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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Active Comparator | Standard dosing paclitaxel: 80 mg/m2 QW intravenously) |
|
| MM-121 (SAR256212) + Paclitaxel | Experimental | administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM-121 | Drug | MM-121 (SAR256212) (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD). | Time from first dose to date of progression, the longest time frame of 3.9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death. | Time from first dose to date of death, with a median of approximately 13 months |
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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 |
|---|---|---|---|---|---|---|
| Arizona Center for Cancer Care | Glendale | Arizona | 85306 | United States | ||
| Pinnacle Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27998236 | Derived | Liu JF, Ray-Coquard I, Selle F, Poveda AM, Cibula D, Hirte H, Hilpert F, Raspagliesi F, Gladieff L, Harter P, Siena S, Del Campo JM, Tabah-Fisch I, Pearlberg J, Moyo V, Riahi K, Nering R, Kubasek W, Adiwijaya B, Czibere A, Naumann RW, Coleman RL, Vergote I, MacBeath G, Pujade-Lauraine E. Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer. J Clin Oncol. 2016 Dec 20;34(36):4345-4353. doi: 10.1200/JCO.2016.67.1891. Epub 2016 Oct 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MM-121 + Paclitaxel | MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes |
| FG001 | Paclitaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel | Drug | Standard dosing Paclitaxel (IV) |
|
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | United States |
| Wilshire Oncology Medical Group | Corona | California | 92879 | United States |
| North County Oncology | Oceanside | California | 92056 | United States |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | United States |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Carolinas Medical Center/Blumenthal Cancer Center | Charlotte | North Carolina | 28203 | United States |
| ProMedica Health System, Inc. | Toledo | Ohio | 43606 | United States |
| Chattanooga GYN Oncology | Chattanooga | Tennessee | 37403 | United States |
Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MM-121 + Paclitaxel | MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes |
| BG001 | Paclitaxel | Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes |
| 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/Ethnicity, Customized | 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 | Progression Free Survival | To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD). | Posted | Median | 95% Confidence Interval | months | Time from first dose to date of progression, the longest time frame of 3.9 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death. | Posted | Median | 95% Confidence Interval | months | Time from first dose to date of death, with a median of approximately 13 months |
|
| ||||||||||||||||||||||||||||||
| Post-Hoc | To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Paclitaxel in Formalin Fixed (FFPE) Tumor Samples | Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to Paclitaxel can increase PFS in HRG-high patients. | Patients with available tissue for RNA-ISH analysis | Posted | Median | 95% Confidence Interval | months PFS | Time from first dose to date of progression, the longest time frame of 3.9 years |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MM-121 + Paclitaxel | MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes | 59 | 140 | 140 | 140 | ||
| EG001 | Paclitaxel | Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes | 25 | 80 | 79 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Colonic Fistula | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal Wall Hematoma | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hemorrhagic ascites | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Infusion Site Extravasion | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Escherichia Sepsis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pelvic Abscess | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Post-procedural Fistula | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| International Normalized Ratio Increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Mental Status Change | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Renal Pain | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary Fistula | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Toxic Skin eruption | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pelvic Venous Thrombosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Peripheral Edema | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Stomatits | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Peripheral neuropathy | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Parasthesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Influenza-like illness | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Palmer-Plantar Erythrodysasthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Merrimack Pharmaceuticals | 617-441-1000 | smathews@merrimack.com |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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 |
|
| Black or African American |
|
| Alaska Native or American Indian |
|
| Asian/Oriental |
|
| Native Hawaiian or Pacific Islander |
|
| Other |
|
| Data Not Reported |
|
|
| OG003 | HRG Low: MM-121 + Paclitaxel | MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes |
|
|
|