Gastrointestinal Stromal TumorsPhase 3NCT01289028
Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
A Phase 3 study testing Nilotinib in people with Gastrointestinal Stromal Tumors, run by Novartis Pharmaceuticals at 19 sites in 2 countries.
Trial summary
This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Nilotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Nov 2008to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and therefore not amenable to surgery or combined modality with curative intent.
- Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)
- At least one measurable site of disease on CT/MRI as defined by RECIST criteria.
Who cannot join
- Prior treatment with nilotinib.
- Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1.
- Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
- Impaired cardiac function at visit 1
- Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Germany12 sites
Novartis Investigative Site
Bad Saarow, 155226
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Düsseldorf, 40479
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Frankfurt, 60488
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Halle, 06120
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Mannheim, 68167
Novartis Investigative Site
München, 81377
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Ulm, 89081
Italy7 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Padova, PD, 35100
Novartis Investigative Site
Taormina, ME, 98039
Novartis Investigative Site
Torino, TO, 10153
About this study
Official title: An Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Nilotinib
- Keywords
- GIST, Imatinib, Sunitinib, Gastrointestinal, Stromal, Tumors
- Medical subject headings
- Gastrointestinal Stromal Tumors, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
Also called AMN107
| Study group | Role | What they receive |
|---|---|---|
| Nilotinib | Experimental | nilotinib 400 mg twice daily (bid). Receives: Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients Achieving Stable Disease (SD)
Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.
Measured: During the first 4 months
Percent of Patients Achieving Partial Response (PR)
The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Measured: during the first 4 months
Percent of Patients Achieving Complete Response (CR)
Complete response (CR) is the Disappearance of all target lesions.
Measured: during the first 4 months
Secondary outcomes (6)
Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population
Complete Response (CR): Disappearance of all target lesions. and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Measured: 24 weeks and 52 weeks
Time to Overall Response (CR or PR): Per Protocol Population
Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Measured: 24 weeks and 52 weeks
Time to Tumor Progression
Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated as stated in section 9.8.3 of the clinical study report.
Measured: during the first 4 months
Duration of Overall Response
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence
Measured: during 12 months
Overall Survival, Number of Events Related to Progression of the Disease
The OS rate could not be calculated due to the high number of censored cases. Number of censored, n (%) 108 (86.4). Only available data is number of events. OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died, survival was censored at date of last contact.
Measured: during 12 months
Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.
Progression-free survival (PFS) is defined as the time from first study drug administration to objective tumor progression or death from any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Measured: during 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startNov 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal Stromal 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 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
- NCT01289028
- Sponsor's protocol ID
- CAMN107DDE05
- Other IDs
- 2008-000357-35, 2008
- Status last verified
- Jun 2016
- First submitted
- 16 Jan 2011
- Last updated
- 2 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
- ClinicalTrials.gov ID
- NCT01289028
- Acronym / sponsor ID
- CAMN107DDE05
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- GIST, Imatinib, Sunitinib, Gastrointestinal, Stromal, Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 1 Nov 2016
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 evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.
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: Nilotinibnilotinib 400 mg twice daily (bid). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent.
- Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)
- At least one measurable site of disease on CT/MRI as defined by RECIST criteria.
Key exclusion criteria (6 listed)
- Prior treatment with nilotinib.
- Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1.
- Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
- Impaired cardiac function at visit 1
- Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.
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 |
|---|---|---|
| NilotinibAlso: AMN107 | Drug | Nilotinib |
Primary outcome
Percent of Patients Achieving Stable Disease (SD)
Time frame: During the first 4 months
Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.
Percent of Patients Achieving Partial Response (PR)
Time frame: during the first 4 months
The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Percent of Patients Achieving Complete Response (CR)
Time frame: during the first 4 months
Complete response (CR) is the Disappearance of all target lesions.
6 secondary outcomes
Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population
Time frame: 24 weeks and 52 weeks
Time to Overall Response (CR or PR): Per Protocol Population
Time frame: 24 weeks and 52 weeks
Time to Tumor Progression
Time frame: during the first 4 months
Duration of Overall Response
Time frame: during 12 months
Overall Survival, Number of Events Related to Progression of the Disease
Time frame: during 12 months
Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.
Time frame: during 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nilotinib in people with Gastrointestinal Stromal Tumors, run by Novartis Pharmaceuticals at 19 sites in 2 countries.
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 6 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 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Patients Achieving Stable Disease (SD) (time frame: During the first 4 months). The study lists 3 primary outcomes in all. 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 2 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.