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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003600-12 | EudraCT Number | ||
| 2023-506868-14 | Other Identifier | EU Trial Number |
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The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A [OC and EC participants] and Part B [OC only]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Part: Farletuzumab ecteribulin | Experimental | Participants with selected tumor types will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle. |
|
| Dose Confirmation Part: Farletuzumab ecteribulin | Experimental | Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle. |
|
| Dose Optimization Part A, Cohort 1: Farletuzumab ecteribulin + Oral Corticosteroids | Experimental | Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion and oral corticosteroids in a 21-day cycle. |
|
| Dose Optimization Part A, Cohort 2: Farletuzumab ecteribulin | Experimental | Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on three different days in a 21-day cycle. |
|
| Dose Optimization Part A, Cohort 3: Farletuzumab ecteribulin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Farletuzumab ecteribulin | Drug | Farletuzumab ecteribulin intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin | Cycle 1 (Cycle length is equal to [=] 21 days) | |
| Dose Optimization Part B: Recommended Dose (RD) of Farletuzumab Ecteribulin Monotherapy and in Combination With Lenvatinib | Up to approximately 5 years | |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the investigator assessment of radiologic response according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. | From date of first dose of study drug until first documentation of CR or PR (up to approximately 24 weeks) |
| Number of Participants With Dose-limiting Toxicities (DLTs) | DLTs are any of the toxicities occurring during Cycle 1 and assessed by the investigator as related to study drug. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0). | Cycle 1 (Cycle length=21 days) |
| Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Treatment Discontinuation and Adverse Events of Interest (AEIs) | AE: as any untoward medical occurrence in a participant administered with an investigational product. SAE: as any untoward medical occurrence that at any dose; resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted incongenital anomaly/birth defect. AEIs are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions. Number of participants with AEIs were reported based on safety assessment of participants with interstitial lung disease (ILD), severity of ILD, time to resolution and onset of ILD symptoms and deaths due to ILD. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the time from the first date of documented CR or PR to the date of disease progression or death, whichever occurs first. It will be calculated for participants whose BOR is CR or PR. DOR will be assessed according to RECIST version 1.1. | From first documented CR or PR until first documentation of recurrent or progressive disease or death (up to approximately 5 years) |
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Inclusion Criteria:
Aged >=18 years
For Dose-Escalation: Females (TNBC, EC and OC) or males/females (NSCLC, adenocarcinoma). Participants with the following disease characteristics:
Participants with the following tumor types, each as a separate arm:
Participants must have:
For Dose-Confirmation and Dose Optimization:
Note: Only participants with histologically confirmed diagnosis of advanced, recurrent, or metastatic EC will be enrolled at sites in France.
High-grade serous ovarian cancer or primary peritoneal cancer or fallopian tube cancer:
Platinum-resistant disease:
Have received up to 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to one line of therapy subsequent to determination of platinum-resistance. In Dose Optimization Part B participants may have received up to 3 prior lines of systemic therapy, up to 4 prior lines is permitted for participants who have received prior mirvetuximab soravtansine
Endometrial cancer (not enrolled in Dose Optimization Part B):
Available tumor tissue for FRA expression percent (%) by IHC analysis as assessed at a central laboratory. There is no minimum requirement for FRA expression (%). However, the tumor sample must be evaluable for IHC analysis (that is, of sufficient quality with adequate tumor content). Sample resubmission will be permitted for participants with tissue result of "non-evaluable" who are otherwise eligible. Tumor sample submission must be archival formalinfixed, paraffin-embedded (FFPE) tissue block, or unstained slides sectioned within 45 days from the latest FFPE block, or a fresh biopsy sample obtained during screening but prior to initiation of study treatment. Participants who have received prior treatment with mirvetuximab soravtansine will be required to provide a fresh biopsy sample during screening.
Radiological disease progression on or after the most recent therapy by investigator assessment.
Measurable disease meeting the following criteria (confirmed by central radiographic review, in the Dose-Confirmation Part only):
ECOG PS of 0 or 1.
Participants who are expected to survive a minimum of 3 months after the first administration of the study drug.
Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 milligram per deciliter (mg/dL) or calculated creatinine clearance >=50 milliliter per (mL) /minute according to a 12 or 24 hour urine collection.
For Dose Optimization Part B, adequate renal function as evidenced by calculated creatinine clearance >=50 milliliters per minute (mL/min) by Cockcroft-Gault formula.
Adequate bone marrow function, as evidenced by:
Adequate liver function, as evidenced by:
Participants must undergo a washout period required from the end of prior treatment to the first administration of the study drug that will be as follows:
Prior anticancer therapy:
Participants with a history of deep vein thrombosis (DVT) within 3 months of enrollment must be on a stable dose of anticoagulation as demonstrated by appropriate laboratory parameters (depending on the anticoagulant agent) for a minimum of 2 weeks before to starting study treatment. Anticoagulation must continue while on study treatment.
Participants at risk for DVT secondary to central venous catheters or with past medical history of DVT or clinical symptoms suggestive of DVT must have venous Doppler ultrasonography to rule out DVT during the screening period and before to initiation of study treatment.
If a participant has undergone major surgery, the participant must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Resolution of anticancer therapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (Grade <=2), anemia ([haemoglobin] Hgb >=9.0 g/dL), and alopecia (any grade).
Participant must be willing and able to comply with all aspects of the protocol.
Participant must provide written informed consent prior to any study-specific screening procedures.
For cohorts where MORAb-202 is used in combination with lenvatinib: Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP <=150/90 millimeter of mercury (mm Hg) and no change in antihypertensive medications within 1 week before the first administration of the study drug.
Exclusion Criteria:
Participants with endometrial leiomyosarcoma, endometrial stromal sarcoma or other soft tissue sarcoma histology.
Participants who received previous treatment with any folate receptor targeting agents, except for mirvetuximab soravtansine in the setting of FRA >=75%.
Participants with platinum refractory ovarian cancer (defined as disease progression during the initial platinum-based chemotherapy treatment).
Currently enrolled in another clinical study or used any investigational drug or device, which in the opinion of the Sponsor may interfere with the study treatment, within the past 28 days or 5 times the half-life (where prior drug therapy falls under the parameters these Inclusion Criteria should be followed) of any investigational drug preceding informed consent.
Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 2 weeks before starting treatment in this study. Brain metastases must be stable for at least 4 weeks on 2 consecutive scans of the brain before starting study treatment.
Diagnosed with meningeal carcinomatosis.
Any other invasive malignancy that required treatment (other than definitive surgery) or has shown evidence of recurrence/progression (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 2 years prior to starting study treatment.
Significant cardiovascular impairment. History within 6 months prior to the first dose of study drug of: congestive heart failure greater than New York Heart Association (NYHA) Class II); unstable angina; myocardial infarction; stroke; cardiac arrhythmia associated with hemodynamic instability.
In addition, for participants enrolled in the MORAb-202 plus lenvatinib cohorts, significant cardiovascular impairment also includes: History of arterial thromboembolism within 12 months of starting study treatment; Left ventricular ejection fraction (LVEF) <50% or below the institutional normal range determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).Note: Medically controlled arrhythmia is permitted.
Clinically significant ECG abnormality, including marked prolonged baseline QT as corrected using Fridericia's formula (QTcF) (repeated demonstration of a QTcF interval >500 milliseconds [ms]). A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTcF.
For participants enrolled in the MORAb-202 plus lenvatinib cohorts, prolongation of the QTcF interval to >480 ms.
Known to be Human Immunodeficiency Virus (HIV) positive. Testing at entry not required.
Active viral hepatitis (B or C as demonstrated by positive serology). Testing at entry if there are no symptoms or history is not required unless as per local requirements.
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [Ć-hCG] or human chorionic gonadotropin [hCG]) with a minimum sensitivity of 25 International units per liter (IU/L) or equivalent units of Ć-hCG [or hCG]. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first administration of the study drug.
Females of childbearing potential who
within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 7 months (5*half-life plus 180 days) after study drug discontinuation.
For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
*Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
For Dose-Escalation only: Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 7 months (5*half-life plus 180 days) after study drug discontinuation). If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 4 months (5*half-life plus 90 days) after study drug discontinuation. No sperm donation is allowed during the study period and for 4 months (5*half-life plus 90 days) after study drug discontinuation.
Pulmonary Function Test (PFT) abnormalities: FEV1/FVC <0.7, FEV1 or FVC <80%, DLCO <80% or less than the lower limit of normal according to local institutional standards.
Current ILD/pneumonitis, or ILD/pneumonitis is suspected at Screening or history of interstitial lung disease (ILD)/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy.
Current infectious pneumonia, history of viral pneumonia (including COVID-19-related infection) with evidence of persistent radiologic abnormalities.
Lung-specific clinically significant illnesses including, but not limited to any underlying pulmonary disorder (example, pulmonary embolism), asthma, chronic obstructive pulmonary disease (COPD), and restrictive lung disease, or currently receiving any medication that is associated with a clinically significant risk of developing ILD.
Clinically significant pleural or pericardial effusion requiring drainage or ascites requiring peritoneal shunt.
Prior pneumonectomy.
History of chest radiotherapy. Participants with history of chest wall radiation (example, history of breast cancer) may be permitted if chest wall radiation is documented > 2 years before starting study treatment.
Any autoimmune, connective tissue, or inflammatory disorders (example, rheumatoid arthritis, Sjƶgren's syndrome, sarcoidosis, etc) where there is documented (or suspicion of) pulmonary involvement.
A known history of active TB (bacillus tuberculosis).
Scheduled for surgery during the study, other than minor surgery which would not delay study treatment.
An active clinically significant (in the opinion of the Investigator) infection requiring systemic therapy within 2 weeks prior to the first dose of study drug.
Administration of a live, attenuated vaccine within 4 weeks prior to the first dose of study drug, or anticipation that such a live attenuated vaccine will be required during the study. Inactivated vaccines (such as hepatitis A or polio vaccines) are permitted during the study. Seasonal influenza and COVID-19 vaccines that do not contain live virus are permitted.
Any prior hypersensitivity to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).
Known intolerance to either of the components of the study drug.
Any medical or other condition which, in the opinion of the investigator would preclude the participants participation in the clinical study.
Receiving any medication prohibited in combination with the study treatment(s) as described in the product label for eribulin, unless medication was stopped within 7 days prior to enrollment.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Dose Optimization Part B participants who receiving MORAb-202 in combination with lenvatinib:
>1+ proteinuria on dipstick, 24-hour urine protein is >=1 gram.
Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
Unable to take oral medication.
Major surgery within 3 weeks before the first dose of study treatment. Note: adequate wound healing after major surgery must be assessed clinically and independent of time elapsed for eligibility.
Serious nonhealing wound, ulcer or bone fracture.
Pre-existing Grade >=3 gastrointestinal (GI) or non-GI fistula.
Radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion / infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Contact | 1-888-274-2378 | esi_oncmedinfo@eisai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACRC/Arizona Clinical Research Center, Inc | Withdrawn | Tucson | Arizona | 85715 | United States | |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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The Part A of Dose Optimization is randomized, whereas the Dose Escalation, Dose Confirmation and Part B of Dose Optimization are non-randomized.
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Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on two different days in a 21-day cycle. |
|
| Dose Optimization Part B: Farletuzumab ecteribulin + Lenvatinib | Experimental | Participants with OC will either receive farletuzumab ecteribulin (MORAb-202) monotherapy as an intravenous infusion or in combination with lenvatinib, orally in a 21-day cycle. |
|
|
| Prednisone | Drug | Prednisone administered orally. |
|
| Prednisolone | Drug | Prednisolone administered orally. |
|
| Dexamethasone | Drug | Dexamethasone administered orally. |
|
| Lenvatinib | Drug | Lenvatinib administered orally. |
|
| Baseline up to 28 days after the last dose of study drug (up to approximately 5 years) |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD). DCR will be assessed according to RECIST version 1.1. | From first dose of study drug until first documentation of CR or PR or SD (up to approximately 5 years) |
| Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with BOR of CR, PR, or durable SD (duration of SD greater than or equal to [>=] 5 weeks). Duration of SD is defined as the time from the date of first dose to the date of the first documentation of disease progression or death, whichever occurs first. It will be calculated for participants whose BOR is SD. CBR will be assessed according to RECIST version 1.1. | From first dose of study drug until disease progression or death, whichever occurs first (up to approximately 5 years) |
| Progression Free Survival (PFS) | PFS is defined as the time from the date of first dose to the date of the first documentation of disease progression or death, whichever occurs first. PFS will be assessed according to RECIST version 1.1. | From first dose of study drug until disease progression, death, whichever occurs first (up to approximately 5 years) |
| Overall Survival (OS) | OS is defined as the time from the date of first dose to the date of death. For the participants who are alive or lost to follow up, OS is censored as the date of last known alive date or the date of data cutoff, whichever comes first. OS will be calculated using the Kaplan-Meier method. | From first dose of study drug until death (up to approximately 5 years) |
| Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values, Vital Signs, Body Weight and 12-lead Electrocardiograms | Baseline up to 28 days after the last dose of study drug (up to approximately 5 years) |
| Change From Baseline in Oxygen Saturation (SpO2) | Change from baseline in percent of SpO2 (measured by pulse oximetry) will be calculated by measuring oxygen saturation at rest and immediately after exercise. | Baseline up to 28 days after the last dose of study drug (up to approximately 5 years) |
| Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) | ECOG PS is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. ECOG has 6 levels (0 to 5). 0=Fully Active (Most Favorable Activity); 1=Restricted activity but ambulatory; 2=Ambulatory but unable to carry out work activities; 3=Limited Self-Care; 4=Completely Disabled, No self-care (Least Favorable Activity); 5=Dead. | Baseline, up to approximately 5 years) |
| Pharmacokinetics (PK) Profiles: Maximum Observed Serum Concentration (Cmax) for Farletuzumab Ecteribulin | Up to approximately 5 years |
| PK Profiles: Time of Cmax (tmax) for Farletuzumab Ecteribulin | Up to approximately 5 years |
| PK Profiles: Area Under the Serum Concentration-time Curve From 0 to Infinity (AUC[0-ā]) for Farletuzumab Ecteribulin | Up to approximately 5 years |
| PK Profiles: Terminal Elimination Phase Half-life (t½) for Farletuzumab Ecteribulin | Up to approximately 5 years |
| Total Antibody Concentration for Eribulin and Farletuzumab Ecteribulin | Up to approximately 5 years |
| Investigate tumor Folate Receptor Alpha (FRA) expression levels association with and predictive power for clinical outcomes (objective response and progression free survival) | Evaluate how clinical outcomes like objective response and progression free survival correlate with the level of expression of FRA in tumors. | Baseline up to 28 days after the last dose of study drug (up to approximately 5 years) |
| Universty of Arkansas for Medical Sciences |
| Completed |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Stanford Women's Cancer Center | Recruiting | Palo Alto | California | 94304 | United States |
| University of Miami | Completed | Coral Gables | Florida | 33146 | United States |
| Moffitt Cancer Center and Research Institute | Recruiting | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute | Completed | Atlanta | Georgia | 30322 | United States |
| Georgia Cancer Center | Recruiting | Augusta | Georgia | 30912 | United States |
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
| Ascension Illinois-Skokie Infustion Center | Withdrawn | Skokie | Illinois | 60077 | United States |
| Norton Healthcare | Withdrawn | Louisville | Kentucky | 40202 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | Baltimore | Maryland | 21287 | United States |
| Karmanos Cancer Institute | Completed | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Withdrawn | Detroit | Michigan | 48202 | United States |
| MD Anderson Cancer Center at Cooper | Completed | Camden | New Jersey | 08103 | United States |
| Columbia University Medical Center | Completed | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| University of Cincinnati Medical Center | Completed | Cincinnati | Ohio | 45219 | United States |
| OSU Wxner Medical Center | Withdrawn | Hilliard | Ohio | 43026 | United States |
| Oregon Health & Science University | Withdrawn | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Withdrawn | Charleston | South Carolina | 29425 | United States |
| Chattanooga's Program in Women's Oncology | Completed | Chattanooga | Tennessee | 37403 | United States |
| Vanderbilt University Medical Center | Withdrawn | Nashville | Tennessee | 07677 | United States |
| The University of Texas MD Anderson Cancer Center | Withdrawn | Houston | Texas | 77030 | United States |
| University of Virginia Comprehensive Cancer Center | Completed | Charlottesville | Virginia | 22903 | United States |
| Centre Antoine Lacassagne Centre RƩgional de Lutte Contre Le Cancer | Completed | Nice | Alpes-Maritimes | 06100 | France |
| ICANS - Institut de cancƩrologie Strasbourg Europe | Completed | Strasbourg | Bas-Rhin | 67200 | France |
| Institut Paoli Calmettes | Completed | Marseille | Bouches-du-Rhone | 13009 | France |
| Hopitaux de La Timone | Completed | Marseille | Bouches-du-Rhone | 13385 | France |
| Centre FranƧois Baclesse | Completed | Caen | Calvados | 1400 | France |
| Clinique Armoricaine de Radiologie-PPDS | Withdrawn | Saint-Brieuc | Cote-d'Amore | 22000 | France |
| EDOG Institut de Cancerologie de l'Ouest | Completed | Nantes | Loir-Atlantique | 44000 | France |
| Clinique Catherine de Sienne | Withdrawn | Nantes | Loir-Atlantique | 44200 | France |
| Centre Oscar Lambret | Completed | Lille | Nord | 59000 | France |
| Centre Hospitalier de La CƓte Basque | Completed | Bayonne | Pyrenees-Atlantiques | 64109 | France |
| Centre LƩon BƩrard Centre RƩgional de Lutte Contre Le Cancer RhƓne Alpes | Completed | Lyon | Rhone | 69008 | France |
| CLCC-Gustave Roussy Cancer | Completed | Vilejuif | Val-de-Marne | 94805 | France |
| HƓpital de la Croix Saint-Simon | Completed | Paris | 75020 | France |
| Hopital Cochin | Completed | Paris | 75679 | France |
| National Cancer Center Hospital | Recruiting | Chuo-ku | Tokyo | 1040045 | Japan |
| Cancer Institute Hospital of JFCR | Recruiting | Koto-ku | Tokyo | 1358550 | Japan |
| ICO Badalona-H.U. Germans Trias i Pujol | Recruiting | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio MaraƱon | Completed | Madrid | 28007 | Spain |
| Clinica Universidad de Navarra | Completed | Madrid | 28027 | Spain |
| Hospital Clinico San Carlos | Completed | Madrid | 28040 | Spain |
| Hospital Universitario Ramon y Cajal | Completed | Madrid | 28304 | Spain |
| Hospital Universitario de Toledo | Completed | Toledo | 45007 | Spain |
| Fundacion Instituto Valenciano de Oncologia | Completed | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Completed | Valencia | 46013 | Spain |
| Belfast City Hospital | Withdrawn | Belfast | Antrim | BT9 7AB | United Kingdom |
| Beatson West of Scotland Cancer Centre-PPDS | Completed | Glasgow | Glasgow City | G12 0YN | United Kingdom |
| The Christie NHS Foundation Trust | Completed | Manchester | Lancanshire | M20 4BX | United Kingdom |
| Lancashire Clinical Research Facility, Royal Preston Hospital | Completed | Preston | Lancanshire | PR2 9HT | United Kingdom |
| Guy's and St Thomas's Hospital | Completed | London | London, City of | SE1 9RT | United Kingdom |
| Mount Vernon Cancer Centre | Completed | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Velindre Cancer Centre-PPDS | Completed | Cardiff | South Glamorgan | CF14 2TL | United Kingdom |
| The Royal Marsden in Sutton | Withdrawn | Sutton | Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016889 | Endometrial Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000230 | Adenocarcinoma |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C000718069 | MORAb-202 |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| D003907 | Dexamethasone |
| C531958 | lenvatinib |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
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