Trial Title:
Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma
NCT ID:
NCT06341712
Condition:
Osteosarcoma
Osteosarcoma in Children
Osteosarcoma in Adolescents and Young Adults
Conditions: Official terms:
Osteosarcoma
Conditions: Keywords:
Osteosarcoma
Cabozantinib
Children
Osteosarcoma in adolescents and young adults (AYA)
AYA
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:
Cabozantinib
Description:
Participants will receive cabozantinib orally Once daily (QD) on a continuous dosing
schedule for cycles of 28 days.
Arm group label:
Arm A: Cabozantinib+ Best supportive care (BSC)
Intervention type:
Other
Intervention name:
Best Supportive Care (BSC)
Description:
Participants will receive BSC. BSC includes antibiotics, nutritional support, correction
of metabolic disorders, optimal symptom control and pain management (including palliative
radiotherapy), etc. but does not include tumor specific therapy.
Arm group label:
Arm A: Cabozantinib+ Best supportive care (BSC)
Intervention type:
Other
Intervention name:
Best Supportive Care (BSC)
Description:
Participants will receive BSC alone. BSC includes antibiotics, nutritional support,
correction of metabolic disorders, optimal symptom control and pain management (including
palliative radiotherapy), etc. but does not include tumor specific therapy.
Arm group label:
Arm B: Best supportive care (BSC)
Summary:
The participants of this study will be children, adolescents, and young adults with
residual osteosarcoma, which cannot be removed completely through surgery.
Participants will have achieved a partial response or stable disease at the end of
conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make
immature bone cells, known as osteoid.
Osteosarcoma is very rare, but it is the most common type of bone cancer in children and
teens. It is most common in teens and young adults.
In this study, participants will receive either cabozantinib and best supportive care or
the best supportive care alone. Best supportive care will be provided at the
investigator's discretion and according to institutional guidelines.
It includes antibiotics, nutritional support, correction of metabolic disorders, optimal
symptom control and pain management (including radiotherapy), etc. but does not include
tumor specific therapy.
Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will
be provided to participants who tolerate it for as long as their disease does not
progress. Participants in the study receiving best supportive care alone may switch to
treatment with cabozantinib and best supportive care if their disease progresses and if
other eligibility criteria are met.
Participants may withdraw consent to participate at any time.
The estimated duration of the study for participants is 24 months, however a participant
could remain in the study longer if demonstrating treatment benefit.
Criteria for eligibility:
Criteria:
Inclusion Criteria :
- Participants must be ≥5 and ≤30 years of age at the time of study entry.
- Histologically or cytologically confirmed diagnosis of high-grade osteosarcoma as
defined by a local pathologist
- Participants with unresectable residual disease after standard chemotherapy
treatment at diagnosis or first relapse (treated with systemic chemotherapy). A
minimum of 4 cycles of systemic chemotherapy (or minimum of 2 cycles if chemotherapy
was stopped early due to toxicity) must have been received.
- Measurable residual or evaluable disease by RECIST version 1.1. Participants will be
considered with evaluable disease if they have only non-measurable disease as per
RECIST version 1.1 criteria.
- Absence of Progressive Disease (PD) (defined by the investigator according to RECIST
version 1.1) at study entry. Note, the two most recent radiological evaluations
(e.g. computerised tomography (CT) or magnetic resonance resonance imaging (MRI)
scan) including the one following completion of chemotherapy should be available
later to facilitate BIRC review.
- Chemotherapy must be the last anticancer treatment received by participants before
study entry and must have been completed at least 4 weeks but no longer than 2
months before randomization.
- Participants must have recovered to Grade ≤1, except for alopecia, ototoxicity, and
Grade ≤2 peripheral neuropathy, per Common Terminology Criteria for Adverse Events
(CTCAE) version 5.0) from the acute toxic effects of all prior anticancer therapy at
study entry, unless AEs are clinically non significant and/or stable on supportive
therapy, per investigator clinical judgment.
- Life expectancy >6 months.
- Performance level: participants must have a Lansky or Karnofsky performance status
score of ≥70 corresponding to Eastern Cooperative Oncology Group (ECOG) categories
0-1.
- Adequate organ and marrow function.
- Adequately controlled blood pressure (BP) with or without antihypertensive
medications.
- Male and/or female (according to their reproductive organs and functions assigned by
chromosomal complement) (FDA 2016)
- Contraception and barriers as well as pregnancy testing is required as appropriate
for the age and sexual activity of pediatric participants and as required by local
regulations.
- All participants (typically ≥18 years) and/or their parents or legal guardians must
sign a written informed consent and assent must be obtained from minor participants
according to local guidelines.
Exclusion Criteria :
- Low grade osteosarcoma and periosteal osteosarcoma
- Previous treatment with cabozantinib or another Mesenchymal-epithelial transition
(MET)/hepatocyte growth factor (HGF) inhibitor (e.g., tivantinib, crizotinib).
- Receipt of any type of small molecule kinase inhibitor (including investigational
kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer,
before first dose of study intervention.
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy
(including investigational) within 4 weeks before first dose of study intervention
(or washout of at least 5 half-lives, whichever is shorter).
- Known brain metastases or cranial epidural disease unless adequately treated with
radiotherapy and/or surgery (including radiosurgery or major surgery e.g., removal
or biopsy of brain metastasis) and stable for at least 4 weeks prior to
randomization. Eligible participants must be neurologically asymptomatic and without
systemic corticosteroid treatment at the time of randomization. Note: Participants
with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants
and have well-controlled seizures on a stable dose of anti-convulsant may be
enrolled.
- Participants who have an uncontrolled/active infection requiring systemic therapy.
- Participants who are unable to swallow intact tablets.
- Participants with uncontrolled, significant intercurrent or recent illness.
- Previously identified allergy or hypersensitivity to components of the study
treatment formulations.
- Any other active malignancy at time of first dose of study intervention or diagnosis
of another malignancy within 3 years prior to first dose of study intervention that
requires active treatment.
- Pregnancy or breast-feeding.
- Participants who in the opinion of the investigator may not be able to comply with
the requirements of the study are not eligible
- Major surgery (eg, orthopaedic surgery, removal or biopsy of brain metastasis)
within 8 weeks before randomization. Complete wound healing from major surgery must
have occurred 4 weeks before randomization and from minor surgery (eg, simple
excision, tooth extraction) at least 10 days before randomization. Participants with
clinically relevant ongoing complications from prior surgery are not eligible.
Gender:
All
Minimum age:
5 Years
Maximum age:
30 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California (USC) - Norris Cancer Hospital
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Stanford University and Lucile Packard Children's Hospital
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Florida Health Shands Children's Hospital
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Levine Children's Hospital (LCH)
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Cincinnati Children's Hospital Medical Center - Cancer and Blood Diseases Institute (CBDI)
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
MD Anderson Main Campus
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Children's Hospital of the King's Daughters
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
St. Anna Kinderspital Zentrum fuer Kinder- und Jugendheilkunde
Address:
City:
Vienna
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Cliniques universitaires Saint-Luc
Address:
City:
Bruxelles
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
University Hospital Gent
Address:
City:
Ghent
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Universitaire Ziekenhuizen Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Princess Margaret cancer center
Address:
City:
Toronto
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Sinai Health System-Mount Sinai Hospital
Address:
City:
Toronto
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Country:
Denmark
Status:
Not yet recruiting
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Nantes
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Facility:
Name:
AP-HP Hopital Cochin
Address:
City:
Paris
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Poitiers (Poitiers)
Address:
City:
Poitiers
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHU de Rouen - Hôpital Charles-Nicolle
Address:
City:
Rouen
Country:
France
Status:
Recruiting
Facility:
Name:
CHRU de Strasbourg - Hopital de Hautepierre
Address:
City:
Strasbourg
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Toulouse - Hôpital des Enfants
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Facility:
Name:
Charité - Kinderonkologie
Address:
City:
Berlin
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Klinikum Dortmund
Address:
City:
Dortmund
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitätsklinikum Essen Westdeutsches Tumorzentrum Essen
Address:
City:
Essen
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Klinikum Kassel Gesundheit Nordhessen
Address:
City:
Kassel
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Köln - Kinderonkologie
Address:
City:
Köln
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitätsmedizin Mainz
Address:
City:
Mainz
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Dr. von Haunerschen Kinderspital
Address:
City:
München
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Medizinischen Klinik III - Onkologie und Hämatologie - am LMU Klinikum, München
Address:
City:
München
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Olgahospital
Address:
City:
Stuttgart
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
St Vincent's University Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Facility:
Name:
Ospedale Ortopedico Rizzoli di Bologna
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Meyer
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Istituto Giannina Gaslini
Address:
City:
Genova
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Istituto Nazionale Tumor
Address:
City:
Naples
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedale - Università Padova
Address:
City:
Padova
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
AOU Città della Salute e della Scienza di Torino
Address:
City:
Piemonte
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
IRCCS - Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Ospedale Paediatrico Bambino Gesù
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria Senese
Address:
City:
Siena
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Facility:
Name:
Amsterdam UMC - Locatie AMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Princess Maxima Center for paediatric oncology
Address:
City:
Utrecht
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Instytut Matki i Dziecka
Address:
City:
Warsaw
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hospital de La Santa Creu i Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Sant Joan de Deu
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital General Unversitario Gregorio Marañón (Madrid)
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Unversitario Gregorio Marañón
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Infantil Universitario Nino Jesus
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Son Espases
Address:
City:
Palma De Mallorca
Country:
Spain
Status:
Recruiting
Facility:
Name:
Complejo Hospitalario Universitario de Santiago
Address:
City:
Santiago De Compostela
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari i Politecnic La Fe
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Birmingham Children's Hospital
Address:
City:
Birmingham
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Cambridge University Hospitals NHS Trust
Address:
City:
Cambridge
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
NHS greater Glasgow and Clyde
Address:
City:
Glasgow
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
University College London Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Christie NHS Foundation Trust
Address:
City:
Manchester
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Royal Victoria Infirmary
Address:
City:
Newcastle Upon Tyne
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
October 31, 2024
Completion date:
June 15, 2028
Lead sponsor:
Agency:
Ipsen
Agency class:
Industry
Source:
Ipsen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341712
