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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.
This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 plus cetuximab plus irinotecan. The study assessed the safety, tolerability, and pharmacokinetics of MM-121, cetuximab and irinotecan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: MM-121 + cetuximab | Experimental | increasing doses of weekly MM-121 + weekly cetuximab |
|
| Part 2: MM-121 + cetuximab + irinotecan | Experimental | increasing doses of irinotecan + the Recommended Phase 2 Dose/Maximum Tolerated Dose (RP2D/MTD) of MM121 + cetuximab as determined in Part 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM-121 | Drug | escalating doses MM-121 IV QW |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination | To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD. | From date of first dose to 30 days after termination, the longest 48.1 weeks |
| To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD Part 1: Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW Part 2: Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 | From date of first dose to 30 days after termination, the longest 48.1 weeks |
| To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD Part 1: Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW Part 2: Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR. | Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Moyo, MD | Merrimack Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | 94115 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Cohort 1 | MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses |
| FG001 | Part 1: Cohort 2a |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Irinotecan | Drug | 180 mg/m2 IV Q2W |
|
|
| Cetuximab | Drug | escalating doses cetuximab IV QW |
|
|
| From date of first dose to 30 days after termination, the longest 48.1 weeks |
| Pharmacokinetics | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2) | Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121 |
| Pharmacokinetic Parameters of MM-121 | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2) | Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121 |
| Immunogenicity | Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies). | Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Salt Lake City | Utah | 84112 | United States |
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
| FG002 | Part 1: Cohort 2b | MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW |
| FG003 | Part 1: Cohort 3a | MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW |
| FG004 | Part 1: Cohort 3b | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW |
| FG005 | Part 1: Cohort 4 | MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW |
| FG006 | Part 1: Expansion Cohort | MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW |
| FG007 | Part 2: Cohort 1 | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
| FG008 | Part 2: Cohort 2 | MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
| FG009 | Part 2: Expansion Cohort | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: MM-121 + Cetuximab | increasing doses of weekly MM-121 + weekly cetuximab MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) |
| BG001 | Part 2: MM-121 + Cetuximab + Irinotecan | increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) |
| 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination | To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD. | Patients participating in dose escalation | Posted | Number | participants reporting DLTs | From date of first dose to 30 days after termination, the longest 48.1 weeks |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD Part 1: Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW Part 2: Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 | Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs) MTD of cetuximab and irinotecan for the combination(s) are presented in a separate endpoint entry | Posted | Number | mg/kg | From date of first dose to 30 days after termination, the longest 48.1 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD Part 1: Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW Part 2: Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 | Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs and thus not included in determining MTD/RP2D) NOTE: MTD of MM-121 provided in separate endpoint entry | Posted | Number | mg/m2 | From date of first dose to 30 days after termination, the longest 48.1 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR. | Posted | Number | participants with objective response | Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2) | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters of MM-121 | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2) | Data presented by dose level of MM-121, regardless of the cohort (i.e. 15 patients in Part 1 were administered the 40/20 dose level of MM-121: 3 in cohort 3b, 4 in cohort 4, and 8 in the Part 1 expansion) | Posted | Geometric Mean | Geometric Coefficient of Variation | hr* ug/mL | Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity | Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies). | Posted | Number | Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction |
|
AEs were collected from a patient's first dose until 30 days after treatment termination. SAEs were collected from time of informed consent until 30 days after termination. If related, events could be reported at any time after termination.
All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for ~1 year after termination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: MM-121 + Cetuximab | increasing doses of weekly MM-121 + weekly cetuximab MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) | 15 | 34 | 34 | 34 | ||
| EG001 | Part 2: MM-121 + Cetuximab + Irinotecan | increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) | 6 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lyphoedema | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis Acneform | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Rash Maculopapular | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pruritis Generalized | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Nail Discoloration | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Mucosal Inflammation | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Chills | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Asthenia | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Impaired healing | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Oral Pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dygeusia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Ataxia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Peripheral Neuropathy | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Central Nervous System Lesion | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Neuralgia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Paronychia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Fungal Skin Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Bronchitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Nail Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Oral Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Tinea Cruris | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Vision Blurred | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Conjunctivitis | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Lacrimation increased | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Ocular Hyperaemia | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Weight Decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Blood Magnesium Decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| White Blood Cell Count Decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Neutrophil Count Decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Nasal Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Post-Procedural Swelling | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Depression | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Confusional State | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pericardial effusion | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Merrimack Pharmaceuticals, Inc. | 617-441-1000 | smathews@merrimack.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast 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 |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589319 | seribantumab |
| D000077146 | Irinotecan |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Part 2: MM-121 + Cetuximab + Irinotecan | increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) |
|
|
| OG001 | Part 2: MM-121 + Cetuximab + Irinotecan | increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) |
|
|
MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
| OG004 | Part 1: Cohort 3b | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW |
| OG005 | Part 1: Cohort 4 | MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW |
| OG006 | Part 1: Expansion Cohort | MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW |
| OG007 | Part 2: Cohort 1 | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
| OG008 | Part 2: Cohort 2 | MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
| OG009 | Part 2: Expansion Cohort | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
|
|
| OG003 | Part 2: 20 mg/kg | MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2 |
| OG004 | Part 2: 40/20 mg/kg | MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2 |
|
|
MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2 |
| OG003 | Part 2: 20 mg/kg | MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2 |
| OG004 | Part 2: 40/20 mg/kg | MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2 |
|
|
| OG004 | Part 1: Cohort 3b | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW |
| OG005 | Part 1: Cohort 4 | MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW |
| OG006 | Part 1: Expansion Cohort | MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW |
| OG007 | Part 2: Cohort 1 | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
| OG008 | Part 2: Cohort 2 | MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
| OG009 | Part 2: Expansion Cohort | MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W |
|
|