Metastatic Colorectal CancerPhase 2AIO-KRK-0116NCT04034459
FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab 1st-line in BRAF-mutated mCRC
A Phase 2 study testing Bevacizumab, Irinotecan and Folinic acid in people with Metastatic Colorectal Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Once randomisation has been completed, the study treatment should be started preferably immediately; at the latest within one week following randomisation. The patients will be randomised in a ratio of 1:2 to the following two treatment arms. 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?
- Bevacizumab, Irinotecan and Folinic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2016to 31 Dec 2023
- 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
- Histologically confirmed UICC stage IV adenocarcinoma of the colon or rectum with metastases (metastatic colorectal cancer [mCRC]); metastases primarily non-resectable or surgery refused by the patient
- RAS wild-type tumour status (KRAS and NRAS exons 2, 3, 4) (proven in the primary tumour or metastasis)
- BRAF-mutant (V600E) tumour (proven in the primary tumour or metastasis)
- Age ≥18 years
- ECOG performance status 0-1
- Patients suitable for chemotherapy administration
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- Patient's written declaration of consent obtained
- Estimated life expectancy > 3 months
- Presence of at least one measurable lesion according to the RECIST 1.1 - criteria (chest X-ray in two planes or chest CT and abdominal CT 4 weeks or less before randomisation)
- Primary tumour tissue available and patient consents to storage and molecular and genetic profiling of the tumour material. Molecular profiling of blood samples is optionally performed.
- Females of childbearing potential (FCBP) and men must agree to use effective contraceptive measures (Pearl index <1) for the duration of the study treatment and for at least 6 months after last administration of the study medication. A female subject will be considered to be of child-bearing potential unless she is ≥ 50 years of age as well as has had a natural menopause for at least 2 years or has been surgically sterilised.
- Adequate bone marrow function:
- Leukocytes ≥ 3.0 x 109/L with neutrophils ≥ 1.5 x 109/L
- Thrombocytes ≥ 100 x 109/L,
- Haemoglobin ≥ 5.6 mmol/L (equivalent to 9 g/dL)
- Adequate hepatic function:
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN),
- ALAT and ASAT ≤ 2.5 x ULN (in case of hepatic metastasis, ALAT and ASAT ≤ 5 x ULN)
- INR < 1.5 and aPTT < 1.5 x ULN (patients without anticoagulation). Therapeutic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.
- Adequate renal function:
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50mL/min.
- Adequate cardiac function: ECG and echocardiogram with a LVEF of ≥ 55%
- No previous chemotherapy for metastatic disease (prior radiotherapy of metastasis/metastases without application of chemotherapy permitted provided that no irradiated metastasis is selected as target lesion)
- Time interval since last administration of any previous neoadjuvant/adjuvant chemotherapy or radiochemotherapy ≥6 months
- Any relevant toxicities of previous treatments must have subsided to grade 0
Who cannot join
- Grade III or IV heart failure (NYHA classification)
- Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before randomisation
- Pregnancy (absence of pregnancy has to be ascertained by a beta hCG test) or breast feeding
- Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
- Additional cancer treatment (chemotherapy, radiation, immune therapy or hormone treatment) during the study treatment. Treatments that are conducted as part of an anthroposophical or homeopathic treatment approach, e.g. mistletoe therapy, do not represent an exclusion criterion.
- Previous chemotherapy for the colorectal cancer with exception of chemotherapy or radiochemotherapy given as neoadjuvant or adjuvant treatment with curative intent, completed ≥6 months before entering the study.
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- Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or within a period of 5 half-lives of the substances administered in a clinical study or during an experimental drug treatment prior to inclusion in the study, depending on which period is longest, or simultaneous participation in another clinical study while taking part in the study
- Known hypersensitivity or allergic reaction to any of the following substances: 5-fluorouracil, folinic acid, cetuximab, irinotecan, bevacizumab, oxaliplatin and chemically related substances and/or hypersensitivity to any of the excipients of any of the aforementioned substances
- Known hypersensitivity to CHO (Chinese hamster ovary cells) - cell products or other recombinant human or humanised antibodies
- Patients with confirmed cerebral metastases. In case of clinical suspicion of brain metastases, a cranial CT or MRI must be performed to rule out brain metastases before study inclusion.
- History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea.
- Symptomatic peritoneal carcinosis
- Severe, non-healing wounds, ulcers or bone fractures
- Patients with active infection (including confirmed HIV and/or HBV/HCV infection). In case of clinical suspicion of the presence of HIV or HBV/HCV infection, the latter should be ruled out before study inclusion.
- Requirement for immunisation with live vaccine during the study treatment.
- Uncontrolled hypertension
- Marked proteinuria (nephrotic syndrome)
- Arterial thromboembolism or severe haemorrhage within 6 months prior to randomisation (with the exception of tumour bleeding before tumour resection surgery)
- Haemorrhagic diathesis or tendency towards thrombosis
- Known DPD deficiency (specific screening not required)
- Known glucuronidation deficiency (Gilbert's syndrome) (specific screening not required)
- History of a second malignancy during the 5 years before inclusion in the study or during participation in the study, with the exception of a basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, if these were treated curatively.
- Known history of alcohol or drug abuse
- A significant concomitant disease, in particular chronic hepatic or renal disease, chronic inflammatory or autoimmune diseases, ruling out the patient's participation in the study according to investigator's judgement.
- Absent or restricted legal capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Study to Investigate FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab as First-line Treatment of BRAF-mutated Metastatic Colorectal Cancer
Once randomisation has been completed, the study treatment should be started preferably immediately; at the latest within one week following randomisation.
The patients will be randomised in a ratio of 1:2 to the following two treatment arms.
Read more
Patients in both treatment arms will receive standard chemotherapy with FOLFOXIRI as background treatment, which can be de-escalated to FOLFIRI in case of toxicity.
Standard arm A:
The patient will be treated with FOLFOXIRI plus bevacizumab for up to 12 cycles (24 weeks) or until progression (if the latter occurs before completing the 12 cycles). Within the 12 cycles, the FOLFOXIRI plus bevacizumab regimen may be de-escalated, owing to toxicity, to FOLFIRI and bevacizumab at the treating physician's discretion.
After 12 cycles of the study treatment, a switch to a maintenance regimen with a fluoropyrimidine (5-FU infusion or capecitabine) plus bevacizumab, administered until progression occurs, is recommended. The recommended maintenance phase of the study is not part of the study treatment. However, maintenance therapy will be counted as first-line therapy.
Experimental arm B:
The patient will be treated with FOLFOXIRI plus weekly administration of cetuximab for up to 12 cycles (24 weeks) or until progression (if the latter occurs before completing the 12 cycles). Within the 12 cycles, the FOLFOXIRI plus cetuximab regimen may be de-escalated owing to toxicity, to FOLFIRI and cetuximab at the treating physician's discretion.
After 12 cycles, a switch to a maintenance regimen with 5-FU and cetuximab or with irinotecan and cetuximab, administered until progression occurs, is recommended. The recommended maintenance phase of the study is not part of the study treatment. However, maintenance therapy will be counted as first-line therapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Bevacizumab, Irinotecan, Folinic acid, Oxaliplatin, 5-FU
- Keywords
- FIRE, mCRC, AIO, BRAF, FOLFOXIRI, Cetuximab, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab 5 mg/kg BW iv over 30 to 90* min day 1
IrinotecanDrug
Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
Folinic acidDrug
Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
OxaliplatinDrug
Oxaliplatin 85mg/m² day 1
5-FUDrug
5-FU 3000 mg/m² iv over 48 h days 1-2
CetuximabDrug
Cetuximab initially 400 mg/m² with infusion rate of ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI plus bevacizumab | Active comparator | One cycle (cycle duration 14 days) consists of:
* Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
* Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
* Oxaliplatin 85mg/m² day 1
* 5-FU 3000 mg/m² iv over 48 h days 1-2
* Bevacizumab 5 mg/kg BW iv over 30 to 90* min day 1 *1st administration 90 min.; in case of good tolerability, second administration 60 min.; further administrations 30 min.
Repeat administration every 2 weeks for a maximum of 12 cycles
* Dose adaptation at the treating physician's discretion.
* Switch to the recommended maintenance treatment with fluoropyrimidine and bevacizumab after the 8th cycle (following 2nd staging after baseline) is possible at the treating physician's discretion if response according to RECIST 1.1 (CR or PR) has been achieved. Receives: Drug: Bevacizumab; Drug: Irinotecan; Drug: Folinic acid; Drug: Oxaliplatin; Drug: 5-FU |
| FOLFOXIRI plus cetuximab | Experimental | One cycle (cycle duration 14 days) consists of:
* Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
* Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
* Oxaliplatin 85mg/m² day 1
* 5-FU 3000 mg/m² iv over 48 h days 1-2
* Cetuximab initially 400 mg/m² with infusion rate of ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8
Repeat administration every two weeks up to a maximum of 12 cycles.
* Dose adaptation at the treating physician's discretion.
* Switch to the recommended maintenance treatment with 5-FU and cetuximab or irinotecan and cetuximab after the 8th cycle (following 2nd staging after baseline) is possible at the treating physician's discretion if response according to RECIST 1.1 (CR or PR) has been achieved. Receives: Drug: Irinotecan; Drug: Folinic acid; Drug: Oxaliplatin; Drug: 5-FU; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
(overall response rate) measured in percentage of all treated patients according to RECIST 1.1 criteria
Measured: up to 48 months
Secondary outcomes (7)
Progression Free Survival (PFS)
Investigation of progression-free survival (PFS) from randomisation
Measured: up to 60 months
Overall Survival (OS)
Investigation of overall survival (OS) from randomisation
Measured: up to 60 months
Investigation of Early Tumour Shrinkage (ETS) as early-on-Treatment predictor for treatment
Investigation of early tumour shrinkage (ETS)
Measured: up to 48 months
Investigation of Depth of Response (DpR) to define nadir for tumour response.
Investigation of depth of response (DpR)
Measured: up to 48 months
Investigation of Molecular Biomarkers for Prediction of an Anti-EGFR Treatment
Investigation of molecular biomarkers for prediction of sensitivity and secondary resistance of an anti-EGFR treatment with cetuximab (including tumour biopsies and liquid biopsies from blood samples)
Measured: up to 48 months
Prospective Analysis of Tumour Marker Level Evolution (CEA and CA 19-9)
Investigation of prospective analysis of tumour marker level evolution (CEA and CA 19-9)
Measured: up to 48 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Recording of the safety and tolerability (NCI-CTCAE version 4.03 criteria) of the treatment
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start25 Nov 2016
- Primary completion1 Nov 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
- Investigators
- Volker Heinemann, Prof. Dr., Principal investigator, Medizinische Klinik III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034459
- Sponsor's protocol ID
- FIRE-4.5
- Acronym
- AIO-KRK-0116
- Status last verified
- Nov 2023
- First submitted
- 22 Dec 2017
- Last updated
- 14 Nov 2023
- 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 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study to Investigate FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab as First-line Treatment of BRAF-mutated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04034459
- Acronym / sponsor ID
- AIO-KRK-0116 / FIRE-4.5
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- FIRE, mCRC, AIO, BRAF, FOLFOXIRI, Cetuximab, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Jul 2019 (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.
Once randomisation has been completed, the study treatment should be started preferably immediately; at the latest within one week following randomisation.
The patients will be randomised in a ratio of 1:2 to the following two treatment arms.
Patients in both treatment arms will receive standard chemotherapy with FOLFOXIRI as background treatment, which can be de-escalated to FOLFIRI in case of toxicity.
Standard arm A:
The patient will be treated with FOLFOXIRI plus bevacizumab for up to 12 cycles (24 weeks) or until progression (if the latter occurs before completing the 12 cycles). Within the 12 cycles, the FOLFOXIRI plus bevacizumab regimen may be de-escalated, owing to toxicity, to FOLFIRI and bevacizumab at the treating physician's discretion.
After 12 cycles of the study treatment, a switch to a maintenance regimen with a fluoropyrimidine (5-FU infusion or capecitabine) plus bevacizumab, administered until progression occurs, is recommended. The recommended maintenance phase of the study is not part of the study treatment. However, maintenance therapy will be counted as first-line therapy.
Experimental arm B:
The patient will be treated with FOLFOXIRI plus weekly administration of cetuximab for up to 12 cycles (24 weeks) or until progression (if the latter occurs before completing the 12 cycles). Within the 12 cycles, the FOLFOXIRI plus cetuximab regimen may be de-escalated owing to toxicity, to FOLFIRI and cetuximab at the treating physician's discretion.
After 12 cycles, a switch to a maintenance regimen with 5-FU and cetuximab or with irinotecan and cetuximab, administered until progression occurs, is recommended. The recommended maintenance phase of the study is not part of the study treatment. However, maintenance therapy will be counted as first-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI plus bevacizumab | Active comparator | Drug: Bevacizumab, Drug: Irinotecan, Drug: Folinic acid, Drug: Oxaliplatin, Drug: 5-FUOne cycle (cycle duration 14 days) consists of: * Irinotecan 150 mg/m² iv, 30 - 90 min. day 1 * Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1 * Oxaliplatin 85mg/m² day 1 * 5-FU 3000 mg/m² iv over 48 h days 1-2 * Bevacizumab 5 mg/kg BW iv over 30 to 90* min day 1 *1st administration 90 min.; in case of good tolerability, second administration 60 min.; further administrations 30 min. Repeat administration every 2 weeks for a maximum of 12 cycles * Dose adaptation at the treating physician's discretion. * Switch to the recommended maintenance treatment with fluoropyrimidine and bevacizumab after the 8th cycle (following 2nd staging after baseline) is possible at the treating physician's discretion if response according to RECIST 1.1 (CR or PR) has been achieved. |
| FOLFOXIRI plus cetuximab | Experimental | Drug: Irinotecan, Drug: Folinic acid, Drug: Oxaliplatin, Drug: 5-FU, Drug: CetuximabOne cycle (cycle duration 14 days) consists of: * Irinotecan 150 mg/m² iv, 30 - 90 min. day 1 * Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1 * Oxaliplatin 85mg/m² day 1 * 5-FU 3000 mg/m² iv over 48 h days 1-2 * Cetuximab initially 400 mg/m² with infusion rate of ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8 Repeat administration every two weeks up to a maximum of 12 cycles. * Dose adaptation at the treating physician's discretion. * Switch to the recommended maintenance treatment with 5-FU and cetuximab or irinotecan and cetuximab after the 8th cycle (following 2nd staging after baseline) is possible at the treating physician's discretion if response according to RECIST 1.1 (CR or PR) has been achieved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically confirmed UICC stage IV adenocarcinoma of the colon or rectum with metastases (metastatic colorectal cancer [mCRC]); metastases primarily non-resectable or surgery refused by the patient
- RAS wild-type tumour status (KRAS and NRAS exons 2, 3, 4) (proven in the primary tumour or metastasis)
- BRAF-mutant (V600E) tumour (proven in the primary tumour or metastasis)
- Age ≥18 years
- ECOG performance status 0-1
Key exclusion criteria (25 listed)
- Grade III or IV heart failure (NYHA classification)
- Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before randomisation
- Pregnancy (absence of pregnancy has to be ascertained by a beta hCG test) or breast feeding
- Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
- Additional cancer treatment (chemotherapy, radiation, immune therapy or hormone treatment) during the study treatment. Treatments that are conducted as part of an anthroposophical or homeopathic treatment approach, e.g. mistletoe therapy, do not represent an exclusion criterion.
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 |
|---|---|---|
| BevacizumabBevacizumab 5 mg/kg BW iv over 30 to 90* min day 1 | Drug | FOLFOXIRI plus bevacizumab |
| IrinotecanIrinotecan 150 mg/m² iv, 30 - 90 min. day 1 | Drug | FOLFOXIRI plus bevacizumab, FOLFOXIRI plus cetuximab |
| Folinic acidFolinic acid (racemic) 400 mg/m² iv, 120 min. day 1 | Drug | FOLFOXIRI plus bevacizumab, FOLFOXIRI plus cetuximab |
| OxaliplatinOxaliplatin 85mg/m² day 1 | Drug | FOLFOXIRI plus bevacizumab, FOLFOXIRI plus cetuximab |
| 5-FU5-FU 3000 mg/m² iv over 48 h days 1-2 | Drug | FOLFOXIRI plus bevacizumab, FOLFOXIRI plus cetuximab |
| CetuximabCetuximab initially 400 mg/m² with infusion rate of ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8 | Drug | FOLFOXIRI plus cetuximab |
Primary outcome
Overall Response Rate (ORR)
Time frame: up to 48 months
(overall response rate) measured in percentage of all treated patients according to RECIST 1.1 criteria
7 secondary outcomes
Progression Free Survival (PFS)
Time frame: up to 60 months
Overall Survival (OS)
Time frame: up to 60 months
Investigation of Early Tumour Shrinkage (ETS) as early-on-Treatment predictor for treatment
Time frame: up to 48 months
Investigation of Depth of Response (DpR) to define nadir for tumour response.
Time frame: up to 48 months
Investigation of Molecular Biomarkers for Prediction of an Anti-EGFR Treatment
Time frame: up to 48 months
Prospective Analysis of Tumour Marker Level Evolution (CEA and CA 19-9)
Time frame: up to 48 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- 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.
Volker Heinemann, Prof. Dr. principal investigator
Medizinische Klinik III
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 Bevacizumab, Irinotecan and Folinic acid in people with Metastatic Colorectal Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 25 inclusion and 25 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 14 Nov 2023. 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 Germany. 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?
Overall Response Rate (ORR) (time frame: up to 48 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 14 Nov 2023.