Colorectal Cancer MetastaticPhase 2BEYONDNCT03751176
Second-line FOLFIRI + Panitumumab in Subjects With Wild Type RAS Metastatic Colorectal
A Phase 2 study testing Panitumumab, Irinotecan and Folinic acid in people with Colorectal Cancer Metastatic, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 18 sites in Spain.
Trial summary
To estimate progression-free-survival at 6 months in subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC (metastatic colorectal cancer) confirmed in liquid biopsies before starting second line treatment will be screened for this trial and who have interrupted panitumumab for <3… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Panitumumab, Irinotecan and Folinic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 18 sitesSpain
- Study dates
- 8 Nov 2018to 30 Nov 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman at least 18 years old
- Capable of understand, sign and date an informed consent approved by an IEC (investigational Ethics Committee)
- Histologically confirmed adenocarcinoma of the colon or rectum in subjects with metastatic disease
- Having received a 1st line chemotherapy regimen for mCRC consisting of FOLFOX + panitumumab and having at least achieved stable disease ( i.e., CR (Complete Response) PR (Partial Response) or SD (stable disease) )
- Wild-type RAS tumour status confirmed in liquid biopsies before starting second-line treatment
- At least one unidimensionally measurable lesion of at least 10 mm per RECIST criteria (version 1.1)
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- Subjects not candidates for metastasectomy
- Tumour disease staging according to RECIST (version 1.1) by investigator up to 4 weeks prior to start of study treatment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate bone marrow function: neutrophils ≥1.5 x109/ L; platelets ≥100 x109/L; haemoglobin ≥9 g/dL
- Hepatic, renal and metabolic function as follows:
- Total bilirubin count ≤1.5 x upper limit of normal (ULN), ALT (alanine aminotransferase) and AST (aspartate aminotransferase) <2.5 x ULN; or in case of liver metastasis ALT and AST <5 x ULN
- Renal function, calculated as creatinine clearance or 24-hour creatinine clearance ≥ 50 mL/min
- Magnesium > lower limit of normal (LLN) -
Who cannot join
- Diagnosis of progressive disease more than 3 months after the last panitumumab administration
- First-line PFS of less than 3 months
- Subjects given less than 3 months (consecutive) of first-line panitumumab
- History of prior or concurrent central nervous system (CNS) metastases
- History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years before inclusion
- Prior irinotecan therapy
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- Unresolved toxicities of a previous systemic treatment that, in the opinion of the investigator, cause the subject unfit for inclusion
- Prior hormonal therapy, immunotherapy or approved or experimental antibody/proteins ≤ 30 days before inclusion (excluding panitumumab)
- Any investigational agent within 30 days prior to inclusion
- Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computerised tomography
- Acute or subacute intestinal occlusion and/or active inflammatory bowel disease or other bowel disease that causes chronic diarrhoea (defined as grade ≥ 2 diarrhoea according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03)
- Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia
- History of Gilbert disease or known dihydropyrimidine deficiency syndrome
- Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
- Treatment for systemic infection within 14 days before the start of study treatment
- History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results
- Surgery (excluding diagnostic biopsy or placement of a central venous catheter) and/or radiotherapy within 28 days prior to inclusion in the study.
- Pregnant or breastfeeding woman
- Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g., diaphragm plus condoms) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and 1 month for men
- The subject is unwilling or unable to meet the requirements of the study
- Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule. These conditions should be discussed with the subject before inclusion in the trial. -
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital General Universitario de Elche
Alicante, Elche, 03203
Hospital de La Ribera de Alzira
Alzira, Valencia, 46600
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu I Sant Pau
Barcelona, 08041
ICO Girona Dr. Josep Trueta
Girona, Barcelona, 17007
Hospital de Granollers
Granollers, Barcelona, 08402
Hospital 12 de Octubre
Madrid, 28041
Hospital Universtiario la Paz
Madrid, 28046
CIOCC Sanchinarro
Madrid, 28050
Complejo Hospitalario de Navarra
Navarro, 31008
H. Universitari Sant Joan de Reus
Reus, Tarragona, 43204
Corporació Sanitaria Parc Taulí
Sabadell, 08208
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
Fundación Instituto Valenciano de Oncología
Valencia, 46009
Hospital Universitario Dr. Peset
Valencia, 46017
Hospital Universitario y Politécnico La Fe
Valencia, 46026
About this study
Official title: Phase II Clinical Trial to Evaluate the Efficacy of Second-line FOLFIRI + Panitumumab in Subjects With Wild Type RAS Metastatic Colorectal Cancer Who Have Received FOLFOX + Panitumumab in First-line
To estimate progression-free-survival at 6 months in subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC (metastatic colorectal cancer) confirmed in liquid biopsies before starting second line treatment will be screened for this trial and who have interrupted panitumumab for <3 months (panitumumab continuation). Control arm of subjects treated with FOLFIRI alone will be included.
The combinations of 5-fluorouracil (5-FU) with oxaliplatin (FOLFOX)are considered the backbone chemotherapy for mCRC. Clinical trials have shown the benefit of adding monoclonal antibodies to subjects without mutations in RAS, directed against the epidermal growth factor receptor (EGFR) (cetuximab and panitumumab) to conventional chemotherapy as first-line treatment of mCRC. This trial purposes to study the treatment beyond progression with panitumumab in subjects treated in first-line with an anti-EGFR monoclonal antibody, or rather,the re-introduction of the same targeted therapy after progression to first line.
The clinical hypothesis of this study is that the second-line regimen FOLFIRI + panitumumab, is sufficiently active (defined as a 6-months PFS higher than 30% [based on prior results with second-line FOLFIRI alone] and of at least 50%), justifying further study in this population.
Read the detailed description
A phase II, multicentre, open-label, randomized two-arm study. Subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC confirmed in liquid biopsies before starting second line treatment will be screened for this trial. Only subjects who have interrupted panitumumab for < 3 months (panitumumab continuation) will be included.
Eligible subjects will receive FOLFIRI + panitumumab until disease progression, onset of unacceptable drug toxicities, or subject/physician's request to discontinue. A control arm of subjects treated with FOLFIRI alone will be included. Subjects will be assigned in a 3:2 ratio to receive FOLFIRI + panitumumab (Group A) or FOLFIRI alone (Group B). Randomization will be stratified by primary tumour location (left vs right). A blood sample will be obtained at baseline and at disease progression in order to determine the mutational status of RAS/BRAF and other biomarkers.
Tumour response assessment will be performed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1). Subjects will be evaluated for tumour response every 8 weeks until documentation of disease progression. Responding disease will be confirmed no less than 28 days after the criteria for response are first met. Subjects with symptoms suggestive of progressive disease should be evaluated for tumour progression at the time the symptoms occur. After second-line treatment discontinuation, information on subsequent lines of treatments at the physician discretion and survival will be collected in follow-up visits carried out every 12 weeks (± 4 weeks) until the end of the study (approximately 20 months after the inclusion of the last subject in the study).
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Panitumumab, Irinotecan, Folinic acid, 5-FU
- Keywords
- Clinical trial, phase II, Aged (at least 18 years old), Progression -Free - Survival, Safety, Conversion rate of RAS/BRAF status in liquid biopsy, Chemotherapy regimen, Monoclonal antibody, FOLFIRI, Panitumumab, RAS/BRAF Wild-type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Vectibix
Panitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy
IrinotecanDrug
Also called Any marketed
Irinotecan 180 mg/m2 will be administered as IV infusion over 90 min on day 1
Folinic acidDrug
Also called Any marketed, Leucovorin
Folinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1
5-FUDrug
Also called Any marketed, 5-fluorouracil
5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI + panitumumab | Experimental | Patients received panitumumab plus FOLFIRI in 14-day cycles until disease progression, unacceptable toxicity, investigator's decision or patient withdrawal of consent, at the following doses:
* Panitumumab: 6 mg/kg administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy
* FOLFIRI:
* Irinotecan: 180 mg/m2 as IV infusion over 90 min on day 1
* Folinic acid: (leucovorin) 200-400 mg/m2 IV over 2 hours on day 1
* 5-FU: 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2 Receives: Drug: Panitumumab; Drug: Irinotecan; Drug: Folinic acid; Drug: 5-FU |
| FOLFIRI | Active comparator | Patients received FOLFIRI in 14-day cycles until disease progression, unacceptable toxicity, investigator's decision or patient withdrawal of consent, at the following doses:
* Irinotecan: 180 mg/m2 as IV infusion over 90 min on day 1
* Folinic acid: (leucovorin) 200-400 mg/m2 IV over 2 hours on day 1
* 5-FU: 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2 Receives: Drug: Irinotecan; Drug: Folinic acid; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 6 months
The proportion of subjects progression free at 6 months
Measured: 6 months after inclusion
Secondary outcomes (5)
Progression-free survival (PFS)
Time from randomization to progression or death (Kaplan-Meier estimate)
Measured: 38 months
Overall response rate (ORR)
Proportion of subjects with an objective response (complete or partial response) per RECIST 1.1 criteria
Measured: 38 months
Overall survival (OS)
Time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cut-off date censored at their last contact date (Kaplan-Meier estimate)
Measured: 38 months
Safety and tolerability. ( assessment will consist of monitoring adverse events (AEs), including serious adverse events (SAEs) and laboratory safety parameters)
Safety assessment will consist of monitoring adverse events (AEs), including serious adverse events (SAEs) and laboratory safety parameters. AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Measured: 38 months
Biomarkers analysis by liquid biopsies.
Conversion rate of RAS/BRAF status according to liquid biopsy determinations at second-line treatment initiation and at the time of disease progression after second-line treatment
Measured: 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start8 Nov 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Model description
- Subjects will be assigned in a 3:2 ratio to receive FOLFIRI + panitumumab (Group A) or FOLFIRI alone (Group B). Randomization will be stratified by primary tumour location (left vs right).
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Pivotal S.L.
- Responsible party
- Sponsor
- Investigators
- Jorge Aparicio, MD, Study director, Hospital universitari i Politecnic La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751176
- Sponsor's protocol ID
- GEMCAD-17-01
- Other IDs
- 2017-004519-38, 2017
- Acronym
- BEYOND
- Status last verified
- Jun 2021
- First submitted
- 20 Nov 2018
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Evaluate the Efficacy of Second-line FOLFIRI + Panitumumab in Subjects With Wild Type RAS Metastatic Colorectal Cancer Who Have Received FOLFOX + Panitumumab in First-line
- ClinicalTrials.gov ID
- NCT03751176
- Acronym / sponsor ID
- BEYOND / GEMCAD-17-01
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Clinical trial, phase II, Aged (at least 18 years old), Progression -Free - Survival, Safety, Conversion rate of RAS/BRAF status in liquid biopsy, Chemotherapy regimen, Monoclonal antibody, FOLFIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer DigestivoUniversity, hospital or other
- Collaborators
- Amgen, Pivotal S.L.
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 23 Nov 2018 (actual)
- 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.
To estimate progression-free-survival at 6 months in subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC (metastatic colorectal cancer) confirmed in liquid biopsies before starting second line treatment will be screened for this trial and who have interrupted panitumumab for <3 months (panitumumab continuation). Control arm of subjects treated with FOLFIRI alone will be included.
The combinations of 5-fluorouracil (5-FU) with oxaliplatin (FOLFOX)are considered the backbone chemotherapy for mCRC. Clinical trials have shown the benefit of adding monoclonal antibodies to subjects without mutations in RAS, directed against the epidermal growth factor receptor (EGFR) (cetuximab and panitumumab) to conventional chemotherapy as first-line treatment of mCRC. This trial purposes to study the treatment beyond progression with panitumumab in subjects treated in first-line with an anti-EGFR monoclonal antibody, or rather,the re-introduction of the same targeted therapy after progression to first line.
The clinical hypothesis of this study is that the second-line regimen FOLFIRI + panitumumab, is sufficiently active (defined as a 6-months PFS higher than 30% [based on prior results with second-line FOLFIRI alone] and of at least 50%), justifying further study in this population.
Detailed description
A phase II, multicentre, open-label, randomized two-arm study. Subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC confirmed in liquid biopsies before starting second line treatment will be screened for this trial. Only subjects who have interrupted panitumumab for < 3 months (panitumumab continuation) will be included.
Eligible subjects will receive FOLFIRI + panitumumab until disease progression, onset of unacceptable drug toxicities, or subject/physician's request to discontinue. A control arm of subjects treated with FOLFIRI alone will be included. Subjects will be assigned in a 3:2 ratio to receive FOLFIRI + panitumumab (Group A) or FOLFIRI alone (Group B). Randomization will be stratified by primary tumour location (left vs right). A blood sample will be obtained at baseline and at disease progression in order to determine the mutational status of RAS/BRAF and other biomarkers.
Tumour response assessment will be performed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1). Subjects will be evaluated for tumour response every 8 weeks until documentation of disease progression. Responding disease will be confirmed no less than 28 days after the criteria for response are first met. Subjects with symptoms suggestive of progressive disease should be evaluated for tumour progression at the time the symptoms occur. After second-line treatment discontinuation, information on subsequent lines of treatments at the physician discretion and survival will be collected in follow-up visits carried out every 12 weeks (± 4 weeks) until the end of the study (approximately 20 months after the inclusion of the last subject in the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be assigned in a 3:2 ratio to receive FOLFIRI + panitumumab (Group A) or FOLFIRI alone (Group B). Randomization will be stratified by primary tumour location (left vs right).
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI + panitumumab | Experimental | Drug: Panitumumab, Drug: Irinotecan, Drug: Folinic acid, Drug: 5-FUPatients received panitumumab plus FOLFIRI in 14-day cycles until disease progression, unacceptable toxicity, investigator's decision or patient withdrawal of consent, at the following doses: * Panitumumab: 6 mg/kg administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy * FOLFIRI: * Irinotecan: 180 mg/m2 as IV infusion over 90 min on day 1 * Folinic acid: (leucovorin) 200-400 mg/m2 IV over 2 hours on day 1 * 5-FU: 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2 |
| FOLFIRI | Active comparator | Drug: Irinotecan, Drug: Folinic acid, Drug: 5-FUPatients received FOLFIRI in 14-day cycles until disease progression, unacceptable toxicity, investigator's decision or patient withdrawal of consent, at the following doses: * Irinotecan: 180 mg/m2 as IV infusion over 90 min on day 1 * Folinic acid: (leucovorin) 200-400 mg/m2 IV over 2 hours on day 1 * 5-FU: 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Man or woman at least 18 years old
- Capable of understand, sign and date an informed consent approved by an IEC (investigational Ethics Committee)
- Histologically confirmed adenocarcinoma of the colon or rectum in subjects with metastatic disease
- Having received a 1st line chemotherapy regimen for mCRC consisting of FOLFOX + panitumumab and having at least achieved stable disease ( i.e., CR (Complete Response) PR (Partial Response) or SD (stable disease) )
- Wild-type RAS tumour status confirmed in liquid biopsies before starting second-line treatment
Key exclusion criteria (22 listed)
- Diagnosis of progressive disease more than 3 months after the last panitumumab administration
- First-line PFS of less than 3 months
- Subjects given less than 3 months (consecutive) of first-line panitumumab
- History of prior or concurrent central nervous system (CNS) metastases
- History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years before inclusion
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 |
|---|---|---|
| PanitumumabAlso: VectibixPanitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy | Drug | FOLFIRI + panitumumab |
| IrinotecanAlso: Any marketedIrinotecan 180 mg/m2 will be administered as IV infusion over 90 min on day 1 | Drug | FOLFIRI, FOLFIRI + panitumumab |
| Folinic acidAlso: Any marketed, LeucovorinFolinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1 | Drug | FOLFIRI, FOLFIRI + panitumumab |
| 5-FUAlso: Any marketed, 5-fluorouracil5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2 | Drug | FOLFIRI, FOLFIRI + panitumumab |
Primary outcome
Progression-free survival at 6 months
Time frame: 6 months after inclusion
The proportion of subjects progression free at 6 months
5 secondary outcomes
Progression-free survival (PFS)
Time frame: 38 months
Overall response rate (ORR)
Time frame: 38 months
Overall survival (OS)
Time frame: 38 months
Safety and tolerability. ( assessment will consist of monitoring adverse events (AEs), including serious adverse events (SAEs) and laboratory safety parameters)
Time frame: 38 months
Biomarkers analysis by liquid biopsies.
Time frame: 38 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- GEMCAD (Grupo Español Multidisciplinar en Cancer Digestivo) 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.
Jorge Aparicio, MD study director
Hospital universitari i Politecnic La Fe
18 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 Panitumumab, Irinotecan and Folinic acid in people with Colorectal Cancer Metastatic, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 18 sites in Spain.
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 14 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. 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?
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?
Progression-free survival at 6 months (time frame: 6 months after inclusion). 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 Jun 2021.