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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.
Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 1 dose was identified. Once the maximum tolerated dose was identified, an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM-121 + Paclitaxel | Experimental | Escalating doses of MM-121 given IV QW in combination with paclitaxel at standard dose of 80 mg/m2 IV QW |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM-121 | Drug | increasing doses of MM-121 IV QW |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | To establish the safety of escalating doses of MM-121 in combination with paclitaxel 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 163 weeks |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest | From date of first dose to 30 days after termination, the longest 163 weeks |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest |
| Measure | Description | Time Frame |
|---|---|---|
| To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akos Czibere, MD, PhD | Merrimack Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Dose Escalation: Cohort 1 | MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV |
| FG001 | Part 1: Dose Escalation: Cohort 2 | MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel | Drug | Paclitaxel - 80 mg/m2 IV QW |
|
|
| From date of first dose to 30 days after termination, the longest 163 weeks |
| patients were assessed for response during their time on study, the longest of which was 163 weeks |
| To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel | 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 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week). | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 |
| Pharmacokinetic Parameters (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 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 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week). Immunogenicity data is not available. | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 |
| 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 163 weeks, and a collection was made post-infusion in any case of infusion reaction |
| Pinnacle Oncology Hematology |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | United States |
| Cancer Care Associates of Fresno | Fresno | California | 93720 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| FG002 | Part 2: Expansion Cohort 1 | MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV |
| FG003 | Part 2: Expansion Cohort 2 | MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV |
| FG004 | Part 2: Cohort 3 | MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV |
| FG005 | Part 2: Cohort 4 | MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MM-121 + Paclitaxel: Dose Escalation | MM-121 plus Paclitaxel: Cohort 1: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV Cohort 2: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV Intermediate doses between cohorts 1 and 2 may also be considered. |
| BG001 | MM-121 + Paclitaxel: Expansion Cohort | MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly 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 Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | To establish the safety of escalating doses of MM-121 in combination with paclitaxel 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. | Posted | Number | participants reporting DLTs | From date of first dose to 30 days after termination, the longest 163 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest | NOTE: MTD of paclitaxel when administered with MM-121 provided in separate endpoint entry | Posted | Number | mg/kg | From date of first dose to 30 days after termination, the longest 163 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest | note: MTD of MM-121 when administered in combination with paclitaxel provided in separate endpoint entry | Posted | Number | mg/m2 | From date of first dose to 30 days after termination, the longest 163 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using 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 163 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel | 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 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week). | All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined. NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters (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 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 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week). Immunogenicity data is not available. | All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined. NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr* ug/mL | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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 163 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 + Paclitaxel: Dose Escalation | Cohort 1: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV Cohort 2: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV | 4 | 10 | 10 | 10 | ||
| EG001 | MM-121 + Paclitaxel: Expansion Cohort | Cohort 1: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV Cohort 2: MM-121 20 mg/kg IV loading dose x followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV Cohort 3: MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest | 12 | 31 | 31 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PEPTIC ULCER | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DEATH | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DISEASE PROGRESSION | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| FATIGUE | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ONYCHOMADESIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HEPATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SEPSIS | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| THROMBOSIS | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| MELAENA | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ORAL DISORDER | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ASCITES | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| FATIGUE | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CHEST DISCOMFORT | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CHILLS | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PAIN | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CATHETER SITE PAIN | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DEATH | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DISEASE PROGRESSION | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| EARLY SATIETY | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| FACIAL PAIN | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| OEDEMA | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PYREXIA | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ASTHENIA | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CHEST PAIN | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| FACE OEDEMA | General disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HORDEOLUM | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SINUSITIS | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| FUNGAL INFECTION | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NAIL INFECTION | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ONYCHOMYCOSIS | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PARONYCHIA | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PNEUMONIA | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| URINARY TRACT INFECTION PSEUDOMONAL | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VAGINAL INFECTION | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CELLULITIS | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| INFECTION | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPERKERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ONYCHALGIA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ONYCHOMADESIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PETECHIAE | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| INGROWING NAIL | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HEMICEPHALALGIA | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VISUAL FIELD DEFECT | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DYSARTHRIA | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SCIATICA | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| RHINORROEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPERGLYCEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| BACTERIAL TEST | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HAEMATOCRIT DECREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HEART RATE INCREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| SKIN TURGOR DECREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| WEIGHT DECREASED | Investigations | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ANXIETY | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DEPRESSION | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| DYSURIA | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| NOCTURIA | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| URETHRITIS NONINFECTIVE | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| URINARY TRACT PAIN | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| EAR DISORDER | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CONJUNCTIVAL IRRITATION | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| EYE PRURITUS | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| OCULAR HYPERAEMIA | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VAGINAL DISCHARGE | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VULVOVAGINAL DISCOMFORT | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| HOT FLUSH | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA 13.1 | Non-systematic Assessment | Any Relationship |
|
| VISION BLURRED | Eye disorders | MedDRA 13.1 | 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 |
|---|---|
| D009362 | Neoplasm Metastasis |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589319 | seribantumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV |
| OG004 | Part 2: Cohort 3 | MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV |
| OG005 | Part 2: Cohort 4 | MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest |
|
|
| OG002 | MM-121 + Paclitaxel: 40 mg/kg Q2W | MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2 |
| OG003 | MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week | MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit. Paclitaxel: 80 mg/m2 |
|
|
| OG002 | MM-121 + Paclitaxel: 40 mg/kg Q2W | MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2 |
| OG003 | MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week | MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit. Paclitaxel: 80 mg/m2 |
|
|
| OG004 |
| Part 2: Cohort 3 |
MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV |
| OG005 | Part 2: Cohort 4 | MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest |
|
|