Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003727-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic colorectal cancer.
This Phase Ib/II study investigated the anti-tumor activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male participants affected by PIK3CA-mutated, neuroblastoma-Kristen-rat sarcoma virus (N-K-RAS) wild-type, and BRAF wild-type metastatic colorectal cancer.
MEN1611 is a potent, selective class I phosphoinositide 3-kinase (PI3K) inhibitor. The maximum tolerated dose of MEN1611 given as single agent was assessed in a Phase I trial in participants with advanced solid tumors.
This Phase Ib/II started with a dose confirmation part (Step 1) to identify the recommended phase 2 dose of MEN1611 given in combination with cetuximab.
The study continued with a cohort expansion (Step 2) to explore the anti-tumor activity of the selected MEN1611 dose level combined with cetuximab with further assessment of safety and tolerability.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEN1611 | Experimental | MEN1611 + Cetuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEN1611 | Drug | MEN1611 oral dose administered twice daily for a continuous 28-day cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Recommended Phase 2 Dose (RP2D) of MEN1611 in Combination With Cetuximab | RP2D was defined as the highest dose level in milligrams (mg) at which no more than 1 participant during the dose confirmation phase (Phase 1b) experienced a dose-limiting toxicity (DLT) during the DLT assessment window (28 days), or the maximum dose judged to be tolerable by the data safety committee. | Day 1 through Day 28 of Cycle 1 (28 days/cycle) |
| Best Overall Response Rate (ORR) of MEN1611 in Combination With Cetuximab | The best ORR was defined as percentage of participants who had a best overall response to therapy of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) and was defined according to Response Evaluation Criteria in Solid Tumors version 1.1 assessment locally performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands). | Up to 37 Months |
| Phase 1b: Number of Participants With DLTs for MEN1611 | A DLT was defined as any of the following adverse drug reactions (ADRs) related to the combination regimens or to MEN1611 alone and unrelated to the participants' underlying disease or concomitant medication occurring during Cycle 1 over the DLT assessment window of 28 days: any Grade 3 (lasting >7 days) or Grade 4 increase in aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase; any Grade ≥3 cardiac disorder or new segmental wall-motion abnormalities; any Grade ≥3 non-hematologic toxicity with the following exceptions: nausea, vomiting, diarrhea, skin rash, hyperglycemia. An ADR was defined as any adverse event suspected by the investigator and/or the sponsor to be related to MEN1611, cetuximab, or both given in combination. | Day 1 through Day 28 of Cycle 1 (28 days/cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of MEN1611 in Combination With Cetuximab | Blood samples were taken for the analyses of MEN1611 in plasma at designated time points. Results are reported as nanograms/millilitre (ng/mL). | Day 22 (1.5 hours postdose) of Cycle 1 (28 days/cycle) |
| Disease Control Rate (DCR) of MEN1611 in Combination With Cetuximab |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josep Tabernero, MD, PhD | Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| The Oncology Institute of Hope and Innovation |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b (Dose Confirmation) | Participants received MEN1611 twice daily and cetuximab weekly, every 28-day cycle. |
| FG001 | Phase 2 (Cohort Expansion) | Participants received MEN1611 twice daily and cetuximab weekly, every 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2023 | Feb 10, 2025 |
Not provided
Not provided
Step 1: Confirmation of Dose for Cohort Expansion / Step 2: Cohort Expansion
Not provided
Not provided
Not provided
Not provided
| Cetuximab |
| Drug |
Cetuximab solution for infusion administered weekly via intravenous infusion. |
|
DCR was defined as percentage of participants whose disease shrank or remained stable over a certain time period and was calculated based on the sum of the CR, PR, and SD rates according to local assessment. |
| Up to 37 Months |
| Duration of Response (DOR) of MEN1611 in Combination With Cetuximab | DOR was defined as the time from confirmation of a PR, CR or SD as locally assessed, until the disease had been shown to progress following treatment. Participants with a previous response who did not show a relapse or died without recording a relapse were censored at their last available relapse-free tumor assessment date. Participants with only one tumor assessment after baseline showing a PD were not included in the calculation. | Up to 37 months |
| Progression-free Survival (PFS) of MEN1611 in Combination With Cetuximab | PFS was defined as the number of days between the first study treatment administration to the date of first documented disease progression as per local assessment, relapse or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last tumor assessment date. | Up to 37 months |
| Overall Survival (OS) of MEN1611 in Combination With Cetuximab | OS was defined as the number of days between the first study treatment administration and death from any cause. Participants still alive that had withdrawn from the study were censored using the latest among end of study and follow-up dates. Drop-out participants were considered censored and the last available date in which the participant was known to be alive was considered. | Up to 37 months |
| Anaheim |
| California |
| 92801 |
| United States |
| MultiCare Health System Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| ICO - Site Paul Papin | Angers | 49055 | France |
| Centre Georges François Leclerc | Dijon | 21000 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44800 | France |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | 01307 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Klinikum der Universitaet Muenchen Campus Grosshadern | Munich | 81377 | Germany |
| Klinikum rechts der Isar der TU | Munich | 81675 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| Azienda Ospedaliero Universitaria San Martino | Genoa | 16132 | Italy |
| Istituto Europeo di Oncologia (IEO) | Milan | 20141 | Italy |
| Azienda Socio Sanitaria Territoriale Niguarda | Milan | 20162 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Amsterdam University Medical Center | Amsterdam | 1105 AZ | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Radboud Nijmegen | Nijmegen | 6525 GA | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 GD | Netherlands |
| Examen sp. z o.o. | Skórzewo | 60-185 | Poland |
| Centrum Onkologii-Instytut im.M.Sklodowskiej Curie | Warsaw | 00-001 | Poland |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Received At Least 1 Dose of Study Drug | Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: all participants who received at least 1 dose of MEN1611.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b (Dose Confirmation) | Participants received MEN1611 twice daily and cetuximab weekly, every 28-day cycle. |
| BG001 | Phase 2 (Cohort Expansion) | Participants received MEN1611 twice daily and cetuximab weekly, every 28-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1b: Recommended Phase 2 Dose (RP2D) of MEN1611 in Combination With Cetuximab | RP2D was defined as the highest dose level in milligrams (mg) at which no more than 1 participant during the dose confirmation phase (Phase 1b) experienced a dose-limiting toxicity (DLT) during the DLT assessment window (28 days), or the maximum dose judged to be tolerable by the data safety committee. | Safety Population: all participants who received at least 1 dose of MEN1611. As pre-specified, RP2D data were collected and are reported for 'Phase 1b (Dose Confirmation)' cohort only. | Posted | Number | mg | Day 1 through Day 28 of Cycle 1 (28 days/cycle) |
|
|
| ||||||||||||||||||||||||||
| Primary | Best Overall Response Rate (ORR) of MEN1611 in Combination With Cetuximab | The best ORR was defined as percentage of participants who had a best overall response to therapy of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) and was defined according to Response Evaluation Criteria in Solid Tumors version 1.1 assessment locally performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands). | Efficacy Population: all participants who received at least 2 complete treatment cycles and had at least 1 disease assessment. | Posted | Number | percentage of participants | Up to 37 Months |
|
| |||||||||||||||||||||||||||
| Primary | Phase 1b: Number of Participants With DLTs for MEN1611 | A DLT was defined as any of the following adverse drug reactions (ADRs) related to the combination regimens or to MEN1611 alone and unrelated to the participants' underlying disease or concomitant medication occurring during Cycle 1 over the DLT assessment window of 28 days: any Grade 3 (lasting >7 days) or Grade 4 increase in aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase; any Grade ≥3 cardiac disorder or new segmental wall-motion abnormalities; any Grade ≥3 non-hematologic toxicity with the following exceptions: nausea, vomiting, diarrhea, skin rash, hyperglycemia. An ADR was defined as any adverse event suspected by the investigator and/or the sponsor to be related to MEN1611, cetuximab, or both given in combination. | Dose-limiting Toxicity (DLT) Population: all participants who received at least 80% of MEN1611 and 75% of cetuximab during Cycle 1 with a safety follow-up of 28 days after the first administration of the study treatment. Any participant who experienced DLT was also considered evaluable, regardless of the dose received. As pre-specified, data were collected and reported for the 'Phase 1b (Dose Confirmation)' cohort only. | Posted | Count of Participants | Participants | Day 1 through Day 28 of Cycle 1 (28 days/cycle) |
| ||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of MEN1611 in Combination With Cetuximab | Blood samples were taken for the analyses of MEN1611 in plasma at designated time points. Results are reported as nanograms/millilitre (ng/mL). | Pharmacokinetics (PK) Set: all participants who received MEN1611 and for whom a PK sample was obtained and analyzed. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | Day 22 (1.5 hours postdose) of Cycle 1 (28 days/cycle) |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) of MEN1611 in Combination With Cetuximab | DCR was defined as percentage of participants whose disease shrank or remained stable over a certain time period and was calculated based on the sum of the CR, PR, and SD rates according to local assessment. | Efficacy Population: all participants who received at least 2 complete treatment cycles and had at least 1 disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 37 Months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) of MEN1611 in Combination With Cetuximab | DOR was defined as the time from confirmation of a PR, CR or SD as locally assessed, until the disease had been shown to progress following treatment. Participants with a previous response who did not show a relapse or died without recording a relapse were censored at their last available relapse-free tumor assessment date. Participants with only one tumor assessment after baseline showing a PD were not included in the calculation. | Efficacy Population: all participants who received at least 2 complete treatment cycles and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Up to 37 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) of MEN1611 in Combination With Cetuximab | PFS was defined as the number of days between the first study treatment administration to the date of first documented disease progression as per local assessment, relapse or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last tumor assessment date. | Efficacy Population: all participants who received at least 2 complete treatment cycles and had at least 1 disease assessment. | Posted | Median | 95% Confidence Interval | days | Up to 37 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) of MEN1611 in Combination With Cetuximab | OS was defined as the number of days between the first study treatment administration and death from any cause. Participants still alive that had withdrawn from the study were censored using the latest among end of study and follow-up dates. Drop-out participants were considered censored and the last available date in which the participant was known to be alive was considered. | Efficacy Population: all participants who received at least 2 complete treatment cycles and had at least 1 disease assessment. | Posted | Median | 95% Confidence Interval | days | Up to 37 months |
|
|
From Day 1 to the end of study (37 months)
All reported safety data based upon the Safety Population: all participants who received at least 1 dose of MEN1611.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b (Dose Confirmation) | Participants received MEN1611 twice daily and cetuximab weekly, every 28-day cycle. | 7 | 7 | 5 | 7 | 7 | 7 |
| EG001 | Phase 2 (Cohort Expansion) | Participants received MEN1611 twice daily and cetuximab weekly, every 28-day cycle. | 11 | 22 | 11 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Scrotal swelling | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment | This adverse event affected only male participants. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
The results of the study cannot be submitted for presentation, abstract, poster exhibition, or publication by the investigator until Menarini Ricerche S.p.A. has reviewed/commented and agreed to any publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Sciences | Menarini Ricerche S.p.A. | +39 0555680 | 9990 | martine.piccart@bordet.be |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2023 | Feb 10, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|