Gastrointestinal Stromal TumorsPhase 4NCT00756509
Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib
A Phase 4 study testing Nilotinib in people with Gastrointestinal Stromal Tumors, run by Novartis Pharmaceuticals at 10 sites in 5 countries.
Trial summary
The purpose of this multicenter, single-arm, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Nilotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 29 Aug 2008to 18 Dec 2024
- Phase
- Phase 4
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent prior to or at Visit 1
- At least one measurable site of disease on CT/MRI scan at Visit 1, as defined by RECIST criteria. The scans should be at maximum 2 weeks old. New scans are only required as baseline scans if they are older than approx. 2 weeks.
- WHO Performance Status of 0, 1 or 2
- Patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):
- Potassium ≥ LLN,
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- Magnesium ≥ LLN,
- Phosphorus ≥ LLN,
- Total calcium (corrected for serum albumin) ≥ LLN
- Patients must have normal organ, electrolyte, and marrow function as defined below:
- Absolute Neutrophil Count (ANC) ≥ 1.5x 109/L;
- Platelets ≥ 100 x 109/L;
- ALT and AST ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if considered due to tumor;
- Alkaline phosphatase ≤ 2.5 x ULN unless considered due to tumor;
- Serum bilirubin ≤ 1.5 x ULN;
- Serum lipase and amylase ≤ 1.5 x ULN;
- Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min. (calculated creatinine clearance using Cockroft formula is acceptable)
- Ability to understand and willingness to sign a written informed consent
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 with the exception of imatinib targeted therapy as an adjuvant therapy or imatinib in first line treatment for maximum of 4 weeks.
- 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 including any one of the following:
- LVEF < 45% or below the institutional LLN range (whichever is higher) as determined by echocardiogram at Visit 1
- Complete left bundle branch block
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- Use of a ventricular paced cardiac pacemaker
- Congenital long QT syndrome or family history of long QT syndrome
- History of or presence of significant ventricular or atrial tachyarrhythmias
- Clinically significant resting bradycardia (< 50 beats per minute)
- QTc > 450 msec on screening ECG (using the QTcF formula). If QTc > 450 msec and electrolytes are not within normal ranges (electrolytes should be corrected and then the patient rescreened for QTc.
- Right bundle branch block plus left anterior hemiblock, bifascicular block
- Myocardial infarction within 12 months prior to Visit 1
- Other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension,)
- 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
- Use of therapeutic coumarin derivatives (i.e. warfarin, acenoucumarol, phenprocoumon)
- Use of any medications that prolong the QT interval and CYP3A4 inhibitors if the treatment cannot be either safely discontinued or switched to a different medication prior to starting study drug administration. Please see www.qtdrugs.org for a comprehensive list of agents that prolong the QT interval as well as [Post-Text Supplement 2].
- 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
- A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits
- Patients who are pregnant, breast feeding or women of childbearing potential (WOCBP). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential Women of reproductive potential, to include female partners of heterosexual or bisexual patients, must agree to use an effective method of contraception during the study and for up to three months following termination of the study.
- Patients unwilling or unable to comply with the protocol
- Eligibility criteria for patients from studies CAMN107G2301 or CAMN107DDE05 Patients currently participating in the Novartis-sponsored studies CAMN107G2301 or CAMN107DDE05 and benefiting from the nilotinib treatment according to the investigator will be offered the possibility to continue treatment with nilotinib in study CAMN107DDE06.
- They will be included in study CAMN107DDE06 if the following criteria are fulfilled:
- Patient has an histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
- Patient is currently enrolled in the studies CAMN107G2301 or CAMN107DDE05 in Germany and is on treatment with nilotinib
- Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator
- Patient has demonstrated compliance, as assessed by the investigator, within the CAMN107G2301 or CAMN107DDE05 protocols requirements
- Patient has willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
- Written informed consent obtained prior to enrollment in the study
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 30 days of study medication. Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
- Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
- Combination of any two of the following (a+b or a+c, or b+c):
- Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
- In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Sexually active males unless they use a condom during intercourse while taking drug and for 30 days after stopping study medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany4 sites
Novartis Investigative Site
Bad Saarow, 15526
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Munich, Bavaria, 81377
Spain3 sites
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Palma, Balearic Islands, 07120
Novartis Investigative Site
Valencia, Valencia, 46009
About this study
Official title: An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment
The purpose of this multicenter, single-arm, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Read the detailed description
The study planned a 6-month recruitment phase to enroll 40 subjects, followed by a 6-month treatment phase with monthly visits. Patients benefiting from the treatment could continue during a follow-up phase.
On May 5, 2011, Novartis decided to discontinue the ongoing clinical trials with Nilotinib in GIST. This decision was influenced by the discontinuation of the ENESTg1 study (CAMN107G2301), which showed that Nilotinib was unlikely to demonstrate superiority to Imatinib in progression-free survival, the primary endpoint. The independent Data Management Committee (DMC) also reported no safety issues in either trial arm. Following the decision to close-out the Novartis- Sponsored studies CAMN107G2301 (NCT00785785) and CAMN107DDE05 (NCT01289028), the enrollment of the study CAMN107DDE06 was re-opened in order to ensure continued access to nilotinib to the patients currently in the CAMN107G2301 trial and CAMN107DDE05 trial in Germany and benefiting from the nilotinib treatment.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Nilotinib
- Keywords
- unresectable or metastatic GIST, 1st. line treatment
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
800 mg/d orally
| Study group | Role | What they receive |
|---|---|---|
| nilotinib | Experimental | nilotinib Receives: Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Best Overall Response at Month 6 (Core Phase) Determined According to the RECIST v1.0.
The primary efficacy measure is the proportion of patients reaching Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by Month 6, as per RECIST v1.0. Definitions are as follows: CR requires at least two CRs at least four weeks apart before any progression; PR requires two or more PRs at least four weeks apart, without qualifying for CR; SD is at least one SD more than six weeks after treatment start, not qualifying for CR or PR. Progressive Disease (PD) is defined as progression or cancer-related death within 12 weeks of starting treatment, not qualifying for CR, PR, or SD. UNK refers to cases not meeting these criteria, such as absence of confirmed CR/PR, no SD after six weeks, or early progression. The percentage of patients with CR, PR, or SD will be presented with a one-sided exact 90% (or 80% two-sided) confidence interval for the ITT_F group.
Measured: from baseline to month 6, core phase
Secondary outcomes (6)
Proportion of Participants With Objective Response Rate (ORR) at Month 6 (Core Phase) Observed According to RECIST
Objective Response Rate (ORR) is defined as the proportion of patients in whom a complete (CR) or partial (PR) response was observed according to RECIST at month 6.
Measured: from baseline to month 6, core phase
Time to Response (TTR) at Month 6 (Core Phase)
Time to response is defined as the time from start of treatment to the first objective tumor response (PR or CR) observed. Patients who did not achieve a confirmed PR or CR will be censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease).
Measured: from baseline to month 6, core phase
Duration of Response (CR or PR) for Complete Study (Core and Follow-up Phases)
Duration of response is defined as the time from onset of response (CR/PR) to objective tumor progression or death from any cause. Patients not experiencing progression or death will be censored with the date of their last adequate tumor assessment.
Measured: from date of first response (CR or PR) until progression or death, up to data cut off (up to approximately 16 years)
Progression-free Survival (PFS) for Complete Study (Core and Follow-up Phases)
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. PFS will be explored graphically by presenting the Kaplan-Meier curve.
Measured: from date of first response (CR or PR) until progression or death, up to data cut off (up to approximately 16 years)
Overall Survival for Complete Study (Core and Follow-up Phases)
Overall Survival (OS) is defined as the time from first study drug administration to death from any cause. Participants alive at their last known follow-up were censored. No deaths occurred during the study.
Measured: from date of first response (CR or PR) until progression or death, up to data cut off (up to approximately 16 years)
Proportion of Participants With Treatment-emergent Adverse Events During the Entire Study (Core and Follow-up Phases)
This measure summarizes the proportion of participants who experienced at least one treatment-emergent adverse event (TEAE) during the entire study period, including both core and follow-up phases. A TEAE was defined as an adverse event that began or worsened after the first dose of study treatment.
Measured: from the first dose through the end of the study (core and follow-up phases): including all visits up to the follow-up database lock (approximately 16 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study start29 Aug 2008
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT00756509
- Sponsor's protocol ID
- CAMN107DDE06
- Other IDs
- 2008-000358-11, 2008
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2008
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment
- ClinicalTrials.gov ID
- NCT00756509
- Acronym / sponsor ID
- CAMN107DDE06
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- unresectable or metastatic GIST, 1st. line treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2008 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Posted 20 Jan 2026
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 this multicenter, single-arm, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Detailed description
The study planned a 6-month recruitment phase to enroll 40 subjects, followed by a 6-month treatment phase with monthly visits. Patients benefiting from the treatment could continue during a follow-up phase.
On May 5, 2011, Novartis decided to discontinue the ongoing clinical trials with Nilotinib in GIST. This decision was influenced by the discontinuation of the ENESTg1 study (CAMN107G2301), which showed that Nilotinib was unlikely to demonstrate superiority to Imatinib in progression-free survival, the primary endpoint. The independent Data Management Committee (DMC) also reported no safety issues in either trial arm. Following the decision to close-out the Novartis- Sponsored studies CAMN107G2301 (NCT00785785) and CAMN107DDE05 (NCT01289028), the enrollment of the study CAMN107DDE06 was re-opened in order to ensure continued access to nilotinib to the patients currently in the CAMN107G2301 trial and CAMN107DDE05 trial in Germany and benefiting from the nilotinib treatment.
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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥18 years
- Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent prior to or at Visit 1
- At least one measurable site of disease on CT/MRI scan at Visit 1, as defined by RECIST criteria. The scans should be at maximum 2 weeks old. New scans are only required as baseline scans if they are older than approx. 2 weeks.
- WHO Performance Status of 0, 1 or 2
- Patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):
Key exclusion criteria (42 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 with the exception of imatinib targeted therapy as an adjuvant therapy or imatinib in first line treatment for maximum of 4 weeks.
- 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 including any one of the following:
- 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 |
|---|---|---|
| Nilotinib800 mg/d orally | Drug | nilotinib |
Primary outcome
Proportion of Participants With Best Overall Response at Month 6 (Core Phase) Determined According to the RECIST v1.0.
Time frame: from baseline to month 6, core phase
The primary efficacy measure is the proportion of patients reaching Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by Month 6, as per RECIST v1.0. Definitions are as follows: CR requires at least two CRs at least four weeks apart before any progression; PR requires two or more PRs at least four weeks apart, without qualifying for CR; SD is at least one SD more than six weeks after treatment start, not qualifying for CR or PR. Progressive Disease (PD) is defined as progression or cancer-related death within 12 weeks of starting treatment, not qualifying for CR, PR, or SD. UNK refers to cases not meeting these criteria, such as absence of confirmed CR/PR, no SD after six weeks, or early progression. The percentage of patients with CR, PR, or SD will be presented with a one-sided exact 90% (or 80% two-sided) confidence interval for the ITT_F group.
6 secondary outcomes
Proportion of Participants With Objective Response Rate (ORR) at Month 6 (Core Phase) Observed According to RECIST
Time frame: from baseline to month 6, core phase
Time to Response (TTR) at Month 6 (Core Phase)
Time frame: from baseline to month 6, core phase
Duration of Response (CR or PR) for Complete Study (Core and Follow-up Phases)
Time frame: from date of first response (CR or PR) until progression or death, up to data cut off (up to approximately 16 years)
Progression-free Survival (PFS) for Complete Study (Core and Follow-up Phases)
Time frame: from date of first response (CR or PR) until progression or death, up to data cut off (up to approximately 16 years)
Overall Survival for Complete Study (Core and Follow-up Phases)
Time frame: from date of first response (CR or PR) until progression or death, up to data cut off (up to approximately 16 years)
Proportion of Participants With Treatment-emergent Adverse Events During the Entire Study (Core and Follow-up Phases)
Time frame: from the first dose through the end of the study (core and follow-up phases): including all visits up to the follow-up database lock (approximately 16 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nilotinib in people with Gastrointestinal Stromal Tumors, run by Novartis Pharmaceuticals at 10 sites in 5 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 18 inclusion and 42 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Spain, Finland, France, 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 Jan 2026). 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?
Proportion of Participants With Best Overall Response at Month 6 (Core Phase) Determined According to the RECIST v1.0. (time frame: from baseline to month 6, core phase). 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 16 Jul 2026.