Trial Title:
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
NCT ID:
NCT05999994
Condition:
Neoplasms
Child
Adolescent
Conditions: Official terms:
Cyclophosphamide
Temozolomide
Gemcitabine
Docetaxel
Irinotecan
Vinorelbine
Ramucirumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ramucirumab
Description:
Administered IV
Arm group label:
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Arm group label:
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Other name:
LY3009806
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Administered orally
Arm group label:
Cyclophosphamide + Vinorelbine (DSRCT ISA)
Arm group label:
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Intervention type:
Drug
Intervention name:
Vinorelbine
Description:
Administered IV
Arm group label:
Cyclophosphamide + Vinorelbine (DSRCT ISA)
Arm group label:
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Administered IV
Arm group label:
Gemcitabine + Docetaxel (SS ISA)
Arm group label:
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Other name:
LY188011
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Administered IV
Arm group label:
Gemcitabine + Docetaxel (SS ISA)
Arm group label:
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
Administered orally
Arm group label:
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Other name:
LY2835219
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Administered IV
Arm group label:
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Arm group label:
Irinotecan + Temozolomide (ES ISA)
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Administered orally
Arm group label:
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Arm group label:
Irinotecan + Temozolomide (ES ISA)
Summary:
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.
Criteria for eligibility:
Criteria:
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.
- Have either measurable or evaluable disease using standard techniques by the
Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- The participant has a Lansky (<16 years of age) or Karnofsky (≥16 years of age)
performance score of at least 50.
- Participants must have discontinued all previous treatments for cancer or
investigational agents greater than or equal to (≥)7 days after the last dose and
must have recovered from clinically significant side effects.
- The participant has adequate hematologic and organ function.
- Female participants of childbearing potential must have a negative urine or serum
pregnancy test within 7 days prior to first dose.
- Both female and male participants of childbearing potential must agree to use highly
effective contraceptive precautions during the trial and for at least 3 months
following the last dose of study drug.
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.
- Participants with severe and/or uncontrolled concurrent medical disease or
psychiatric illness/social situation that, in the opinion of the investigator, could
cause unacceptable safety risks or compromise compliance with the protocol.
- Participants who have active infections requiring therapy.
- Participants who have had allogeneic bone marrow or solid organ transplant.
- Participants who have had, or are planning to have, certain invasive procedures.
- Female participants who are pregnant or breastfeeding.
Gender:
All
Minimum age:
1 Year
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Childrens Hospital of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Gregory Friedman
Email:
Principal Investigator
Facility:
Name:
Phoenix Children's Hospital
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Status:
Recruiting
Contact:
Phone:
6025460990
Investigator:
Last name:
Alok Kirankumar Kothari
Email:
Principal Investigator
Facility:
Name:
Childrens Hospital of Los Angeles
Address:
City:
Los Angeles
Zip:
90027
Country:
United States
Status:
Completed
Facility:
Name:
UCLA Medical Center
Address:
City:
Los Angeles
Zip:
90095-1752
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Noah Federman
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Orange County
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Josephine HaDuong
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Phone:
720-777-6740
Investigator:
Last name:
Margaret Macy
Email:
Principal Investigator
Facility:
Name:
Children's National Medical Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Contact:
Phone:
202-476-4744
Investigator:
Last name:
AeRang Kim
Email:
Principal Investigator
Facility:
Name:
Golisano Children's Hospital of Southwest Florida
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Status:
Recruiting
Contact:
Phone:
239-343-5437
Investigator:
Last name:
Emad Salman
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Phone:
904-953-2000
Investigator:
Last name:
Steven Attia
Email:
Principal Investigator
Facility:
Name:
Children's Healthcare of Atlanta, Inc. at Egleston
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
404-785-0910
Investigator:
Last name:
Thomas Cash
Email:
Principal Investigator
Facility:
Name:
Ann & Robert H Lurie Children's Hospital of Chicago
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Phone:
312-227-4834
Investigator:
Last name:
David Walterhouse
Email:
Principal Investigator
Facility:
Name:
Riley Hospital for Children
Address:
City:
Indianapolis
Zip:
46202-5225
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
617-632-5869
Investigator:
Last name:
Natalie Collins
Email:
Principal Investigator
Facility:
Name:
C.S. Mott Children's Hospital
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
734-615-7790
Investigator:
Last name:
Rajen Mody
Email:
Principal Investigator
Facility:
Name:
University of Minnesota Hospital
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
612-626-3593
Investigator:
Last name:
Emily Greengard
Email:
Principal Investigator
Facility:
Name:
Children's Mercy Hospital
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Status:
Recruiting
Contact:
Phone:
816-302-6808
Investigator:
Last name:
Kevin Ginn
Email:
Principal Investigator
Facility:
Name:
Washington University Medical School
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Phone:
212-639-8856
Investigator:
Last name:
Emily Slotkin
Email:
Principal Investigator
Facility:
Name:
Nationwide Children's Hosp
Address:
City:
Columbus
Zip:
43205-2664
Country:
United States
Status:
Recruiting
Contact:
Phone:
614-355-1202
Investigator:
Last name:
Mark Ranalli
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97201
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
503-494-4671
Investigator:
Last name:
Katrina Winsnes
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Completed
Facility:
Name:
UPMC Children's Hospital of Pittsburgh
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Andrew Bukowinski
Email:
Principal Investigator
Facility:
Name:
Lifespan Cancer Institute
Address:
City:
Providence
Zip:
02906
Country:
United States
Status:
Recruiting
Contact:
Phone:
401-829-6552
Investigator:
Last name:
Bradley DeNardo
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern Medical Center at Dallas
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Theodore Laetsch
Email:
Principal Investigator
Facility:
Name:
Cook Children's Hospital
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Texas Childrens Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Phone:
832-824-4632
Investigator:
Last name:
Jodi Muscal
Email:
Principal Investigator
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Phone:
713-745-6754
Investigator:
Last name:
Najat Daw
Email:
Principal Investigator
Facility:
Name:
Seattle Children's Hospital Research Foundation
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Phone:
206-987-2114
Investigator:
Last name:
Catherine Albert
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
414-456-4170
Investigator:
Last name:
Meghen Browning
Email:
Principal Investigator
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61290365375
Investigator:
Last name:
Vivek Bhadri
Email:
Principal Investigator
Facility:
Name:
The Sydney Children's Hospitals Network
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61298452138
Investigator:
Last name:
Jessica Ryan
Email:
Principal Investigator
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61385598339
Investigator:
Last name:
Jeremy Lewin
Email:
Principal Investigator
Facility:
Name:
Royal Children's Hospital
Address:
City:
Melbourne
Zip:
3052
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Lisa Orme
Email:
Principal Investigator
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Phone:
3293324812
Investigator:
Last name:
Bram De Wilde
Email:
Principal Investigator
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Phone:
33478785126
Investigator:
Last name:
Jean Yves Blay
Email:
Principal Investigator
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69373 CEDE
Country:
France
Status:
Recruiting
Contact:
Phone:
+33478782642
Investigator:
Last name:
Nadege Corradini
Email:
Principal Investigator
Facility:
Name:
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Contact:
Phone:
33547306088
Investigator:
Last name:
Antoine Italiano
Email:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Freiburg
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Recruiting
Contact:
Phone:
4976127043010
Investigator:
Last name:
Simone Hettmer
Email:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Contact:
Phone:
492017232255
Investigator:
Last name:
Uta Dirksen
Email:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Phone:
4940741020622
Investigator:
Last name:
Uwe Richard Kordes
Email:
Principal Investigator
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Antonio Ruggiero
Email:
Principal Investigator
Facility:
Name:
Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Phone:
39022393062
Investigator:
Last name:
Andrea Ferrari
Email:
Principal Investigator
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Alexia Bertuzzi
Email:
Principal Investigator
Facility:
Name:
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Contact:
Phone:
390119933278
Investigator:
Last name:
Massimo Aglietta
Email:
Principal Investigator
Facility:
Name:
IRCCS Istituto Ortopedico Rizzoli
Address:
City:
Bologna
Zip:
40136
Country:
Italy
Status:
Recruiting
Contact:
Phone:
390516366411
Investigator:
Last name:
EMANUELA PALMERINI
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Di Padova
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Phone:
390498215493
Investigator:
Last name:
Gianni Bisogno
Email:
Principal Investigator
Facility:
Name:
Ospedale Bambino Gesu
Address:
City:
Roma
Zip:
00165
Country:
Italy
Status:
Recruiting
Contact:
Phone:
390668592444
Investigator:
Last name:
Giuseppe Maria Milano
Email:
Principal Investigator
Facility:
Name:
Hyogo Prefectural Kobe Children's Hospital
Address:
City:
Kobe
Zip:
650-0047
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Daiichiro Hasegawa
Email:
Principal Investigator
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Phone:
81120023812
Investigator:
Last name:
Chitose Ogawa
Email:
Principal Investigator
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Contact:
Phone:
81120023812
Investigator:
Last name:
Yuhki Koga
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Lucas Moreno Martin Retortillo
Email:
Principal Investigator
Facility:
Name:
Hospital Sant Joan de Déu
Address:
City:
Esplugues de Llobregat
Zip:
8950
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34932532100
Investigator:
Last name:
Jaume Mora Graupera
Email:
Principal Investigator
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Antonio Lopez Pousa
Email:
Principal Investigator
Facility:
Name:
Hospital Infantil Universitario Niño Jesús
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alba Rubio San Simón
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34917277516
Investigator:
Last name:
Andres Redondo Sanchez
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario de Canarias
Address:
City:
La Laguna
Zip:
38320
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Josefina Cruz Jurado
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Phone:
0034934894695
Investigator:
Last name:
Claudia Maria Valverde Morales
Email:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Maria Cristina Mata Fernandez
Email:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Rosa Maria Alvarez Alvarez
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34917277516
Investigator:
Last name:
Andres Redondo Sanchez
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Pedro Rubio
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34955923113
Investigator:
Last name:
Maria Jose Flor Oncala
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34955012593
Investigator:
Last name:
Catalina Marquez-Vega
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari i Politecnic La Fe
Address:
City:
València
Zip:
46026
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Antonio Juan Ribelles
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Phone:
00442073528171
Investigator:
Last name:
ROBIN JONES
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Julia Chisholm
Email:
Principal Investigator
Facility:
Name:
University College Hospital - London
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Contact:
Phone:
00442034479346
Investigator:
Last name:
Sandra Strauss
Email:
Principal Investigator
Facility:
Name:
Royal Manchester Children's Hospital
Address:
City:
Manchester
Zip:
M139WL
Country:
United Kingdom
Status:
Recruiting
Contact:
Phone:
00441617018430
Investigator:
Last name:
Bernadette Brennan
Email:
Principal Investigator
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Contact:
Phone:
01614463000
Investigator:
Last name:
Martin McCabe
Email:
Principal Investigator
Start date:
January 22, 2020
Completion date:
May 2027
Lead sponsor:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
Eli Lilly and Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999994
