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| ID | Type | Description | Link |
|---|---|---|---|
| J1S-MC-JAAA | Other Identifier | Eli Lilly and Company |
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The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) | Experimental | Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA). |
|
| Cyclophosphamide + Vinorelbine (DSRCT ISA) | Active Comparator | Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA. |
|
| Ramucirumab + Gemcitabine + Docetaxel (SS ISA) | Experimental | Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. |
|
| Gemcitabine + Docetaxel (SS ISA) | Active Comparator | Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA. |
|
| Abemaciclib + Irinotecan + Temozolomide (ES ISA) | Experimental | Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Allocated to Each ISA | Number of Participants Allocated to Each ISA | Baseline up to Week 4 |
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Inclusion Criteria:
Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll.
Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Alabama | Not yet recruiting | Birmingham | Alabama | 35233 | United States |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2019 | Aug 14, 2023 |
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| Irinotecan + Temozolomide (ES ISA) | Active Comparator | Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA. |
|
| Cyclophosphamide | Drug | Administered orally |
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| Vinorelbine | Drug | Administered IV |
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| Gemcitabine | Drug | Administered IV |
|
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| Docetaxel | Drug | Administered IV |
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| Abemaciclib | Drug | Administered orally |
|
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| Irinotecan | Drug | Administered IV |
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| Temozolomide | Drug | Administered orally |
|
| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
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| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
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| Childrens Hospital of Los Angeles | Completed | Los Angeles | California | 90027 | United States |
| UCLA Medical Center | Not yet recruiting | Los Angeles | California | 90095 | United States |
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| Children's Hospital of Orange County | Recruiting | Orange | California | 92868 | United States |
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| Children's Hospital of Colorado | Recruiting | Denver | Colorado | 80218 | United States |
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| Children's National Medical Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Golisano Children's Hospital of Southwest Florida | Recruiting | Fort Myers | Florida | 33908 | United States |
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| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Children's Healthcare of Atlanta, Inc. at Egleston | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
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| Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| Riley Hospital for Children | Active, not recruiting | Indianapolis | Indiana | 46202-5225 | United States |
| Dana-Farber Cancer Institute | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| C.S. Mott Children's Hospital | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
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| University of Minnesota Hospital | Not yet recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Children's Mercy Hospital | Recruiting | Kansas City | Missouri | 64108 | United States |
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| Washington University Medical School | Completed | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Nationwide Children's Hosp | Recruiting | Columbus | Ohio | 43205-2664 | United States |
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| Oregon Health and Science University | Not yet recruiting | Portland | Oregon | 97201 | United States |
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| Children's Hospital of Philadelphia | Completed | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| Lifespan Cancer Institute | Recruiting | Providence | Rhode Island | 02906 | United States |
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| University of Texas Southwestern Medical Center at Dallas | Recruiting | Dallas | Texas | 75390-9063 | United States |
|
| Cook Children's Hospital | Active, not recruiting | Fort Worth | Texas | 76104-2724 | United States |
| Texas Childrens Hospital | Not yet recruiting | Houston | Texas | 77025 | United States |
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| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Seattle Children's Hospital Research Foundation | Recruiting | Seattle | Washington | 98105 | United States |
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| Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Chris O'Brien Lifehouse | Recruiting | Camperdown | 2050 | Australia |
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| Peter MacCallum Cancer Centre | Recruiting | Melbourne | 3000 | Australia |
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| Royal Children's Hospital | Recruiting | Melbourne | 3052 | Australia |
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| The Sydney Children's Hospitals Network | Not yet recruiting | Westmead | 2145 | Australia |
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| UCL- Saint Luc | Recruiting | Brussels | 1200 | Belgium |
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| Universitair Ziekenhuis Gent | Completed | Ghent | 9000 | Belgium |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Recruiting | Bordeaux | 33076 | France |
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| Centre Leon Berard | Not yet recruiting | Lyon | 69008 | France |
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| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
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| Institut Curie | Not yet recruiting | Paris | 75248 | France |
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| Universitaetsklinikum Essen | Recruiting | Essen | 45147 | Germany |
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| Universitaetsklinikum Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
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| Universitaetsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20251 | Germany |
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| IRCCS Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
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| Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia | Recruiting | Candiolo | 10060 | Italy |
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| Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
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| Azienda Ospedaliera Di Padova | Recruiting | Padova | 35128 | Italy |
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| Ospedale Bambino Gesu | Recruiting | Roma | 00165 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Recruiting | Roma | 00168 | Italy |
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| Istituto Clinico Humanitas | Recruiting | Rozzano | 20089 | Italy |
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| National Cancer Center Hospital | Recruiting | Chūōku | 104-0045 | Japan |
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| Kyushu University Hospital | Recruiting | Fukuoka | 812-8582 | Japan |
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| Hyogo Prefectural Kobe Children's Hospital | Recruiting | Kobe | 650-0047 | Japan |
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| Leids Universitair Medisch Centrum | Recruiting | Leiden | 2333 ZA | Netherlands |
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| Prinses Maxima Centrum | Recruiting | Utrecht | 3584 CS | Netherlands |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 8035 | Spain |
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| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | 8950 | Spain |
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| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | 28007 | Spain |
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| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | 28007 | Spain |
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| Hospital Infantil Universitario Niño Jesús | Recruiting | Madrid | 28009 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | 38320 | Spain |
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| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
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| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| University College Hospital - London | Recruiting | London | NW1 2PG | United Kingdom |
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| Royal Marsden Hospital | Recruiting | London | SW3 6JJ | United Kingdom |
|
| Royal Marsden Hospital | Recruiting | London | SW3 6JJ | United Kingdom |
|
| Royal Manchester Children's Hospital | Recruiting | Manchester | M13 9WL | United Kingdom |
|
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D003520 | Cyclophosphamide |
| D000077235 | Vinorelbine |
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| C000590451 | abemaciclib |
| D000077146 | Irinotecan |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
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