaired cardiac function at Visit-1 or 2
- Patients with severe and/or uncontrolled concurrent medical disease
- Use of therapeutic coumarin derivatives
Show all 11Show fewer
- Use of any medications that prolong the QT interval
- Use of CYP3A4 inhibitors
- Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery
- Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Novartis Investigative Site
Adana
Novartis Investigative Site
Ankara
Novartis Investigative Site
Istanbul
Novartis Investigative Site
Izmir
About this study
Official title: Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib
This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- Nilotinib
- Keywords
- Unresectable, metastatic gastrointestinal stromal tumor, disease progression, progression-free survival
- Medical subject headings
- Gastrointestinal Stromal Tumors, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Nilotinib | Experimental | Not described Receives: Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
Measured: every 8 weeks
Secondary outcomes (1)
To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT01110668
- Sponsor's protocol ID
- CAMN107DTR01T
- Status last verified
- Feb 2017
- First submitted
- 22 Apr 2010
- Last updated
- 28 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib
- ClinicalTrials.gov ID
- NCT01110668
- Acronym / sponsor ID
- CAMN107DTR01T
- Conditions
- Gastrointestinal Stromal Tumor
- Keywords
- Unresectable, metastatic gastrointestinal stromal tumor, disease progression, progression-free survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Apr 2010 (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 assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nilotinib | Experimental | Drug: Nilotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
- Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose
- At least one measurable site of disease on CT scan at Visit-2
- WHO Performance Status of 0, 1 or 2 at Visit-2
- Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2
Key exclusion criteria (11 listed)
- Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.
- Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks
- Prior or concomitant malignancies other than GIST
- Impaired cardiac function at Visit-1 or 2
- Patients with severe and/or uncontrolled concurrent medical 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 |
|---|---|---|
| Nilotinib | Drug | Nilotinib |
Primary outcome
To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
Time frame: every 8 weeks
1 secondary outcome
To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.
Time frame: 6 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 28 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
4 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 Nilotinib in people with Gastrointestinal Stromal Tumor, run by Novartis Pharmaceuticals at 4 sites in Turkey (Türkiye).
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 5 inclusion and 11 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 28 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 4 sites in Turkey (Türkiye). 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?
To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg. (time frame: every 8 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 28 Feb 2017.