Neuroendocrine TumorsPhase 2HEPAR_PlusNCT02067988
Holmium-166-radioembolization in NET After Lutetium-177-dotatate; an Efficacy Study
A Phase 2 study testing Holmium-166 microspheres hepatic radioembolization. in people with Neuroendocrine Tumors, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Holmium-166 microspheres hepatic radioembolization.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2014to 1 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have given written informed consent.
- Female or male aged 18 years and over.
- Confirmed histological diagnosis NET, including bronchial carcinoids, and metastatic malignancy with liver metastases without standard therapeutic options for treatment including chemotherapy or surgery.
- Patients must have been treated with 4 cycles of 200 mCi 177Lu-dotatate, the last cycle within 8-12 weeks of 166Ho-RE.
- Life expectancy of 12 weeks or longer.
- World Health Organisation (WHO) Performance status 0-2.
- Liver disease with three or more measurable liver lesions according to the RECIST 1.1 criteria.
- Negative pregnancy test for women of childbearing potential.
Who cannot join
- Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week.
- Radiation therapy within the last 4 weeks before the start of study therapy.
- The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
- Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events grade 2 from previous anti-cancer therapy.
- Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
Show all 21Show fewer
- Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- Leukocytes < 3.0 x 109/l and/or platelet count < 100 x 109/l.
- Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- Pregnancy or nursing (women of child-bearing potential).
- Patients suffering from diseases with an increased chance of liver toxicity.
- Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- Patients who are declared incompetent.
- Previous enrolment in the present study or previous treatment with RE.
- Female patients who are not using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR are less than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy.
- Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner.
- Patients with abnormalities of the bile ducts (such as stents) with an increased chance of infections of the bile ducts (papillotomy and cholecystectomy are allowed). Or evidence of extensive portal hypertension, splenomegaly, ascites or active hepatitis (B and/or C).
- Body weight over 150 kg.
- Severe allergy for i.v. contrast (Visipaque®), used for CT evaluation, pre-treatment angiography and treatment angiography.
- Liver tumour involvement ≥70% as quantified on CT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Hepatic Holmium-166-radioembolization in Patients With Unresectable Liver Metastases of Neuroendocrine Origin, Who Have Been Treated With Lutetium-177-dotatate
Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate will be studied in a non-comparative phase II study. The study is an interventional, treatment, non-randomized, open label, non-comparative, phase II study. 166Ho-RE will be performed via a catheter during angiography.
Read the detailed description
Acronym :
Holmium Embolization Particles for Arterial Radiotherapy Plus 177Lu-dotatate in Salvage NET patients- HEPAR PLUS-trial.
Rationale:
Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease.
Objective:
Primary objectives:
- To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study.
- To establish the safety and toxicity profile of adjuvant 166Ho-RE after systemic treatment with 177Lu-dotatate.
Secondary objectives:
- To evaluate Quality of Life (QoL).
- To evaluate biodistribution / dosimetry.
Study design:
Interventional, treatment, non-randomized, open label, non-comparative, phase II study.
Study population:
Patients with liver metastases of NET will be included in this study (n = 30-48). These male and female patients must be aged ≥18 years. All NET histologies are acceptable, provided no standard therapeutic options are available, such as chemotherapy and surgery.
Intervention:
166Ho-RE will be performed via a catheter during angiography.
Study endpoints:
Primary endpoints:
- Tumour response at 3 months.
- Safety and toxicity profile of 166Ho-RE as adjuvant treatment after 177Lu-dotatate.
Secondary endpoints:
- Changes in tumour markers.
- Quality of Life (QoL).
- Biodistribution / Dosimetry.
Duration of treatment:
The study consists of a screening phase of approximately 2 weeks followed by a treatment phase of approximately 2-3 weeks. Patients will be followed until liver specific tumour progression or death has occurred, to a maximum of 12 months.
Methodology:
A first cohort of 30 patients will be treated with 166Ho-RE. After the first cohort, up to 3 additional cohorts of 6 patients will be treated with 166Ho-RE. The total number of patients treated in the HEPAR PLUS trial will therefore be at least 30 and at most 48 patients, depending on the observed number of responses. Early termination at a response interim analysis (after 30, 36 or 42 patients) is determined by pre-defined boundaries on the number of observed responses. The boundary in favour of treatment effect may be crossed before 30 patients are reached, but then the study will continue to at least 30 patients to allow estimation of the key secondary endpoints.
Number of study centers:
Single center (UMC Utrecht).
Adverse events:
All adverse events will be recorded throughout the study.
Inclusion period:
January 2014 - January 2017
- Conditions
- Neuroendocrine Tumors
- Being tested
- Holmium-166 microspheres hepatic radioembolization.
- Keywords
- Radioembolization, Somatostatin receptor treatment, Neuroendocrine tumors, Liver metastases
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium-166 microspheres hepatic radioembolization.Device
Holmium-166 microspheres hepatic radioembolization.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Holmium-166 microspheres hepatic radioembolization, adjuvant to systemic 177Lu-dotatate. Receives: Device: Holmium-166 microspheres hepatic radioembolization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (RECIST 1.1 Partial plus complete)
To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study
Measured: 3 months
Secondary outcomes (4)
Quality of Life (QoL)
To evaluate QoL using EORTC questionnaire. The impact of treatment on QoL will be compared to tumour response, and other parameters. A questionnaire in the patient's native language will be provided.
Measured: 3 months
Biodistribution
To evaluate biodistribution using CT and quantitative SPECT.
Measured: 3 months
Dosimetry
To evaluate dosimetry using CT and quantitative SPECT. The imaging protocol after injection of 166Ho-PLLA-MS will consist of a dual isotope fusion SPECT/CT protocol.
Measured: 3 months
AD Adverse events
To establish the safety and toxicity profile of treatment with 166Ho-microspheres as an adjuvant treatment after 177Lu-dotatate. This profile will be established using CTCAE (incl. SAE) methodology (CTCAE version 4.03).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marnix Lam, UMC Utrecht
- Investigators
- Marnix G Lam, MD, PhD, Principal investigator, UMC Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067988
- Sponsor's protocol ID
- NL45329.041.13
- Acronym
- HEPAR_Plus
- Status last verified
- Jun 2020
- First submitted
- 13 Feb 2014
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Undecided
Publications
Stella M, van Rooij R, Lam MGEH, de Jong HWAM, Braat AJAT. Automatic healthy liver segmentation for holmium-166 radioembolization dosimetry. EJNMMI Res. 2023 Jul 15;13(1):68. doi: 10.1186/s13550-023-00996-1.
PubMed 37453996Stella M, Braat AJAT, Lam MGEH, de Jong HWAM, van Rooij R. 166Holmium-99mTechnetium dual-isotope imaging: scatter compensation and automatic healthy-liver segmentation for 166Holmium radioembolization dosimetry. EJNMMI Phys. 2022 Apr 21;9(1):30. doi: 10.1186/s40658-022-00459-x.
PubMed 35445948Ebbers SC, Brabander T, Tesselaar MET, Hofland J, Braat MNGJA, Wessels FJ, Barentsz MW, Lam MGEH, Braat AJAT. Inflammatory markers and long term hematotoxicity of holmium-166-radioembolization in liver-dominant metastatic neuroendocrine tumors after initial peptide receptor radionuclide therapy. EJNMMI Res. 2022 Feb 2;12(1):7. doi: 10.1186/s13550-022-00880-4.
PubMed 35107642Stella M, Braat A, Lam M, de Jong H, van Rooij R. Quantitative 166Ho-microspheres SPECT derived from a dual-isotope acquisition with 99mTc-colloid is clinically feasible. EJNMMI Phys. 2020 Jul 14;7(1):48. doi: 10.1186/s40658-020-00317-8.
PubMed 32666401Braat AJAT, Bruijnen RCG, van Rooij R, Braat MNGJA, Wessels FJ, van Leeuwaarde RS, van Treijen MJC, de Herder WW, Hofland J, Tesselaar MET, de Jong HWAM, Lam MGEH. Additional holmium-166 radioembolisation after lutetium-177-dotatate in patients with neuroendocrine tumour liver metastases (HEPAR PLuS): a single-centre, single-arm, open-label, phase 2 study. Lancet Oncol. 2020 Apr;21(4):561-570. doi: 10.1016/S1470-2045(20)30027-9. Epub 2020 Feb 26.
PubMed 32112737Braat AJAT, Kwekkeboom DJ, Kam BLR, Teunissen JJM, de Herder WW, Dreijerink KMA, van Rooij R, Krijger GC, de Jong HWAM, van den Bosch MAAJ, Lam MGEH. Additional hepatic 166Ho-radioembolization in patients with neuroendocrine tumours treated with 177Lu-DOTATATE; a single center, interventional, non-randomized, non-comparative, open label, phase II study (HEPAR PLUS trial). BMC Gastroenterol. 2018 Jun 15;18(1):84. doi: 10.1186/s12876-018-0817-8.
PubMed 29902988
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Hepatic Holmium-166-radioembolization in Patients With Unresectable Liver Metastases of Neuroendocrine Origin, Who Have Been Treated With Lutetium-177-dotatate
- ClinicalTrials.gov ID
- NCT02067988
- Acronym / sponsor ID
- HEPAR_Plus / NL45329.041.13
- Conditions
- Neuroendocrine Tumors
- Keywords
- Radioembolization, Somatostatin receptor treatment, Neuroendocrine tumors, Liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 20 Feb 2014 (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.
Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate will be studied in a non-comparative phase II study. The study is an interventional, treatment, non-randomized, open label, non-comparative, phase II study. 166Ho-RE will be performed via a catheter during angiography.
Detailed description
Acronym :
Holmium Embolization Particles for Arterial Radiotherapy Plus 177Lu-dotatate in Salvage NET patients- HEPAR PLUS-trial.
Rationale:
Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease.
Objective:
Primary objectives:
- To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study.
- To establish the safety and toxicity profile of adjuvant 166Ho-RE after systemic treatment with 177Lu-dotatate.
Secondary objectives:
- To evaluate Quality of Life (QoL).
- To evaluate biodistribution / dosimetry.
Study design:
Interventional, treatment, non-randomized, open label, non-comparative, phase II study.
Study population:
Patients with liver metastases of NET will be included in this study (n = 30-48). These male and female patients must be aged ≥18 years. All NET histologies are acceptable, provided no standard therapeutic options are available, such as chemotherapy and surgery.
Intervention:
166Ho-RE will be performed via a catheter during angiography.
Study endpoints:
Primary endpoints:
- Tumour response at 3 months.
- Safety and toxicity profile of 166Ho-RE as adjuvant treatment after 177Lu-dotatate.
Secondary endpoints:
- Changes in tumour markers.
- Quality of Life (QoL).
- Biodistribution / Dosimetry.
Duration of treatment:
The study consists of a screening phase of approximately 2 weeks followed by a treatment phase of approximately 2-3 weeks. Patients will be followed until liver specific tumour progression or death has occurred, to a maximum of 12 months.
Methodology:
A first cohort of 30 patients will be treated with 166Ho-RE. After the first cohort, up to 3 additional cohorts of 6 patients will be treated with 166Ho-RE. The total number of patients treated in the HEPAR PLUS trial will therefore be at least 30 and at most 48 patients, depending on the observed number of responses. Early termination at a response interim analysis (after 30, 36 or 42 patients) is determined by pre-defined boundaries on the number of observed responses. The boundary in favour of treatment effect may be crossed before 30 patients are reached, but then the study will continue to at least 30 patients to allow estimation of the key secondary endpoints.
Number of study centers:
Single center (UMC Utrecht).
Adverse events:
All adverse events will be recorded throughout the study.
Inclusion period:
January 2014 - January 2017
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Holmium-166 microspheres hepatic radioembolization.Holmium-166 microspheres hepatic radioembolization, adjuvant to systemic 177Lu-dotatate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have given written informed consent.
- Female or male aged 18 years and over.
- Confirmed histological diagnosis NET, including bronchial carcinoids, and metastatic malignancy with liver metastases without standard therapeutic options for treatment including chemotherapy or surgery.
- Patients must have been treated with 4 cycles of 200 mCi 177Lu-dotatate, the last cycle within 8-12 weeks of 166Ho-RE.
- Life expectancy of 12 weeks or longer.
Key exclusion criteria (21 listed)
- Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week.
- Radiation therapy within the last 4 weeks before the start of study therapy.
- The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
- Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events grade 2 from previous anti-cancer therapy.
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 |
|---|---|---|
| Holmium-166 microspheres hepatic radioembolization.Holmium-166 microspheres hepatic radioembolization. | Device | Treatment arm |
Primary outcome
Response (RECIST 1.1 Partial plus complete)
Time frame: 3 months
To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study
4 secondary outcomes
Quality of Life (QoL)
Time frame: 3 months
Biodistribution
Time frame: 3 months
Dosimetry
Time frame: 3 months
AD Adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Derived from this study: PubMed 37453996Stella M, van Rooij R, Lam MGEH, de Jong HWAM, Braat AJAT. Automatic healthy liver segmentation for holmium-166 radioembolization dosimetry. EJNMMI Res. 2023 Jul 15;13(1):68. doi: 10.1186/s13550-023-00996-1.
- Derived from this study: PubMed 35445948Stella M, Braat AJAT, Lam MGEH, de Jong HWAM, van Rooij R. 166Holmium-99mTechnetium dual-isotope imaging: scatter compensation and automatic healthy-liver segmentation for 166Holmium radioembolization dosimetry. EJNMMI Phys. 2022 Apr 21;9(1):30. doi: 10.1186/s40658-022-00459-x.
- Derived from this study: PubMed 35107642Ebbers SC, Brabander T, Tesselaar MET, Hofland J, Braat MNGJA, Wessels FJ, Barentsz MW, Lam MGEH, Braat AJAT. Inflammatory markers and long term hematotoxicity of holmium-166-radioembolization in liver-dominant metastatic neuroendocrine tumors after initial peptide receptor radionuclide therapy. EJNMMI Res. 2022 Feb 2;12(1):7. doi: 10.1186/s13550-022-00880-4.
- Derived from this study: PubMed 32666401Stella M, Braat A, Lam M, de Jong H, van Rooij R. Quantitative 166Ho-microspheres SPECT derived from a dual-isotope acquisition with 99mTc-colloid is clinically feasible. EJNMMI Phys. 2020 Jul 14;7(1):48. doi: 10.1186/s40658-020-00317-8.
- Derived from this study: PubMed 32112737Braat AJAT, Bruijnen RCG, van Rooij R, Braat MNGJA, Wessels FJ, van Leeuwaarde RS, van Treijen MJC, de Herder WW, Hofland J, Tesselaar MET, de Jong HWAM, Lam MGEH. Additional holmium-166 radioembolisation after lutetium-177-dotatate in patients with neuroendocrine tumour liver metastases (HEPAR PLuS): a single-centre, single-arm, open-label, phase 2 study. Lancet Oncol. 2020 Apr;21(4):561-570. doi: 10.1016/S1470-2045(20)30027-9. Epub 2020 Feb 26.
- Derived from this study: PubMed 29902988Braat AJAT, Kwekkeboom DJ, Kam BLR, Teunissen JJM, de Herder WW, Dreijerink KMA, van Rooij R, Krijger GC, de Jong HWAM, van den Bosch MAAJ, Lam MGEH. Additional hepatic 166Ho-radioembolization in patients with neuroendocrine tumours treated with 177Lu-DOTATATE; a single center, interventional, non-randomized, non-comparative, open label, phase II study (HEPAR PLUS trial). BMC Gastroenterol. 2018 Jun 15;18(1):84. doi: 10.1186/s12876-018-0817-8.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Neuroendocrine Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
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.
Marnix G Lam, MD, PhD principal investigator
UMC Utrecht, The Netherlands
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 Holmium-166 microspheres hepatic radioembolization. in people with Neuroendocrine Tumors, run by UMC Utrecht at 1 site in Netherlands.
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 8 inclusion and 21 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 17 Jun 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 Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (RECIST 1.1 Partial plus complete) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067988, which also lists 6 linked publications.
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 17 Jun 2020.