Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000565-76 | EudraCT Number |
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Merrimack Inc. terminated the trial early due to business decision
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This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.
This study is a randomized, double-blind, placebo-controlled international phase 2 trial in patients with HRG+, HR+, HER2- metastatic breast cancer that has progressed following treatment with no more than 2 prior therapies, one of which must have been a CDK inhibitor. All patients will be screened for heregulin using central testing, and eligible patients will be randomized to receive either seribantumab + fulvestrant or placebo + fulvestrant. Disease status will be assessed according to RECIST v 1.1 to support the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Seribantumab Fulvestrant |
|
| Arm B | Active Comparator | Placebo Fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seribantumab | Drug | Seribantumab is a human monoclonal antibody that inhibits ErbB3 signalling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v1.1 or death from any cause, whichever comes first as assessed by the investigator. The tumor assessment (i.e., scan dates) was used for progression/censor date not the date corresponding to the determination of overall response. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. | Randomization until progression of disease or death due to any cause up to 13 months (The study terminated prematurely) . The primary analysis was planned to be initiated when 58 PFS events have occurred |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause. The study was terminated on 30 Nov 2018 . Data represents outcomes up to 150 days of treatment. | Randomization until death due to any cause up to 13 months (The study terminated prematurely) |
Not provided
Inclusion Criteria:
To be eligible for participation in the study, patients must meet the following criteria. Patients who are HRG negative do not need to complete screening procedures beyond HRG assessment.
Exclusion Criteria:
Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria.
Confirmed postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1).
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| Name | Affiliation | Role |
|---|---|---|
| Marc Pipas, MD | Merrimack Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer and Research Centers- Chandler | Chandler | Arizona | 85224 | United States | ||
| Highland Oncology Group |
Not provided
At the time of the study termination by the prior Sponsor (Merrimack Pharmaceuticals), 62 sites participated in the study (27 in North America and 35 in Europe).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Experimental): Seribantumab and Fulvestrant | Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2017 | Apr 29, 2020 |
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Patients will be randomized in a 1:1 ratio (experimental arm versus active comparator arm) using an Interactive Web Response System (IWRS). Randomization will be stratified based on bone-only disease (yes, no) and geographic region (US, non-US).
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This is a multi-center, randomized, double-blind, placebo-controlled Phase 2 Study.
| Fulvestrant | Drug | Fulvestrant is an estrogen receptor antagonist with no agonist effects |
|
|
| Placebo | Drug | Placebo |
|
|
| Objective Response Rate |
Objective Response Rate (ORR) is defined as the proportion of patients with a RECIST v1.1 response recorded from randomization until disease progression characterized as either a Complete Response (CR) or Partial Response (PR) relative to the total number of evaluable patients. |
| Randomization through end of study up to 13 months (The study terminated prematurely) |
| Time to Progression | Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. | Randomization to date of objective tumor progression up to 13 months (The study terminated prematurely) |
| Number of Participants With Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone | Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration. | TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant |
| Percentage of Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone | Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration. | TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant |
| Pharmacokinetic (PK) Profile of Seribantumab When Given in Combination With Fulvestrant and of Fulvestrant When Given in Combination With Serbantumab. | Pharmacokinetic (PK) evaluation are performed on samples obtained pre-dose on day 1 and 15 of each 28-day cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 are measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). | The study terminated prematurely after 13 months. Were to be analyzed post-dose on Cycle 1,Week 1 & pre-dose for all subsequent seribantumab infusions until the completion of Cycle 2. Fulvestrant PK samples were to be collected prior to seribantumab dose |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90404-2131 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Saint Helena Hospital | St. Helena | California | 94574 | United States |
| Stamford Hospital | Stamford | Connecticut | 06902-3628 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Cancer Care Specialists of Central Illinois | Decatur | Illinois | 62526 | United States |
| James M Stockman Cancer Institute | Frederick | Maryland | 21701 | United States |
| Holy Cross Hospital Health Center | Silver Spring | Maryland | 20902 | United States |
| Lahey Clinical Medical Center | Burlington | Massachusetts | 01805 | United States |
| University of Mississippi | Jackson | Mississippi | 39216 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| Saint Francis Cancer Treatment Center | Grand Island | Nebraska | 68803 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Oncology Specialists of Charlotte | Charlotte | North Carolina | 28207 | United States |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Utah Health Care - Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| LKH - Universitätsklinikum Graz | Graz | 8036 | Austria |
| Universitaetsklinik fuer Gynaekologie und Geburtshilfe | Innsbruck | 6020 | Austria |
| Krankenhaus der Barmherzigen Schwestern Linz | Linz | 4010 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Clinique Saint-Pierre | Ottignies | Brabant Wallon | 1340 | Belgium |
| Centre Hospitalier de l'Ardenne - Clinique du Sein | Libramont | Luxembourg | 6800 | Belgium |
| Universitaire Ziekenhuis Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Antwerp | 2650 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| CHU UCL NAMUR - Sainte Elisabeth | Namur | 5000 | Belgium |
| University of Calgary | Calgary | Alberta | T2S 3C3 | Canada |
| British Columbia Cancer Agency | Kelowna | British Columbia | V1Y 5L3 | Canada |
| McGill University - Jewish General Hospital | Montreal | H3T 1E2 | Canada |
| Centre Hospitalier Affilie Universitaire de Quebec | Québec | G1S 4L8 | Canada |
| Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Medizinisches Zentrum Bonn Friedensplatz | Bonn | 53111 | Germany |
| Centrum fuer Haematologie und Onkologie Bethanien | Frankfurt | Germany |
| Gynäkologisch-Onkologische Praxis Hannover | Hanover | 30177 | Germany |
| Rotkreuzklinikum München-Frauenklinik | Munich | 80637 | Germany |
| Klinikum Rechts der Isar der Technischen Universität München | München | 81675 | Germany |
| Onkologie Rheinsieg | Troisdorf | 53840 | Germany |
| Universitätsklinikum Ulm | Ulm | 89075 | Germany |
| Hospital Universitari General de Catalunya | Sant Cugat del Vallès | Barcelona | 08190 | Spain |
| Complejo Hospitalario Universitario La Coruña | A Coruña | 15006 | Spain |
| Hospital Teresa Herrera | A Coruña | 15006 | Spain |
| Hospital Universitari de Girona Doctor Josep Trueta | Girona | 17007 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Ramón Y Cajal | Madrid | 28034 | Spain |
| Hospital ClÃnico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 07198 | Spain |
| De La Cruz Merino, Luis | Seville | 41009 | Spain |
| Hospital ClÃnico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 59009 | Spain |
| FG001 | Arm B (Control): Placebo and Fulvestrant | Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
| COMPLETED |
|
| NOT COMPLETED |
|
Patients that have signed informed consent, identified as HRG positive based on centralized tissue analysis,& have successfully completed study entry criteria (Safety Population- patients receiving at least one dose of study medication).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Experimental): Seribantumab and Fulvestrant | Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
| BG001 | Arm B (Control): Placebo and Fulvestrant | Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| 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 |
| ||||||||||||||||||
| Metastatic burden (TNM Stage at Initial Diagnosis) | Based upon the population treated, the most important baseline measure was CT scans to determine metastatic burden, as the primary endpoint was investigator assessed PFS. TNM Staging (Tumor size): T1 (T1a,T1b & T1c): 2 cm (3/4 of an inch) or less across. T2: > 2 cm but not more than 5 cm (2 inches) across. T3: > 5 cm across. T4 (T4a,T4b,T4c,T4d): Tumor of any size growing into the chest wall or skin. As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means cancer has spread more. And within a stage, an earlier letter means a lower stage. | Number | Participants |
| |||||||||||||||||
| Heregulin positive status and staining in archival tissue | Women had to be ≥ HRG 1+ positive in their submitted tumor sample to qualify for the study | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v1.1 or death from any cause, whichever comes first as assessed by the investigator. The tumor assessment (i.e., scan dates) was used for progression/censor date not the date corresponding to the determination of overall response. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. | Intent-to-Treat (ITT) population treated up to 150 days | Posted | Number | Participants | Randomization until progression of disease or death due to any cause up to 13 months (The study terminated prematurely) . The primary analysis was planned to be initiated when 58 PFS events have occurred |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause. The study was terminated on 30 Nov 2018 . Data represents outcomes up to 150 days of treatment. | Intent-to-Treat (ITT) population treated up to 150 days | Posted | Number | participants | Randomization until death due to any cause up to 13 months (The study terminated prematurely) |
| |||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective Response Rate (ORR) is defined as the proportion of patients with a RECIST v1.1 response recorded from randomization until disease progression characterized as either a Complete Response (CR) or Partial Response (PR) relative to the total number of evaluable patients. | Incomplete data for all subjects due to length of time on study treatment and frequency of scanning. All patients analysed had progressive disease. Therefore, they did not meet the criteria for ORR and hence could not be evaluated for CR or PR | Posted | Randomization through end of study up to 13 months (The study terminated prematurely) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Progression | Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. | Intent-to-Treat (ITT) population consisted of all participants randomized to the study. | Posted | Median | Inter-Quartile Range | days | Randomization to date of objective tumor progression up to 13 months (The study terminated prematurely) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone | Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration. | Safety Population: The safety population includes patients receiving at least one dose of study medication. All safety analyses were to be performed on this population. | Posted | Number | participants | TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Treatment-emergent Adverse Events Reported With the Combinations of Seribantumab Plus Fulvestrant Versus Fulvestrant Alone | Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration. | Safety Population: The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. | Posted | Number | percentage of adverse events | TEAEs were collected through the study completion (30 Nov 2018), up to 13 months. Frequency and percent summaries were presented for TEAE defined as adverse events that occur or worsen in severity following the first dose of seribantumab, or fulvestrant |
| |||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Profile of Seribantumab When Given in Combination With Fulvestrant and of Fulvestrant When Given in Combination With Serbantumab. | Pharmacokinetic (PK) evaluation are performed on samples obtained pre-dose on day 1 and 15 of each 28-day cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 are measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). | Due to the premature study termination, the PK data were not collected. There was no pharmacokinetic data feasible for the analysis, and as such, no related analyses were performed. Hence, data could not be reported in the data table. | Posted | The study terminated prematurely after 13 months. Were to be analyzed post-dose on Cycle 1,Week 1 & pre-dose for all subsequent seribantumab infusions until the completion of Cycle 2. Fulvestrant PK samples were to be collected prior to seribantumab dose |
|
From Baseline through to premature study completion up to 13 months (30 Nov 2018)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
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 | Arm A (Experimental): Seribantumab and Fulvestrant | Seribantumab (a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): fixed dose of 3000 mg intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle | 10 | 11 | 1 | 11 | 10 | 11 |
| EG001 | Arm B (Control): Placebo and Fulvestrant | Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle | 10 | 11 | 0 | 11 | 8 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Eye allergy | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Sponsor (Merrimack Pharmaceuticals, INC.) terminated the trial early due to business decision
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Operations | Elevation oncology | +1-716 371 1125 | clinical@elevationoncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2016 | Apr 29, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589319 | seribantumab |
| D000077267 | Fulvestrant |
| D006639 | Histidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| >=65 years |
|
| 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 |
|
| Belgium |
|
| United States |
|
| Spain |
|
| TNM Stage II |
|
| TNM Stage IIa |
|
| TNM Stage IIb |
|
| TNM Stage III |
|
| TNM Stage IIIa |
|
| TNM Stage IIIc |
|
| TNM Stage IV |
|
Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle
Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle
|
|
| OG001 |
| Arm B (Control): Placebo and Fulvestrant |
Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
|
|
|
| OG001 | Arm B (Control): Placebo and Fulvestrant | Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
|
|
| OG001 | Arm B (Control): Placebo and Fulvestrant | Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
|
|
| OG001 | Arm B (Control): Placebo and Fulvestrant | Placebo: intravenously (IV) on day 1 and 15 of each 28-day cycle Fulvestrant: (a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor): 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle |
|