GISTPhase 2NCT02015065
Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
A Phase 2 study testing Vandetanib in people with GIST, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: -Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in one of their proteins called succinate dehydrogenase (SDH). Vandetanib is a cancer drug that has been approved to treat thyroid cancer and has been used with some success in other tumors that have a similar loss of… Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- GIST
- What is being tested?
- Vandetanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2013to 10 Dec 2019
- Phase
- Phase 2
- 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 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Presence of any of the following will prevent a subject from participation:
- Pregnant or breast feeding females because vandetanib may be harmful to the developing fetus or nursing infant and has been found to be embryotoxic, fetotoxic and teratogenic in rats.
- Subjects who are receiving any other investigational agents or who have received an investigational agent within 28 days prior to enrollment (does not apply to participation in survival follow up), or who have previous exposure to vandetanib.
- Abnormal Electrolyte Levels: Participants with a serum potassium less than 3.5 mmol/L or a serum ionized calcium or magnesium below the lower limits of normal (or above Common Terminology Criteria in Adverse Events (CTCAE) Grade 1 upper limit). Correction of these electrolyte abnormalities with supplements is allowed. (Serum calcium above the CTCAE Grade 1 upper limit. In cases where the serum calcium is below the normal range, the calcium adjusted for albumin is to be obtained and substituted for the measured serum value. Exclusion is to then be based on the calcium adjusted for albumin values falling below the normal limit: Corrected Calcium = Ca + 0.8 x (4-serum albumin).)
- Presence of hypertension: Diastolic blood pressure above the 95% for age in children (Appendix 2) and > 160 mmHg systolic or >100 mmHg diastolic in adults on at least 2 of 3 measurements with an appropriate-size cuff who are unable to achieve blood pressure control with optimal anti-hypertensive therapy. Patients who are treated with antihypertensive medications with good response are eligible.
- History of Cardiac Disorder:
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- Participants with a history of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation, left bundle branch block) that is symptomatic or requires treatment (except for controlled atrial fibrillation).
- History of any significant cardiac event (e.g. myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease greater than or equal 2 within 12 weeks before starting treatment, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- Participants with a history of congenitally prolonged corrected QT interval (QTc), a first degree relative with unexplained sudden death under 40 years of age, or a measured QTcB (Bazetts correction) longer than 480 msec on electrocardiography (ECG). ECGs should be performed after correction of electrolyte abnormalities. Participants with a prolonged QTcB should have a repeat ECG twice, at least 24 hour apart, and the average of the 3 QTcBs should not exceed 480 msec. History of QT prolongation associated with other medications that required discontinuation of that medication.
- Participants receiving a medication that has a known risk of QTc prolongation or is associated with Torsades de Pointes or any prohibited medications, concomitantly or within 14 days (28 days for levomethadyl) of enrollment.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of vandetanib as evidenced by uncontrolled nausea, vomiting or diarrhea and/or current need for parenteral support with iron or Vitamin B.
- Other clinically severe or uncontrolled systemic illness or any concurrent condition that in the view of the principal investigator could compromise the participant's ability to tolerate vandetanib or could compromise study procedures or endpoints, including interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.
- Unstable brain metastases or spinal cord compression that requires treatment, unless the treatment ended at least 4 weeks before starting treatment and the condition has been stable without steroid treatment for at least 10 days.
- Major surgery (includes surgery that carries significant risk of blood loss, extended periods of general anesthesia, or requires at least an overnight hospital admission) within 28 days before starting treatment.
- Involvement in the planning and/or conduct of the study.
- Previous enrollment in the present study.
- Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Phase II Trial of Vandetanib (ZD6474, Caprelsa(R) in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
Background:
-Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in one of their proteins called succinate dehydrogenase (SDH). Vandetanib is a cancer drug that has been approved to treat thyroid cancer and has been used with some success in other tumors that have a similar loss of SDH. Researchers want to see if this drug can also decrease tumor growth in people with WT-GIST.
Read more
Objectives:
-To test whether the study drug will benefit people with WT-GIST.
Eligibility:
-Adults and children 3 years old and older with WT-GIST.
Design:
- Researchers will test participants tumor tissue to confirm it is the wild type of GIST.
- Participants will be screened with a medical history, physical exam, and blood tests. They will also have electrical recording of the heart (Eastern Cooperative Oncology Group (ECOG)) and scans of the tumor.
- Participants will take the study drug in 28-day cycles. Their doctor will decide how many cycles they can complete.
- They will take the study drug once every day and record it in a diary.
- On Day 14, they will also visit their doctor to look for side effects.
- Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood pressure check, and blood tests. These tests will then be done periodically for as long as they are in the study.
- Before cycle 4, scans will be done to check the size of the cancer. Most of these will be repeated every 3-6 cycles.
- When they stop taking the study drug, participants will return to the clinic for a physical exam and blood tests.
Read the detailed description
Background:
- Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumor of the gastrointestinal tract, resistant to cytotoxic chemotherapy and radiation therapy. KIT and platelet derived growth factor receptor alpha (PDGFRA) mutations have been identified as tumor initiating events in 85% of adult patients with GIST, but 85% of GISTs in pediatric patients lack KIT and PDGFRA mutations (wild-type) and imatinib is not as effective in eliciting objective responses.
- Recent work in the Pediatric and Wild-Type (wt) GIST Clinic at the National Cancer Institute (NCI) led to the identification of succinate dehydrogenase (SDH) germline mutations in 12% patients with wt-GIST (6/34). SDH protein expression evaluated using immunohistochemistry (IHC) was markedly decreased or absent in 18/18 patients with pediatric wt-GIST. Thus the majority of wt-GIST are SDH-deficient. Vandetanib (ZACTIMA; ZD6474; AstraZeneca) is an oral small molecule antineoplastic drug that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), estimated glomerular filtration rate (EGFR), and rearranged during transfection (RET)-dependent signaling. Preliminary preclinical data demonstrate marked growth inhibition of SDH-mutant/deficient renal cell carcinoma cell lines when treated with vandetanib.
Objective(s):
-Primary: To assess the clinical activity (radiographic response Response Evaluation Criteria in Solid Tumors (RECIST v1.1) of vandetanib in children and adults with wt-GIST using RECIST (v1.1).
Eligibility:
-Adults and children with measurable localized or metastatic wt-GIST confirmed in a Clinical Laboratory Improvement Amendments (CLIA) laboratory will be eligible for trial participation. Patients must have measurable disease by RECISTv1.1 and adequate organ function.
Design:
- This phase II trial will determine whether daily oral vandetanib is active in patients with wt-GIST. Vandetanib activity will be assessed primarily by radiographic response of measurable disease using RECISTv1.1.
- Vandetanib will be administered orally once daily continuously in the absence of toxicity or disease progression, using a 28-day cycle.
- Patients will be carefully monitored for toxicity and response. A small, optimal two-stage phase II design with a target response rate of 25% will be used. Nine evaluable patients will be enrolled initially. If 1 or more of the first 9 have a response, then accrual would continue until a total of 24 patients have enrolled. If there are 3 or more responses in 24 (12.5% or more) patients, then this would be sufficiently interesting activity to warrant further study.
- Conditions
- GIST
- Being tested
- Vandetanib
- Keywords
- GIST, Small Molecule, Mesenchymal Tumor, Receptor Tyrosine Kinase, Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VandetanibDrug
Vandetanib administered orally once per day continuously using a 28 day cycle until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Vandetanib in Children | Experimental | Children with measurable localized or metastatic wt-GIST Receives: Drug: Vandetanib |
| Vandetanib in Adults | Experimental | Adults with measurable localized or metastatic wt-GIST Receives: Drug: Vandetanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Clinical Activity-radiographic Response
Clinical activity will be assessed primarily by radiographic response of measurable disease using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease is neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study.
Measured: Every 3 cycles x4 and then every 6 cycles (1 cycle = 28 days) until removal from protocol therapy, an average of 12 months.
Secondary outcomes (4)
Count of Participants With Serious and Non-serious Adverse Events
The count of participants with serious and non-serious adverse events was assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: Date treatment consent signed to date off study, approximately 32 months and 1 day.
Percentage of Participants Overall Survival
Overall survival is defined as the date of on-study to the date of death from any cause or last follow up.
Measured: Overall survival was computed using the number of months from the date of on study to the date of death, an average of 12 months.
Progression Free-Survival
Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Measured: Patients will be evaluated approximately 60 days after last dose of investigational drug until removal of protocol therapy, an average of 12 months.
Maximum Standardized Uptake Value (SUVmax) on Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
The maximum standardized uptake value (SUVmax) was used to measure the uptake of FDG-PET by the Gastrointestinal Tumors.
Measured: Baseline and at a subsequent PET performed on or about day 3-6 of cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start14 Dec 2013
- Primary completion4 May 2016
- Study completion10 Dec 2019
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 GISTStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Brigitte Widemann, M.D., National Cancer Institute (NCI)
- Investigators
- Brigitte C Widemann, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015065
- Sponsor's protocol ID
- 130208
- Other IDs
- 13-C-0208
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2013
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Vandetanib (ZD6474, Caprelsa(R) in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
- ClinicalTrials.gov ID
- NCT02015065
- Acronym / sponsor ID
- 130208
- Conditions
- GIST
- Keywords
- GIST, Small Molecule, Mesenchymal Tumor, Receptor Tyrosine Kinase, Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Dec 2013 (actual)
- Primary completion
- 4 May 2016 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
-Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in one of their proteins called succinate dehydrogenase (SDH). Vandetanib is a cancer drug that has been approved to treat thyroid cancer and has been used with some success in other tumors that have a similar loss of SDH. Researchers want to see if this drug can also decrease tumor growth in people with WT-GIST.
Objectives:
-To test whether the study drug will benefit people with WT-GIST.
Eligibility:
-Adults and children 3 years old and older with WT-GIST.
Design:
- Researchers will test participants tumor tissue to confirm it is the wild type of GIST.
- Participants will be screened with a medical history, physical exam, and blood tests. They will also have electrical recording of the heart (Eastern Cooperative Oncology Group (ECOG)) and scans of the tumor.
- Participants will take the study drug in 28-day cycles. Their doctor will decide how many cycles they can complete.
- They will take the study drug once every day and record it in a diary.
- On Day 14, they will also visit their doctor to look for side effects.
- Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood pressure check, and blood tests. These tests will then be done periodically for as long as they are in the study.
- Before cycle 4, scans will be done to check the size of the cancer. Most of these will be repeated every 3-6 cycles.
- When they stop taking the study drug, participants will return to the clinic for a physical exam and blood tests.
Detailed description
Background:
- Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumor of the gastrointestinal tract, resistant to cytotoxic chemotherapy and radiation therapy. KIT and platelet derived growth factor receptor alpha (PDGFRA) mutations have been identified as tumor initiating events in 85% of adult patients with GIST, but 85% of GISTs in pediatric patients lack KIT and PDGFRA mutations (wild-type) and imatinib is not as effective in eliciting objective responses.
- Recent work in the Pediatric and Wild-Type (wt) GIST Clinic at the National Cancer Institute (NCI) led to the identification of succinate dehydrogenase (SDH) germline mutations in 12% patients with wt-GIST (6/34). SDH protein expression evaluated using immunohistochemistry (IHC) was markedly decreased or absent in 18/18 patients with pediatric wt-GIST. Thus the majority of wt-GIST are SDH-deficient. Vandetanib (ZACTIMA; ZD6474; AstraZeneca) is an oral small molecule antineoplastic drug that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), estimated glomerular filtration rate (EGFR), and rearranged during transfection (RET)-dependent signaling. Preliminary preclinical data demonstrate marked growth inhibition of SDH-mutant/deficient renal cell carcinoma cell lines when treated with vandetanib.
Objective(s):
-Primary: To assess the clinical activity (radiographic response Response Evaluation Criteria in Solid Tumors (RECIST v1.1) of vandetanib in children and adults with wt-GIST using RECIST (v1.1).
Eligibility:
-Adults and children with measurable localized or metastatic wt-GIST confirmed in a Clinical Laboratory Improvement Amendments (CLIA) laboratory will be eligible for trial participation. Patients must have measurable disease by RECISTv1.1 and adequate organ function.
Design:
- This phase II trial will determine whether daily oral vandetanib is active in patients with wt-GIST. Vandetanib activity will be assessed primarily by radiographic response of measurable disease using RECISTv1.1.
- Vandetanib will be administered orally once daily continuously in the absence of toxicity or disease progression, using a 28-day cycle.
- Patients will be carefully monitored for toxicity and response. A small, optimal two-stage phase II design with a target response rate of 25% will be used. Nine evaluable patients will be enrolled initially. If 1 or more of the first 9 have a response, then accrual would continue until a total of 24 patients have enrolled. If there are 3 or more responses in 24 (12.5% or more) patients, then this would be sufficiently interesting activity to warrant further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vandetanib in Children | Experimental | Drug: VandetanibChildren with measurable localized or metastatic wt-GIST |
| Vandetanib in Adults | Experimental | Drug: VandetanibAdults with measurable localized or metastatic wt-GIST |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Pregnant or breast feeding females because vandetanib may be harmful to the developing fetus or nursing infant and has been found to be embryotoxic, fetotoxic and teratogenic in rats.
- Subjects who are receiving any other investigational agents or who have received an investigational agent within 28 days prior to enrollment (does not apply to participation in survival follow up), or who have previous exposure to vandetanib.
- Abnormal Electrolyte Levels: Participants with a serum potassium less than 3.5 mmol/L or a serum ionized calcium or magnesium below the lower limits of normal (or above Common Terminology Criteria in Adverse Events (CTCAE) Grade 1 upper limit). Correction of these electrolyte abnormalities with supplements is allowed. (Serum calcium above the CTCAE Grade 1 upper limit. In cases where the serum calcium is below the normal range, the calcium adjusted for albumin is to be obtained and substituted for the measured serum value. Exclusion is to then be based on the calcium adjusted for albumin values falling below the normal limit: Corrected Calcium = Ca + 0.8 x (4-serum albumin).)
- Presence of hypertension: Diastolic blood pressure above the 95% for age in children (Appendix 2) and > 160 mmHg systolic or >100 mmHg diastolic in adults on at least 2 of 3 measurements with an appropriate-size cuff who are unable to achieve blood pressure control with optimal anti-hypertensive therapy. Patients who are treated with antihypertensive medications with good response are eligible.
- Participants with a history of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation, left bundle branch block) that is symptomatic or requires treatment (except for controlled atrial fibrillation).
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 |
|---|---|---|
| VandetanibVandetanib administered orally once per day continuously using a 28 day cycle until disease progression or unacceptable toxicity | Drug | Vandetanib in Adults, Vandetanib in Children |
Primary outcome
Number of Participants With a Clinical Activity-radiographic Response
Time frame: Every 3 cycles x4 and then every 6 cycles (1 cycle = 28 days) until removal from protocol therapy, an average of 12 months.
Clinical activity will be assessed primarily by radiographic response of measurable disease using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease is neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study.
4 secondary outcomes
Count of Participants With Serious and Non-serious Adverse Events
Time frame: Date treatment consent signed to date off study, approximately 32 months and 1 day.
Percentage of Participants Overall Survival
Time frame: Overall survival was computed using the number of months from the date of on study to the date of death, an average of 12 months.
Progression Free-Survival
Time frame: Patients will be evaluated approximately 60 days after last dose of investigational drug until removal of protocol therapy, an average of 12 months.
Maximum Standardized Uptake Value (SUVmax) on Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Time frame: Baseline and at a subsequent PET performed on or about day 3-6 of cycle 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Brigitte C Widemann, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vandetanib in people with GIST, run by National Cancer Institute (NCI) at 1 site 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 0 inclusion and 17 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Yes. Results are posted in the registry (first posted 23 Jul 2019). 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?
Number of Participants With a Clinical Activity-radiographic Response (time frame: Every 3 cycles x4 and then every 6 cycles (1 cycle = 28 days) until removal from protocol therapy, an average of 12 months.). 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 30 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.