Metastatic Colorectal CancerPhase 1/2IMPACT-CRCNCT02117466
Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer
A Phase 1/2 study testing Dose escalation cetuximab and Standard dose cetuximab in people with Metastatic Colorectal Cancer, run by Amsterdam UMC, location VUmc at 3 sites in Netherlands.
Trial summary
In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in extra-hepatic colorectal metastases. The investigators hypothesize that uptake of 89Zr-cetuximab is required for response to cetuximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Dose escalation cetuximab and Standard dose cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 3 sitesNetherlands
- Study dates
- Apr 2014to Jan 2021
- Phase
- Phase 1/2
- 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
- Subjects are eligible if they meet the following criteria:
- Advanced colorectal adenocarcinoma
- Subjects must have been treated according to standard care with palliative chemotherapy including a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs.
- No local treatment options
- Life expectancy of at least 12 weeks.
- Age => 18 years.
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- Histological or cytological documentation of cancer is required.
- Tumor material must be tested wild type for the K-RAS (codon 12, 13, 61, 117, 146) and N-RAS (codon 12, 13, 61, 117, 146) genes.
- Subjects have at least one measurable lesion ≥ 2 cm outside the liver. Lesions must be evaluable by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1 or 2
- Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to start of treatment:
- Total bilirubin ≤ 1.5 times the upper limit of normal
- ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 2.5 times upper limit of normal (≤ 5 times upper limit of normal for subjects with liver involvement of their cancer)
- Serum creatinin ≤ 1.5 times upper limit of normal or a calculated creatinin clearance => 50 ml/min
- Signed informed consent must be obtained prior to any study specific procedures.
Who cannot join
- Subjects who meet the following criteria at the time of screening will be excluded:
- Previous exposure to an anti-EGFR therapy
- Significant skin condition interfering with treatment
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
- Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
- Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be allowed.
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- Major surgery within 28 days of start of study drug.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
VU medical centre
Amsterdam, 1007 MB
University Medical Centre Groningen
Groningen, 9700 RB
Radboud University Medical Centre Nijmegen
Nijmegen, Gelderland, 6500 HB
About this study
In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in extra-hepatic colorectal metastases. The investigators hypothesize that uptake of 89Zr-cetuximab is required for response to cetuximab. If no uptake is present the investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET.
The investigators will evaluate the clinical benefit rate of cetuximab in the patients with and without uptake. The ultimate goal is to create a selection tool that can predict response of cetuximab.
Read the detailed description
Rationale: Currently, third line systemic treatment for patients with advanced, wild type K-RAS and as has recently been demonstrated with wild type N-RAS (thereafter referred to as wild type RAS) colorectal cancer (CRC) includes epidermal growth factor receptor (EGFR) inhibition with the anti-EGFR antibody cetuximab. This type of treatment has a modest but significant beneficial activity in this patient group with improved progression-free and overall survival. Although it is known that patients with advanced wild type RAS CRC will not respond to anti-EGFR treatment, it is not understood why patients with wild type RAS CRC do not all benefit from this type of therapy. Apart from other potential gene mutations involved in response to treatment, differences in the variability of pharmacokinetics may play a crucial role in the response to anti-EGFR treatment. In non-responders insufficient drug accumulation may occur in the tumor due to pharmacokinetic processes, such as cetuximab sequestration in the liver which expresses high levels of EGFR, or due to low levels of EGFR expression in tumor lesions. Our main hypothesis is that uptake of cetuximab in metastases is required for response and that achieving cetuximab uptake by increasing its dose will result in improved clinical benefit in patients with advanced CRC with wild type RAS.
Objectives:
PART I:
- to demonstrate 89Zr-cetuximab uptake in non-hepatic metastases at standard dose or at cohort wise increased cetuximab doses (dose escalation).
- to determine the association between 89Zr-cetuximab uptake in non-hepatic metastases and treatment response.
PART II To determine the response rate with an optimized dose of cetuximab as has been selected in part 1 in patients without 89Zr-cetuximab tumor uptake at standard dose of cetuximab (dose extension).
Study design: This is a multicentre non-randomized intervention study; phase I-II dose escalation/extension study.
Study population: Patients with histopathologically confirmed advanced CRC with wild type RAS, without local treatment options, aged ≥ 18 years, with a life expectancy of at least 12 weeks, who are candidates for anti-EGFR antibody monotherapy (3rd line palliative treatment).
Intervention: In the first part we will perform an exploratory PET study in patients with metastasized, RAS wild type CRC without local treatment options, who will be treated with cetuximab. We hypothesize that uptake of 89Zr-cetuximab in metastases is required for response to cetuximab. We will analyze targeting of 89Zr-cetuximab to metastases and the association between 89Zr-cetuximab tumor uptake and tumor response. Early response evaluation will be done with 18F-FDG PET. In a subgroup of 20 patients with metastasis within the field of view (18 cm) including the heart, tumor perfusion will be measured with 15O-water PET scans. In addition, we will investigate the hypothesis that increasing the cetuximab dose results in uptake in patients without uptake in metastases of 89Zr-cetuximab when cetuximab is given at the standard dose regimen. In the second part we will study whether dose adjustments based on 89Zr-cetuximab targeting results in an improved response and clinical benefit rate. In addition, EGFR expression and saturation with cetuximab is studied in tumor biopsies obtained during treatment. Molecular pathways activated by EGFR and kinase activities as well as phosphoproteomics will be studied in tumor biopsies and skin biopsies before and after start of treatment. In addition, the relation of microRNA (miRNA) and peptide profiles in relation to response to therapy will be studied.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Dose escalation cetuximab, Standard dose cetuximab
- Keywords
- cetuximab, PET-imaging
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation cetuximabDrug
dose escalation of cetuximab (described in the second arm)
Standard dose cetuximabDrug
500mg/m2 bsa cetuximab (described in the first arm)
| Study group | Role | What they receive |
|---|---|---|
| Standard dose cetuximab | Other | Uptake of 89Zr-cetuximab: continue standard dose (500mg/m2 bsa) (standard care) Receives: Drug: Standard dose cetuximab |
| Dose escalation cetuximab | Experimental | No 89Zr-cetuximab uptake: dose escalation in a 3x3 cohort design (with maximal 50% dose increase each cohort; with a maximum of 2000 mg/m2 bsa every two weeks) Receives: Drug: Dose escalation cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake (SUV) of 89Zr-cetuximab in extra-hepatic metastases on PET-scan
Measured: 6 days post injection
Clinical Benefit Rate
Complete response, partial response and stable disease (according to RECIST 1.1) on CT-scan (every 2 months)
Measured: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Secondary outcomes (6)
Early response evaluation with 18F-FDG PET
Compare baseline 18F-FDG PET and the on treatment 18F-FDG PET (after 2 weeks of treatment).
Measured: two weeks after start treatment
Tumor perfusion as early response evaluation (measured with 15O-H2O-PET)
Compare baseline 15O-H2O-PET and the on treatment 15O-H2O-PET (after 2 weeks of treatment).
The 15O-H2O-PET will be done in a subgroup of 20 patients, which have metastases within 18 cm field of view including the heart/ aorta.
Measured: two weeks after start treatment
Overall survival
Measured: From date first cetuximab injection until the date of death (median overall survival 10 months)
Progression Free Survival
First year: CT-scan every 2 months (RECIST 1.1)
After 1 year: CT-scan every 3 months (RECIST 1.1)
Measured: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Skin toxicity and hypomagnesemia as early response marker
Every two weeks, graded according to CTCAE v 4.0
Measured: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Quality of life (QoL) and health related QoL
Graded using:
- EQ-5D-3L (quality of Life questionnaire); every 2 months
- FACT-EGFRI-18 (quality of Life questionnaire, specially for skin toxicity caused by anti-EGFR therapy); every 2 weeks untill week 8, hereafter every two months
Measured: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2021
- Study completionJan 2021
Why it stopped: Primary endpoint could no longer be reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Menke- van der Houven van Oordt, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117466
- Sponsor's protocol ID
- 2013.265
- Other IDs
- 2013-002023-41
- Acronym
- IMPACT-CRC
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2014
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tabernero J, Ciardiello F, Rivera F, Rodriguez-Braun E, Ramos FJ, Martinelli E, Vega-Villegas ME, Rosello S, Liebscher S, Kisker O, Macarulla T, Baselga J, Cervantes A. Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study. Ann Oncol. 2010 Jul;21(7):1537-1545. doi: 10.1093/annonc/mdp549. Epub 2009 Nov 25.
PubMed 19940007Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.
PubMed 19403881Van Cutsem E, Tejpar S, Vanbeckevoort D, Peeters M, Humblet Y, Gelderblom H, Vermorken JB, Viret F, Glimelius B, Gallerani E, Hendlisz A, Cats A, Moehler M, Sagaert X, Vlassak S, Schlichting M, Ciardiello F. Intrapatient cetuximab dose escalation in metastatic colorectal cancer according to the grade of early skin reactions: the randomized EVEREST study. J Clin Oncol. 2012 Aug 10;30(23):2861-8. doi: 10.1200/JCO.2011.40.9243. Epub 2012 Jul 2.
PubMed 22753904
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02117466
- Acronym / sponsor ID
- IMPACT-CRC / 2013.265
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- cetuximab, PET-imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary endpoint could no longer be reached.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Radboud University Medical Center
- Study start
- Apr 2014
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 21 Apr 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.
In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in extra-hepatic colorectal metastases. The investigators hypothesize that uptake of 89Zr-cetuximab is required for response to cetuximab. If no uptake is present the investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET.
The investigators will evaluate the clinical benefit rate of cetuximab in the patients with and without uptake. The ultimate goal is to create a selection tool that can predict response of cetuximab.
Detailed description
Rationale: Currently, third line systemic treatment for patients with advanced, wild type K-RAS and as has recently been demonstrated with wild type N-RAS (thereafter referred to as wild type RAS) colorectal cancer (CRC) includes epidermal growth factor receptor (EGFR) inhibition with the anti-EGFR antibody cetuximab. This type of treatment has a modest but significant beneficial activity in this patient group with improved progression-free and overall survival. Although it is known that patients with advanced wild type RAS CRC will not respond to anti-EGFR treatment, it is not understood why patients with wild type RAS CRC do not all benefit from this type of therapy. Apart from other potential gene mutations involved in response to treatment, differences in the variability of pharmacokinetics may play a crucial role in the response to anti-EGFR treatment. In non-responders insufficient drug accumulation may occur in the tumor due to pharmacokinetic processes, such as cetuximab sequestration in the liver which expresses high levels of EGFR, or due to low levels of EGFR expression in tumor lesions. Our main hypothesis is that uptake of cetuximab in metastases is required for response and that achieving cetuximab uptake by increasing its dose will result in improved clinical benefit in patients with advanced CRC with wild type RAS.
Objectives:
PART I:
- to demonstrate 89Zr-cetuximab uptake in non-hepatic metastases at standard dose or at cohort wise increased cetuximab doses (dose escalation).
- to determine the association between 89Zr-cetuximab uptake in non-hepatic metastases and treatment response.
PART II To determine the response rate with an optimized dose of cetuximab as has been selected in part 1 in patients without 89Zr-cetuximab tumor uptake at standard dose of cetuximab (dose extension).
Study design: This is a multicentre non-randomized intervention study; phase I-II dose escalation/extension study.
Study population: Patients with histopathologically confirmed advanced CRC with wild type RAS, without local treatment options, aged ≥ 18 years, with a life expectancy of at least 12 weeks, who are candidates for anti-EGFR antibody monotherapy (3rd line palliative treatment).
Intervention: In the first part we will perform an exploratory PET study in patients with metastasized, RAS wild type CRC without local treatment options, who will be treated with cetuximab. We hypothesize that uptake of 89Zr-cetuximab in metastases is required for response to cetuximab. We will analyze targeting of 89Zr-cetuximab to metastases and the association between 89Zr-cetuximab tumor uptake and tumor response. Early response evaluation will be done with 18F-FDG PET. In a subgroup of 20 patients with metastasis within the field of view (18 cm) including the heart, tumor perfusion will be measured with 15O-water PET scans. In addition, we will investigate the hypothesis that increasing the cetuximab dose results in uptake in patients without uptake in metastases of 89Zr-cetuximab when cetuximab is given at the standard dose regimen. In the second part we will study whether dose adjustments based on 89Zr-cetuximab targeting results in an improved response and clinical benefit rate. In addition, EGFR expression and saturation with cetuximab is studied in tumor biopsies obtained during treatment. Molecular pathways activated by EGFR and kinase activities as well as phosphoproteomics will be studied in tumor biopsies and skin biopsies before and after start of treatment. In addition, the relation of microRNA (miRNA) and peptide profiles in relation to response to therapy will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose cetuximab | Other | Drug: Standard dose cetuximabUptake of 89Zr-cetuximab: continue standard dose (500mg/m2 bsa) (standard care) |
| Dose escalation cetuximab | Experimental | Drug: Dose escalation cetuximabNo 89Zr-cetuximab uptake: dose escalation in a 3x3 cohort design (with maximal 50% dose increase each cohort; with a maximum of 2000 mg/m2 bsa every two weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Advanced colorectal adenocarcinoma
- Subjects must have been treated according to standard care with palliative chemotherapy including a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs.
- No local treatment options
- Life expectancy of at least 12 weeks.
- Age => 18 years.
Key exclusion criteria (9 listed)
- Previous exposure to an anti-EGFR therapy
- Significant skin condition interfering with treatment
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
- Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
- Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be 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 |
|---|---|---|
| Dose escalation cetuximabdose escalation of cetuximab (described in the second arm) | Drug | Dose escalation cetuximab |
| Standard dose cetuximab500mg/m2 bsa cetuximab (described in the first arm) | Drug | Standard dose cetuximab |
Primary outcome
Uptake (SUV) of 89Zr-cetuximab in extra-hepatic metastases on PET-scan
Time frame: 6 days post injection
Clinical Benefit Rate
Time frame: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Complete response, partial response and stable disease (according to RECIST 1.1) on CT-scan (every 2 months)
6 secondary outcomes
Early response evaluation with 18F-FDG PET
Time frame: two weeks after start treatment
Tumor perfusion as early response evaluation (measured with 15O-H2O-PET)
Time frame: two weeks after start treatment
Overall survival
Time frame: From date first cetuximab injection until the date of death (median overall survival 10 months)
Progression Free Survival
Time frame: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Skin toxicity and hypomagnesemia as early response marker
Time frame: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Quality of life (QoL) and health related QoL
Time frame: From date of first cetuximab injection until the date of first documented progression (median time to progression 2.5 months)
Results and safety
The study was stopped early (reason given: Primary endpoint could no longer be reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Background: PubMed 19940007Tabernero J, Ciardiello F, Rivera F, Rodriguez-Braun E, Ramos FJ, Martinelli E, Vega-Villegas ME, Rosello S, Liebscher S, Kisker O, Macarulla T, Baselga J, Cervantes A. Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study. Ann Oncol. 2010 Jul;21(7):1537-1545. doi: 10.1093/annonc/mdp549. Epub 2009 Nov 25.
- Background: PubMed 19403881Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.
- Background: PubMed 22753904Van Cutsem E, Tejpar S, Vanbeckevoort D, Peeters M, Humblet Y, Gelderblom H, Vermorken JB, Viret F, Glimelius B, Gallerani E, Hendlisz A, Cats A, Moehler M, Sagaert X, Vlassak S, Schlichting M, Ciardiello F. Intrapatient cetuximab dose escalation in metastatic colorectal cancer according to the grade of early skin reactions: the randomized EVEREST study. J Clin Oncol. 2012 Aug 10;30(23):2861-8. doi: 10.1200/JCO.2011.40.9243. Epub 2012 Jul 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dose escalation cetuximab and Standard dose cetuximab in people with Metastatic Colorectal Cancer, run by Amsterdam UMC, location VUmc at 3 sites 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 15 inclusion and 9 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Primary endpoint could no longer be reached.). 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?
Uptake (SUV) of 89Zr-cetuximab in extra-hepatic metastases on PET-scan (time frame: 6 days post injection). The study lists 2 primary outcomes in all. 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 NCT02117466, which also lists 3 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 14 Apr 2021.