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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies
This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 in combination with certain anticancer therapies. The dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 and/or the anticancer therapy were escalated until either the MTD is identified or the combination was shown to be tolerable at the highest planned doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM-121 plus Gemcitabine | Experimental | escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle |
|
| MM-121 plus Carboplatin | Experimental | carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle |
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| MM-121 plus Pemetrexed | Experimental | pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle |
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| MM-121 plus Cabazitaxel | Experimental | escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM-121 | Drug | MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies | Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting | From date of first dose to 30 days after termination, the longest 88.1 weeks |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3 | From date of first dose to 30 days after termination, the longest 88.1 weeks |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 |
| 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 response during their time on study, the longest of which was 88.1 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 |
|---|---|---|---|---|---|---|
| Lafayette | Indiana | 47905 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | MM-121 Plus Gemcitabine: Cohort 1 | MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle |
| FG001 | MM-121 Plus Gemcitabine: Cohort 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carboplatin | Drug | administered at AUC 6 |
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| Pemetrexed | Drug | administered IV at 500 mg/m2 |
|
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| Cabazitaxel | Drug | administered IV at 20 mg/m2 or 25 mg/m2 |
|
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| Gemcitabine | Drug | administered IV at 1000 mg/m2 or 1250 mg/m2 |
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| From date of first dose to 30 days after termination, the longest 88.1 weeks |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin | Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1 | From date of first dose to 30 days after termination, the longest 88.1 weeks |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1 | From date of first dose to 30 days after termination, the longest 88.1 weeks |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3 | From date of first dose to 30 days after termination, the longest 88.1 weeks |
| To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies | To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies 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 to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort. | From date of first dose to 30 days after termination, the longest 88.1 weeks |
| Pharmacokinetics | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle 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). | Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion |
| Pharmacokinetics (AUClast) | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle 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 at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion |
| 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 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction |
| Buffalo |
| New York |
| 14263 |
| United States |
| Cincinnati | Ohio | 45267 | United States |
| Philadelphia | Pennsylvania | 19111 | United States |
| Villejuif | France |
MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle |
| FG002 | MM-121 Plus Carboplatin: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 6 Day 1 of every 3 week cycle |
| FG003 | MM-121 Plus Carboplatin: Cohort 2 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| FG004 | MM-121 Plus Carboplatin: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| FG005 | MM-121 Plus Pemetrexed: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| FG006 | MM-121 Plus Pemetrexed: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| FG007 | MM-121 Plus Cabazitaxel: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| FG008 | MM-121 Plus Cabazitaxel: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| FG009 | MM-121 Plus Cabazitaxel: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MM-121 Plus Gemcitabine | escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV |
| BG001 | MM-121 Plus Carboplatin | carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Carboplatin: administered at AUC 6 |
| BG002 | MM-121 Plus Pemetrexed | pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Pemetrexed: administered IV at 500 mg/m2 |
| BG003 | MM-121 Plus Cabazitaxel | escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies | Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting | Posted | Number | participants reporting adverse events | From date of first dose to 30 days after termination, the longest 88.1 weeks |
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| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3 | Note: data provided below is for MM-121 doses only for the combination. Combination therapy MTDs are provided in separate endpoint measures. | Posted | Number | mg/kg | From date of first dose to 30 days after termination, the longest 88.1 weeks |
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| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 | NOTE: Maximum tolerated dose is for the combination of gemcitabine and MM-121. MTD of MM-121 is provided in separate endpoint. | Posted | Number | mg/m2 | From date of first dose to 30 days after termination, the longest 88.1 weeks |
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| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin | Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1 | Posted | Number | target AUC (mg*min/mL) | From date of first dose to 30 days after termination, the longest 88.1 weeks |
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| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1 | Posted | Number | mg/m2 | From date of first dose to 30 days after termination, the longest 88.1 weeks |
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| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel | Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3 | Posted | Number | mg/m2 | From date of first dose to 30 days after termination, the longest 88.1 weeks |
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| Primary | To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies | To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies 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 to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort. | Posted | Number | participants reporting DLTs | From date of first dose to 30 days after termination, the longest 88.1 weeks |
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| 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 response during their time on study, the longest of which was 88.1 weeks |
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| Secondary | Pharmacokinetics | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion |
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| Secondary | Pharmacokinetics (AUClast) | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | hr* ug/mL | Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion |
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| 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 88.1 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 | MM-121 Plus Gemcitabine | escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV | 9 | 11 | 11 | 11 | ||
| EG001 | MM-121 Plus Carboplatin | carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Carboplatin: administered at AUC 6 | 7 | 11 | 11 | 11 | ||
| EG002 | MM-121 Plus Pemetrexed | pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Pemetrexed: administered IV at 500 mg/m2 | 3 | 10 | 10 | 10 | ||
| EG003 | MM-121 Plus Cabazitaxel | escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2 | 2 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| THROMBOTIC MICROANGIOPATHY | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CELLULITIS | 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 |
|
| ABSCESS LIMB | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GROIN ABSCESS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
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| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
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| ERYSIPELAS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | 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 |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| OESOPHAGEAL RUPTURE | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| VOMITING | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ATAXIA | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOTENSION | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| EMBOLISM | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DISEASE PROGRESSION | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CENTRAL VENOUS CATHETER REMOVAL | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| VOMITING | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ABDOMINAL RIGIDITY | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| OESOPHAGEAL STENOSIS | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ASCITES | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BREATH ODOR | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| OESOPHAGEAL RUPTURE | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PAINFUL DEFAECATION | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CHAPPED LIPS | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CELLULITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ORAL FUNGAL INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PNEUMONIA | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| EAR INFECTION | 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 |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RASH PUSTULAR | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RHINITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SINUSITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| TINEA PEDIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ABSCESS LIMB | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BRONCHITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GROIN ABSCESS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LOBAR PNEUMONIA | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ERYSIPELAS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| FUNGAL INFECTION | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PARONYCHIA | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| FOLLICULITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| OTITIS MEDIA | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| URETERITIS | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| FATIGUE | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PYREXIA | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ASTHENIA | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CHILLS | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| OEDEMA | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PAIN | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SUPRAPUBIC PAIN | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| XEROSIS | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CATHETER SITE RASH | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DISEASE PROGRESSION | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CHEST PAIN | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| INJECTION SITE HAEMORRHAGE | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| EARLY SATIETY | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GAIT DISTURBANCE | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| INJECTION SITE PAIN | General disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ANAEMIA | 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 |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| THROMBOTIC MICROANGIOPATHY | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SPLENOMEGALY | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOPHOSPHATAEMIA | 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 |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GOUT | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOGLYCEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPERNATRAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| POLYDIPSIA | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DYSPNOEA | 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 |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | 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 |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| NASAL DRYNESS | 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 |
|
| PLEURAL EFFUSION | 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 |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DYSPNOAE EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOXIA | 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 |
|
| NOCTURNAL DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ALOPECIA | 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 |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DERMATITIS | 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 |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SKIN HYPERPIGMENTATION | 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 |
|
| TELANGIECTASIA | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SKIN INDURATION | 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 |
|
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DERMATITIS ACNEFORM | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| NAIL RIDGING | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ONYCHOMADESIS | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ONYCHOCLASIS | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DIZZINESS | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| AGEUSIA | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ATAXIA | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CONVULSION | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HEADACHE | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| NEUROLOGICAL SYMPTOM | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PARAESTHESIA | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| TREMOR | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DYSGEUSIA | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SOMNOLENCE | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SYNCOPE | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PROTEINURIA | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DYSURIA | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BLADDER PAIN | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RENAL INJURY | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CYSTITIS NONINFECTIVE | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LEUKOCYTURIA | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| POLYURIA | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| WEIGHT DECREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| URINE OUTPUT DECREASED | Investigations | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| COSTOCHONDRITIS | 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 |
|
| MUSCULOSKELETAL CHEST 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 |
|
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BACK PAIN | 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 |
|
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CYTOLYTIC HEPATITIS | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HEPATOBILIARY DISEASE | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPERTRANSAMINASAEMIA | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| WOUND HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| EXCORIATION | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SNAKE BITE | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| INSOMNIA | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DEPRESSION | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PALPITATIONS | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| TACHYCARDIA | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SCROTAL DISORDER | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| PENIS DISORDER | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HAEMORRHAGE | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOTENSION | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| EMBOLISM | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| FLUSHING | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HAEMATOMA | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPERTENSION | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| DRY EYE | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BLEPHAROSPASM | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| BLINDNESS UNILATERAL | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CATARACT | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| EYE INFLAMMATION | Eye disorders | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| SINUS OPERATION | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment | Any Relationship |
|
| CENTRAL VENOUS CATHETER REMOVAL | Surgical and medical procedures | 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 |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000589319 | seribantumab |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| C552428 | cabazitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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 |
|
| France |
|
| OG001 | MM-121 Plus Carboplatin | carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Carboplatin: administered at AUC 6 |
| OG002 | MM-121 Plus Pemetrexed | pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Pemetrexed: administered IV at 500 mg/m2 |
| OG003 | MM-121 Plus Cabazitaxel | escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2 |
|
|
|
|
|
|
| OG003 | MM-121 Plus Carboplatin: Cohort 2 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| OG004 | MM-121 Plus Carboplatin: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| OG005 | MM-121 Plus Pemetrexed: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| OG006 | MM-121 Plus Pemetrexed: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| OG007 | MM-121 Plus Cabazitaxel: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| OG008 | MM-121 Plus Cabazitaxel: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| OG009 | MM-121 Plus Cabazitaxel: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle |
|
|
| OG003 | MM-121 Plus Carboplatin: Cohort 2 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| OG004 | MM-121 Plus Carboplatin: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| OG005 | MM-121 Plus Pemetrexed: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| OG006 | MM-121 Plus Pemetrexed: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| OG007 | MM-121 Plus Cabazitaxel: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| OG008 | MM-121 Plus Cabazitaxel: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| OG009 | MM-121 Plus Cabazitaxel: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle |
|
|
| OG003 | MM-121 + Cisplatin: 20/12 mg/kg | MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2 |
| OG004 | MM-121 + Gemcitabine: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m² |
| OG005 | MM-121 + Carboplatin: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6 |
| OG006 | MM-121 + Pemetrexed: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m² |
| OG007 | MM-121 + Cisplatin: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2 |
|
|
| OG003 | MM-121 + Cisplatin: 20/12 mg/kg | MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2 |
| OG004 | MM-121 + Gemcitabine: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m² |
| OG005 | MM-121 + Carboplatin: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6 |
| OG006 | MM-121 + Pemetrexed: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m² |
| OG007 | MM-121 + Cisplatin: 40/20 mg/kg | MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2 |
|
|
MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| OG004 | MM-121 Plus Carboplatin: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle Carboplatin at AUC 5 Day 1 of every 3 week cycle |
| OG005 | MM-121 Plus Pemetrexed: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| OG006 | MM-121 Plus Pemetrexed: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle |
| OG007 | MM-121 Plus Cabazitaxel: Cohort 1 | MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| OG008 | MM-121 Plus Cabazitaxel: Cohort 2 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle |
| OG009 | MM-121 Plus Cabazitaxel: Cohort 3 | MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle |
|
|