Carcinoma, Non-Small-Cell LungPhase 2HighTySyNCT02919462
Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase Expression
A Phase 2 study testing Oral vinorelbine, Cisplatin and Maintenance with Metronomic Oral Vinorelbine in people with Carcinoma, Non-Small-Cell Lung and Secondary, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 5 sites in Italy.
Trial summary
This is an open-label, multicentre, randomized phase II trial. Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS) expression , will be randomly assigned with 1:1 ratio to the following treatment Arms: A. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Secondary, Advanced Stage IIIB
- What is being tested?
- Oral vinorelbine, Cisplatin and Maintenance with Metronomic Oral Vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 5 sitesItaly
- Study dates
- Mar 2016to May 2017
- 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
- Patients must have histologically or cytologically Non-squamous NSCLC, (including those with a non-specified tumor type).
- Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
- TS nuclear H-score ≥ 70 or with TS nuclear and cytoplasmatic H-score ≥ 210.
- Patients at first diagnosis or those with disease recurrence after former surgery are eligible.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan. See section 9.2 and Appendix E for the evaluation of measurable disease.
- At least one target or non-target lesion not previously irradiated according to RECIST version 1.1
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- Male or Female, aged ≥18 years.
- Life expectancy greater than 3 months.
- ECOG performance status ≤2 (see Appendix C).
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/µL
- absolute neutrophil count ≥1,000µL
- platelets ≥100,000/µL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease.
- Prior surgery and/or localised irradiation is permitted if delivered outside to the target lesion.
- Prior adjuvant chemotherapy is permitted if it did not contain vinorelbine and pemetrexed and if administered at least 6 months prior entering the study.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation. Patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require escalating high dose steroids (anti-seizure medications are allowed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed, vinorelbine, cisplatin, carboplatin or other agents used in the study.
Show all 10Show fewer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix or surgically resected prostate cancer with normal PSA);
- NSCLC with EGFR mutation (or not able to use EGFR inhibitor) or with anaplastic lymphoma kinase (ALK) gene translocation (such as EML4-ALK).
- Has a known allergy, hypersensitivity, or contraindication to cisplatin, pemetrexed, or vinorelbine or any components used in their preparation or has a contraindication specified in section 7.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
U.O. Oncologia Medica
Faenza, RA, 48018
Ircc Irst
Meldola, FC, 47014
Ospedale di Piacenza, ASL Piacenza
Piacenza
Claudio Dazzi
Ravenna, RA, 48121
U.O. Oncologia Ospedale degli Infermi
Rimini
About this study
This is an open-label, multicentre, randomized phase II trial.
Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS) expression , will be randomly assigned with 1:1 ratio to the following treatment Arms:
- 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral Vinorelbine until disease progression
- 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease progression
Treatment will be repeated every 21 days .
Read the detailed description
An Open-label, Multicenter, Randomized Phase II Trial of Treatment with Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients affected by stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer with high Thymidylate Synthase (TS)expression After signing the informed consent for TS expression evaluation (see Appendix A), patients will be tested for TS expression status of their tumor tissue.
If TS expression is more than 70 in the nucleus or ≥210 in nucleus and in the cytoplasm of tumor cell, they will be categorized as high TS expression patients, and if it is less, they will be considered as TS-negative.
Study Treatment:
Eligible patients will be randomly assigned to the following treatment Arms:
- Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) + Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles.
Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks).
- Pemetrexed, 500 mg/m2, day 1 + Cisplatin, 75 mg/m2, day 1 every 3 weeks, for 4 cycles.
Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks).
7-10 days before treatment administration, premedication with vitamin B12 1000µg intramuscular injection (every 9 weeks) and folate 1mg every day should be commenced.
The total duration of the study will be 3 years. The enrollment period wil be 2 years and 1 year of follow up. Treatment period: until disease progression, intolerable toxicity or patient refusal.
Number of Subjects :130 patients (65 patients per arm)
Statistical Methodology The primary variable of this study is Disease Control Rate (DCR). According to primary variable, assuming a DCR≥70% for patients with high TS expression treated with cisplatin and vinorelbine and a DCR=44% for patients with high TS expression treated with cisplatin and pemetrexed, considering a 2-tailed alpha=0.05 and beta=0.10, it is necessary to enroll 65 patients per arm (130 patients in total) in a 24-month period and the subsequent 12-month follow-up.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Secondary, Advanced Stage IIIB, High Thymidylate Synthase Expression
- Being tested
- Oral vinorelbine, Cisplatin, Maintenance with Metronomic Oral Vinorelbine, Pemetrexed, Maintenance with Pemetrexed
- Keywords
- Carcinoma, Non-Small-Cell Lung, advanced stage IIIB, high Thymidylate Synthase expression, Treatment, Chemotherapy Naïve Patients, stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer, Cisplatin and Pemetrexed, Cisplatin and Oral Vinorelbine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral vinorelbineDrug
Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) every 3 weeks, for 4 cycles
CisplatinDrug
Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles
Maintenance with Metronomic Oral VinorelbineDrug
Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks).
PemetrexedDrug
Pemetrexed, 500 mg/m2, day 1 every 3 weeks, for 4 cycles
CisplatinDrug
Cisplatin 75 mg/m2, day 1 every 3 weeks, for 4 cycles
Maintenance with PemetrexedDrug
Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) + Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles.
Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks). Receives: Drug: Oral vinorelbine; Drug: Cisplatin; Drug: Maintenance with Metronomic Oral Vinorelbine |
| Treatment Arm B | Active comparator | Pemetrexed, 500 mg/m2, day 1 + Cisplatin, 75 mg/m2, day 1 every 3 weeks, for 4 cycles.
Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks).
7-10 days before treatment administration, premedication with vitamin B12 1000µg intramuscular injection (every 9 weeks) and folate 1mg every day should be commenced. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Maintenance with Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Rate (DCR; complete response (CR) plus partial response (PR) plus stable disease (SD)). The response is assessed according to the RECIST 1.1 criteria.
Measured: up to 36 months
Secondary outcomes (4)
Toxicity
Toxicity assessed after each cycle using the Common Toxicity Criteria AE (version 4.03)
Measured: up to 36 months
Overall survival (OS) within th 2 arms
Overall Survival (OS) is defined as the observed length of life from study entry to death for any cause or the date of last contact for patients lost to follow up
Measured: up to 36 months
Progression free survival (PFS) within the two arms
Progression free survival (PFS) is the time from the date of randomization to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.
Measured: up to 36 months
optimal TS H-score cutpoint
to define the optimal Thymidylate Synthase expression(TS) H-score cutpoint in cytoplasm and/or nucleus . TS nuclear and cytoplasmic staining will be evaluated by using an intensity scale (0-3) and the percentage of cells in each category, resulting in semiquantitative H scores ranging from 0 to 300 will be calculated. Total TS H-scores will be calculated posthoc as the sum of nuclear and cytoplasm TS H-scores (range 0-600).
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: low recruitement rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Responsible party
- Sponsor
- Investigators
- Claudio Dazzi, MD, Principal investigator, UOC Oncologia Medica - PO di Ravenna - AUSL della Romagna-RAVENNA Viale Randi 5 - 48121 Ravenna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919462
- Sponsor's protocol ID
- IRST162.10
- Other IDs
- 2015-003440-39, 2015
- Acronym
- HighTySy
- Status last verified
- Jan 2018
- First submitted
- 28 Sep 2016
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase Expression
- ClinicalTrials.gov ID
- NCT02919462
- Acronym / sponsor ID
- HighTySy / IRST162.10
- Conditions
- Carcinoma, Non-Small-Cell Lung, Secondary, Advanced Stage IIIB, High Thymidylate Synthase Expression
- Keywords
- Carcinoma, Non-Small-Cell Lung, advanced stage IIIB, high Thymidylate Synthase expression, Treatment, Chemotherapy Naïve Patients, stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer, Cisplatin and Pemetrexed, Cisplatin and Oral Vinorelbine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitement rate
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Study start
- Mar 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 29 Sep 2016 (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 an open-label, multicentre, randomized phase II trial.
Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS) expression , will be randomly assigned with 1:1 ratio to the following treatment Arms:
- 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral Vinorelbine until disease progression
- 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease progression
Treatment will be repeated every 21 days .
Detailed description
An Open-label, Multicenter, Randomized Phase II Trial of Treatment with Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients affected by stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer with high Thymidylate Synthase (TS)expression After signing the informed consent for TS expression evaluation (see Appendix A), patients will be tested for TS expression status of their tumor tissue.
If TS expression is more than 70 in the nucleus or ≥210 in nucleus and in the cytoplasm of tumor cell, they will be categorized as high TS expression patients, and if it is less, they will be considered as TS-negative.
Study Treatment:
Eligible patients will be randomly assigned to the following treatment Arms:
- Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) + Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles.
Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks).
- Pemetrexed, 500 mg/m2, day 1 + Cisplatin, 75 mg/m2, day 1 every 3 weeks, for 4 cycles.
Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks).
7-10 days before treatment administration, premedication with vitamin B12 1000µg intramuscular injection (every 9 weeks) and folate 1mg every day should be commenced.
The total duration of the study will be 3 years. The enrollment period wil be 2 years and 1 year of follow up. Treatment period: until disease progression, intolerable toxicity or patient refusal.
Number of Subjects :130 patients (65 patients per arm)
Statistical Methodology The primary variable of this study is Disease Control Rate (DCR). According to primary variable, assuming a DCR≥70% for patients with high TS expression treated with cisplatin and vinorelbine and a DCR=44% for patients with high TS expression treated with cisplatin and pemetrexed, considering a 2-tailed alpha=0.05 and beta=0.10, it is necessary to enroll 65 patients per arm (130 patients in total) in a 24-month period and the subsequent 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: Oral vinorelbine, Drug: Cisplatin, Drug: Maintenance with Metronomic Oral VinorelbineOral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) + Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles. Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks). |
| Treatment Arm B | Active comparator | Drug: Pemetrexed, Drug: Cisplatin, Drug: Maintenance with PemetrexedPemetrexed, 500 mg/m2, day 1 + Cisplatin, 75 mg/m2, day 1 every 3 weeks, for 4 cycles. Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks). 7-10 days before treatment administration, premedication with vitamin B12 1000µg intramuscular injection (every 9 weeks) and folate 1mg every day should be commenced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must have histologically or cytologically Non-squamous NSCLC, (including those with a non-specified tumor type).
- Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
- TS nuclear H-score ≥ 70 or with TS nuclear and cytoplasmatic H-score ≥ 210.
- Patients at first diagnosis or those with disease recurrence after former surgery are eligible.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan. See section 9.2 and Appendix E for the evaluation of measurable disease.
Key exclusion criteria (10 listed)
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease.
- Prior surgery and/or localised irradiation is permitted if delivered outside to the target lesion.
- Prior adjuvant chemotherapy is permitted if it did not contain vinorelbine and pemetrexed and if administered at least 6 months prior entering the study.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation. Patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require escalating high dose steroids (anti-seizure medications are allowed)
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 |
|---|---|---|
| Oral vinorelbineOral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) every 3 weeks, for 4 cycles | Drug | Treatment Arm A |
| CisplatinCisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles | Drug | Treatment Arm A |
| Maintenance with Metronomic Oral VinorelbineMaintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks). | Drug | Treatment Arm A |
| PemetrexedPemetrexed, 500 mg/m2, day 1 every 3 weeks, for 4 cycles | Drug | Treatment Arm B |
| CisplatinCisplatin 75 mg/m2, day 1 every 3 weeks, for 4 cycles | Drug | Treatment Arm B |
| Maintenance with PemetrexedMaintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks) | Drug | Treatment Arm B |
Primary outcome
Disease Control Rate (DCR)
Time frame: up to 36 months
Rate (DCR; complete response (CR) plus partial response (PR) plus stable disease (SD)). The response is assessed according to the RECIST 1.1 criteria.
4 secondary outcomes
Toxicity
Time frame: up to 36 months
Overall survival (OS) within th 2 arms
Time frame: up to 36 months
Progression free survival (PFS) within the two arms
Time frame: up to 36 months
optimal TS H-score cutpoint
Time frame: up to 36 months
Results and safety
The study was stopped early (reason given: low recruitement rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Claudio Dazzi, MD principal investigator
UOC Oncologia Medica - PO di Ravenna - AUSL della Romagna-RAVENNA Viale Randi 5 - 48121 Ravenna
5 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 Oral vinorelbine, Cisplatin and Maintenance with Metronomic Oral Vinorelbine in people with Carcinoma, Non-Small-Cell Lung and Secondary, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 5 sites in Italy.
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 19 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in 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 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 was stopped early (reason given: low recruitement rate). Results are not available in the source record.
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 36 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 16 Jan 2018.