Clinical trial • Phase III • Oncology

Imatinib for Gastrointestinal stromal tumor

Phase III trial of Imatinib for Gastrointestinal stromal tumor.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastrointestinal stromal tumor
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
04-09-2024
First CTIS Authorization Date
03-10-2024

Trial design

Randomised, open-label, arm a: imatinib continuation — imatinib administration will be continued for further 24 months after the date of randomisation (for a total duration of 60 months after surgery). arm b: imatinib stop — adjuvant imatinib is stopped on the date of randomisation. (no dose level specified in arms.)-controlled Phase III trial in Austria, Denmark, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Imatinib Continuation — imatinib administration will be continued for further 24 months after the date of randomisation (for a total duration of 60 months after surgery). Arm B: Imatinib Stop — adjuvant imatinib is stopped on the date of randomisation. (No dose level specified in arms.)
Target Sample Size
95
Trial Duration For Participant
1825

Eligibility

Recruits 95 isVulnerablePopulationSelected true. Adults only (Age ≥ 18 years). Informed consent: 'Patient has provided a written, voluntary informed consent prior to study-specific screening procedures.' Patients unable to grant reliable informed consent are excluded ('inability to grant reliable informed consent'). No provision for assent or enrolment of minors is indicated; consent documents are country-specific (subject information and informed consent forms available for Austria, Denmark, Germany, Spain, Netherlands, Norway, Finland, Sweden)..

Pregnancy Exclusion
Female patients who are pregnant or breast-feeding.
Vulnerable Population
isVulnerablePopulationSelected true. Adults only (Age ≥ 18 years). Informed consent: 'Patient has provided a written, voluntary informed consent prior to study-specific screening procedures.' Patients unable to grant reliable informed consent are excluded ('inability to grant reliable informed consent'). No provision for assent or enrolment of minors is indicated; consent documents are country-specific (subject information and informed consent forms available for Austria, Denmark, Germany, Spain, Netherlands, Norway, Finland, Sweden).

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years.\n- Patient has provided a written, voluntary informed consent prior to study-specific screening procedures.\n- Morphological and immunohistological documentation of GIST (immunostaining for KIT [CD117] and/or DOG-1 positive, or mutation of KIT or PDGFRA present in tumour tissue).\n- Macroscopically complete surgical resection of GIST (either R0 or R1 resection).\n- Mutation analysis of KIT and PDGFR genes has been carried out.\n- A high risk of tumour recurrence following surgery and 3 years of adjuvant imatinib defined as one of the following: 1) gastric GIST with mitotic count >10/50 HPFs HPF, high Power field of the microscope) or >10/5mm2, or 2) non-gastric GIST with mitotic count >5/50 HPFs or >5/5 HPFs mm2, or 3) non-gastric GIST treated with neoadjuvant imatinib and initially larger than 10 cm, or 4) tumour rupture Tumour rupture may have occurred before or at surgery. Tumour rupture is defined by spillage of the tumour contents into the abdominal cavity. A core needle biopsy from the tumour, or tumour bleed with no apparent spillage of the tumour contents, are not considered ruptures. If only a small amount of pretreatment tumour tissue is available from a core needle biopsy, it is acceptable to multiply the mitotic count obtained from fewer than 50 HPFs to approximate the counts obtained from 50 HPFs in surgical biopsies, or to multiply the count obtained from a tumour tissue area less than 5 mm2 to approximate the counts obtained from the 5 mm2 area. However, if only minimal amount of tumour tissue is available from a core needle biopsy (from 5 or fewer HPFs, or only 1 mitosis can be identified), multiplication should not be attempted and is not considered acceptable. For further explanation of this expanded high risk classification, please see section 3.2.3.\n- ECOG performance status ≤ 2.\n- Adequate organ function, defined as serum total bilirubin <1.5 x ULN (upper limit of normal), serum AST (SGOT) and ALT (SGPT) <2.5 x ULN, creatinine <1.5 x ULN; blood ANC (neutrophil count) ≥1.0 x 109/L, platelet count ≥100 x 109/L.\n- Female patients of childbearing potential must have a negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must have amenorrhoea for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.\n- Patient willing to be followed up at the study site regardless of the result of randomisation."}

Exclusion criteria

  • {"criterion_text":"- Presence of distant metastases or local recurrence of GIST.\n- Patient has been free of another malignancy for less than 5 years except if the other malignancy is not currently clinically significant nor requiring active intervention, or if the other malignancy is one of the following: basal cell skin cancer, a cervical carcinoma in situ, a small (2 cm or less in diameter) node-negative breast cancer (pT1N0M0), a low Gleason score (<8) local (T1 or T2) prostate cancer. Recent existence of any other malignant disease is not allowed.\n- Patient with Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study entry).\n- Female patients who are pregnant or breast-feeding.\n- Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, severe chronic renal disease, or active uncontrolled infection).\n- Known diagnosis of human immunodeficiency virus (HIV) infection.\n- Patient with a significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.\n- Not willing to donate tumour tissue and/or blood samples for the study molecular studies.\n- Presence of a substitution mutation at PDGFRA codon D842 (usually D842V).\n- Administration of adjuvant imatinib longer than for 3 years is planned regardless of the result of randomisation, or \"life long\" imatinib administration is planned.\n- Prior adjuvant (+ neoadjuvant) therapy with imatinib mesylate for at least 35 months has not been completed, or the total duration of prior adjuvant (+ neoadjuvant) imatinib administration exceeds the total duration of 38 months.\n- Neoadjuvant imatinib for a duration that exceeds 12 months.\n- Longer than 4-week break during adjuvant imatinib administration.\n- The dose of imatinib at completion of 3 years of adjuvant imatinib was 200 mg per day or less or greater than 800 mg per day.\n- Patient has received any investigational anti-cancer agents during adjuvant imatinib or between completion of adjuvant imatinib and the date of randomisation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Recurrence-free survival (RFS). Defined by the time interval between the date of randomisation and the date of first detection of GIST recurrence or death, whichever occurs first. CT/MRI at 6-month intervals during the first 5 years on study in each arm, and then annually.","definition_or_measurement_approach":"Defined as time interval between date of randomisation and date of first detection of GIST recurrence or death, whichever occurs first; radiological surveillance by CT/MRI at 6-month intervals during first 5 years then annually."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival.","definition_or_measurement_approach":"Time to death from any cause (no further definition provided)."}
  • {"endpoint_text":"- GIST-specific survival. The time period between the date of randomisation and the date of death considered to be caused by GIST; patients who die from other causes are censored on the date of death.","definition_or_measurement_approach":"Time between randomisation and death attributed to GIST; deaths from other causes are censored at date of death."}
  • {"endpoint_text":"- Safety.","definition_or_measurement_approach":"Assessment of toxicity/safety in patients treated with imatinib (no additional measurement details provided)."}
  • {"endpoint_text":"- Quality of Life","definition_or_measurement_approach":"Quality of life assessed (no further measurement approach specified)."}

Recruitment

Registry Or Advocacy Recruitment
True, Asoc Grupo Espanol De Investigacion En Sarcomas | Sarcoma Platform Austria
Planned Sample Size
95
Recruitment Window Months
192
Consent Approach
Written, voluntary informed consent is required prior to study-specific screening procedures ('Patient has provided a written, voluntary informed consent prior to study-specific screening procedures.'). Consent is provided by the patient (adults only, Age ≥ 18). Country-specific subject information and informed consent forms are available (documents listed for Austria, Denmark, Germany, Spain, Netherlands, Norway, Finland (Finnish and Swedish), Sweden). Female participants of childbearing potential require a negative pregnancy test within 14 days before dosing; postmenopausal definition and contraception requirements are described; both male and female participants of reproductive potential must agree to effective barrier contraception during study and for up to 3 months after discontinuation. Patients unable to grant reliable informed consent are excluded.

Geography

Total Number Of Sites
43
Total Number Of Participants
205

Austria

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
08-10-2024
Processing Time Days
11
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Medical University Of Graz
Department Name
Abteilung f. Onkologie
Principal Investigator Name
Joanna Szkandera
Principal Investigator Email
joanna.szkandera@medunigraz.at
Contact Person Name
Joanna Szkandera
Contact Person Email
joanna.szkandera@medunigraz.at
Site Name
Medical University Of Vienna
Department Name
Klinik F. Innere Med. I, Onkologie
Principal Investigator Name
Thomas Brodowicz
Principal Investigator Email
thomas.brodowicz@meduniwien.ac.at
Contact Person Name
Thomas Brodowicz
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
IV Interne Abteilung
Principal Investigator Name
Sonja Heibl
Principal Investigator Email
sonja.heibl@klinikum-wegr.at
Contact Person Name
Sonja Heibl
Contact Person Email
sonja.heibl@klinikum-wegr.at

Denmark

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
08-10-2024
Processing Time Days
11
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Aarhus Universitetshospital
Department Name
Department of Oncology
Principal Investigator Name
Philip Black Rossen
Principal Investigator Email
philross@rm.dk
Contact Person Name
Philip Black Rossen
Contact Person Email
philross@rm.dk

Germany

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
10-10-2024
Processing Time Days
13
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
Principal Investigator Name
Marino Venerito
Principal Investigator Email
m.venerito@med.ovgu.de
Contact Person Name
Marino Venerito
Contact Person Email
m.venerito@med.ovgu.de
Site Name
HOPA MVZ GmbH
Department Name
Hämatologisch-Onkologische
Principal Investigator Name
Wiebke Hollburg
Principal Investigator Email
wiebke.hollburg@hopa-hamburg.de
Contact Person Name
Wiebke Hollburg
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Onkologie und Palliativmedizin
Principal Investigator Name
Peter Reichardt
Principal Investigator Email
peter.reichardt@helios-gesundheit.de
Contact Person Name
Peter Reichardt
Site Name
Universitat Heidelberg
Department Name
Spezielle chirurgische Onkologie und Thoraxchirurgie
Principal Investigator Name
Peter Hohenberger
Principal Investigator Email
peter.hohenberger@umm.de
Contact Person Name
Peter Hohenberger
Contact Person Email
peter.hohenberger@umm.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Onkologie, Hämatologie, Immunologie, Rheumatologie, Pulmologie
Principal Investigator Name
Barbara Hermes
Principal Investigator Email
barbara.hermes@med.uni-tuebingen.de
Contact Person Name
Barbara Hermes
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Department of Radiation Oncology
Principal Investigator Name
Lars Lindner
Principal Investigator Email
lars.lindner@med.uni-muenchen.de
Contact Person Name
Lars Lindner
Site Name
Universitaetsklinikum Essen AöR
Department Name
Onkologie
Principal Investigator Name
Sebastian Bauer
Principal Investigator Email
sebastian.bauer@uk-essen.de
Contact Person Name
Sebastian Bauer
Contact Person Email
sebastian.bauer@uk-essen.de

Spain

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
17
Number Of Sites
16
Number Of Participants
50

Sites

Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Oncología Médica
Principal Investigator Name
Marc Cucurull
Principal Investigator Email
mcucurull@iconcologia.net
Contact Person Name
Marc Cucurull
Contact Person Email
mcucurull@iconcologia.net
Site Name
Hospital Universitario La Paz
Department Name
Oncología Médica
Principal Investigator Name
Virginia Martinez Marín
Principal Investigator Email
virgimarin9@hotmail.com
Contact Person Name
Virginia Martinez Marín
Contact Person Email
virgimarin9@hotmail.com
Site Name
Hospital Alvaro Cunqueiro
Department Name
Oncología Médica
Principal Investigator Name
Juan Antonio Carrasco
Principal Investigator Email
juan.antonio.carrasco.alvarez@sergas.es
Contact Person Name
Juan Antonio Carrasco
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología Médica
Principal Investigator Name
Claudia Valverde
Principal Investigator Email
cvalverde@vhio.net
Contact Person Name
Claudia Valverde
Contact Person Email
cvalverde@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncología Médica
Principal Investigator Name
David Vincente
Principal Investigator Email
dvicentebaz@yahoo.es
Contact Person Name
David Vincente
Contact Person Email
dvicentebaz@yahoo.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncología Médica
Principal Investigator Name
Ana Sebio
Principal Investigator Email
ASebio@santpau.cat
Contact Person Name
Ana Sebio
Contact Person Email
ASebio@santpau.cat
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncología Médica
Principal Investigator Name
Ricardo Cubedo
Principal Investigator Email
rcubedo@gmail.com
Contact Person Name
Ricardo Cubedo
Contact Person Email
rcubedo@gmail.com
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Oncología Médica
Principal Investigator Name
Xavier Garcia del Muro
Principal Investigator Email
garciadelmuro@iconcologia.net
Contact Person Name
Xavier Garcia del Muro
Contact Person Email
garciadelmuro@iconcologia.net
Site Name
University Hospital Son Espases
Department Name
Oncología Médica
Principal Investigator Name
Pablo Luna
Principal Investigator Email
pablo.luna@ssib.es
Contact Person Name
Pablo Luna
Contact Person Email
pablo.luna@ssib.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncología Médica
Principal Investigator Name
Héctor Aguilar
Principal Investigator Email
coordinacion@fincivo.org
Contact Person Name
Héctor Aguilar
Contact Person Email
coordinacion@fincivo.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncología Médica
Principal Investigator Name
Nadia Hindi
Principal Investigator Email
nhindi@atbsarc.org
Contact Person Name
Nadia Hindi
Contact Person Email
nhindi@atbsarc.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncología Médica
Principal Investigator Name
Maria Jose Flor Oncala
Principal Investigator Email
mariajflor@hotmail.com
Contact Person Name
Maria Jose Flor Oncala
Contact Person Email
mariajflor@hotmail.com
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Oncología Médica
Principal Investigator Name
Maria J. Safont
Principal Investigator Email
mjsafont@yahoo.es
Contact Person Name
Maria J. Safont
Contact Person Email
mjsafont@yahoo.es
Site Name
Hospital Universitario De Canarias
Department Name
Oncología Médica
Principal Investigator Name
Josefina Cruz
Principal Investigator Email
jcruzjurado@gmail.com
Contact Person Name
Josefina Cruz
Contact Person Email
jcruzjurado@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncología Médica
Principal Investigator Name
Isabel Sevilla
Principal Investigator Email
isevilla02@yahoo.es
Contact Person Name
Isabel Sevilla
Contact Person Email
isevilla02@yahoo.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología Médica
Principal Investigator Name
Rosa Alvarez
Principal Investigator Email
rosa.alvarez.al@gmail.com
Contact Person Name
Rosa Alvarez
Contact Person Email
rosa.alvarez.al@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
10-10-2024
Processing Time Days
13
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Dept of Oncology
Principal Investigator Name
A.J. Gelderblom
Principal Investigator Email
a.j.gelderblom@lumc.nl
Contact Person Name
A.J. Gelderblom
Contact Person Email
a.j.gelderblom@lumc.nl

Norway

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
7
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Helse Bergen HF
Department Name
Department of Cancer Research and medical physics, HUS
Principal Investigator Name
Andreas Wold
Principal Investigator Email
andreas.nyhus.wold@helse-bergen.no
Contact Person Name
Andreas Wold
Site Name
St. Olavs Hospital HF
Department Name
Department of cancer
Principal Investigator Name
Heidi Knobel
Principal Investigator Email
heidi.knobel@stolav.no
Contact Person Name
Heidi Knobel
Contact Person Email
heidi.knobel@stolav.no
Site Name
Oslo University Hospital HF
Department Name
Avdeling for Kreftbehandling
Principal Investigator Name
Kjetil Boye
Principal Investigator Email
pbk@ous-hf.no
Contact Person Name
Kjetil Boye
Contact Person Email
pbk@ous-hf.no

Finland

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
7
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Turku University Hospital
Department Name
Oncology
Principal Investigator Name
Panu Jaakkola
Principal Investigator Email
panu.jaakkola@tyks.fi
Contact Person Name
Panu Jaakkola
Contact Person Email
panu.jaakkola@tyks.fi
Site Name
HUS-Yhtymae (Helsinki)
Department Name
Oncology
Principal Investigator Name
Heikki Joensuu
Principal Investigator Email
heikki.joensuu@hus.fi
Contact Person Name
Heikki Joensuu
Contact Person Email
heikki.joensuu@hus.fi
Site Name
Pori Central Hospital
Department Name
Oncology
Principal Investigator Name
Kalevi Pulkkanen
Principal Investigator Email
pulkkanen@satasairaala.fi
Contact Person Name
Kalevi Pulkkanen
Contact Person Email
pulkkanen@satasairaala.fi
Site Name
Tampere University Hospital
Department Name
Oncology
Principal Investigator Name
Niina Paunu
Principal Investigator Email
niina.paunu@pshp.fi
Contact Person Name
Niina Paunu
Contact Person Email
niina.paunu@pshp.fi
Site Name
Oulu University Hospital
Department Name
Oncology
Principal Investigator Name
Riina Ollikainen
Principal Investigator Email
riina.ollikainen@pohde.fi
Contact Person Name
Riina Ollikainen
Contact Person Email
riina.ollikainen@pohde.fi
Site Name
Kuopio University Hospital
Department Name
Oncology
Principal Investigator Name
Annamarja Lamminmäki
Principal Investigator Email
Annamarja.Lamminmaki@pshyvinvointialue.fi
Contact Person Name
Annamarja Lamminmäki

Sweden

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
03-10-2024
Processing Time Days
6
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Region Vaesterbotten (Umea)
Department Name
Department of Oncology
Principal Investigator Name
Ann-Sofie Johansson
Principal Investigator Email
annsofie.johansson@regionvasterbotten.se
Contact Person Name
Ann-Sofie Johansson
Site Name
Karolinska University Hospital
Department Name
Sarkomcentrum
Principal Investigator Name
Christina Linder-Stragliotto
Principal Investigator Email
christina.linder-stragliotto@sll.se
Contact Person Name
Christina Linder-Stragliotto
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Department of Surgery
Principal Investigator Name
Stefan Lindskog
Principal Investigator Email
Stefan.lindskog@vgregion.se
Contact Person Name
Stefan Lindskog
Contact Person Email
Stefan.lindskog@vgregion.se
Site Name
Linkoping University Hospital Region Ostergotland
Department Name
Department of Oncology
Principal Investigator Name
Maria Östlund
Principal Investigator Email
Maria.Ostlund@regionostergotland.se
Contact Person Name
Maria Östlund
Site Name
Region Oerebro Laen
Department Name
Department of Oncology
Principal Investigator Name
Hanna Ulin Lindgren
Principal Investigator Email
hanna.lindgren-ulin@regionorebrolan.se
Contact Person Name
Hanna Ulin Lindgren
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Oncology
Principal Investigator Name
Mikael Eriksson
Principal Investigator Email
mikael.eriksson@med.lu.se
Contact Person Name
Mikael Eriksson
Contact Person Email
mikael.eriksson@med.lu.se

Sponsor

Primary sponsor

Full Name
Region Skane
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Contract research organisations

Name
Cordes monitoring

Third parties

  • {"country":"Germany","full_name":"Cordes monitoring","duties_or_roles":"sponsorDuties code 1","organisation_type":"Industry"}
  • {"country":"Netherlands","full_name":"Leids Universitair Medisch Centrum (LUMC)","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Austria","full_name":"Sarcoma Platform Austria","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}
  • {"country":"Finland","full_name":"HUS-Yhtymae","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Spain","full_name":"Asoc Grupo Espanol De Investigacion En Sarcomas","duties_or_roles":"sponsorDuties code 1","organisation_type":"Patient organisation/association"}
  • {"country":"Sweden","full_name":"Croak AB","duties_or_roles":"sponsorDuties code 1","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Glivec 100 mg film-coated tablets
Active Substance
Imatinib
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (EU marketing authorisation EU/1/01/198/007 available)
Maximum Dose
400 mg per day

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