Clinical trial • Phase IV • Oncology
SELPERCATINIB for Non-small cell lung cancer | Medullary thyroid cancer | Colon cancer | Breast cancer | Pancreatic cancer | Papillary thyroid cancer | Other solid tumors with activating RET alteration
Phase IV trial of SELPERCATINIB for Non-small cell lung cancer | Medullary thyroid cancer | Colon cancer | Breast cancer | Pancreatic cancer | Papillary t…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Medullary thyroid cancer | Colon cancer | Breast cancer | Pancreatic cancer | Papillary thyroid cancer | Other solid tumors with activating RET alteration
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 16-07-2024
Trial design
open-label, none/not specified-controlled Phase IV trial in France, Poland, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Biomarker Stratified
- True: RET activating alteration
- Target Sample Size
- 344
- Trial Duration For Participant
- 84
Eligibility
Recruits 344 Vulnerable population selected. Consent can be provided by the patient or a legally authorized representative. A signed informed consent must be provided prior to any protocol-specific procedures. Study population is adults (≥18 years)..
- Pregnancy Exclusion
- Willingness of men and women of childbearing potential to observe double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 3 months following the last dose of treatment.
- Vulnerable Population
- Vulnerable population selected. Consent can be provided by the patient or a legally authorized representative. A signed informed consent must be provided prior to any protocol-specific procedures. Study population is adults (≥18 years).
Inclusion criteria
- {"criterion_text":"- Patient is diagnosed with a locally advanced or metastatic tumor with evidence of qualifying/activating RET gene alteration who: - is not eligible for an ongoing selpercatinib clinical trial (for example, for clinical, geographic or financial reasons or due to cohort closure), but are deemed appropriate candidates to receive selpercatinib treatment by the treating physician and the Sponsor, and - Has progressed on, are intolerant to standard therapy, or no standard therapy exists -For regions where drug has become regulatory approved, local labeling language should be followed"}
- {"criterion_text":"- Eighteen years of age or older at the time of consent."}
- {"criterion_text":"- Adequate hematologic, renal and hepatic function as defined in Section 5.1."}
- {"criterion_text":"- Ability to provide consent by patient or legally authorized representative."}
- {"criterion_text":"- Provision of a signed informed consent prior to any protocol specific procedures."}
- {"criterion_text":"- Willingness of men and women of childbearing potential to observe double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 3 months following the last dose of treatment."}
Exclusion criteria
- {"criterion_text":"- Major surgery within 14 days prior to C1D1"}
- {"criterion_text":"- Investigational agent (via clinical trial) or anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of selpercatinib unless considered by the treating physician to be safe, within the best interest of the patient and with prior Sponsor approval."}
- {"criterion_text":"- Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of treatment or prolongation of the QT interval corrected for heart rate using ec on more than 1 ECG obtained during the baseline period. Note: Patients who meet this criteria may be enrolled (with a modified dosing strategy) if a clinical rationale exists which is reviewed and agreed upon by the Sponsor. Patients with implanted pacemakers may enter the program without meeting corrected QT interval (QTc) criteria due to non-evaluable measurement."}
Endpoints
Primary endpoints
- {"endpoint_text":"- There are no endpoints or data analysis for this EAP trial.","definition_or_measurement_approach":"No endpoints or data analysis for this EAP trial."}
Secondary endpoints
- {"endpoint_text":"- There are no endpoints or data analysis for this EAP trial.","definition_or_measurement_approach":"No endpoints or data analysis for this EAP trial."}
Recruitment
- Planned Sample Size
- 344
- Recruitment Window Months
- 67
- Consent Approach
- Signed informed consent is required prior to any protocol-specific procedures. Consent may be provided by the patient or a legally authorized representative. Subject information and informed consent forms are available in country-specific languages (documents exist for French, Polish, Italian, Spanish). Participants must be aged 18 years or older; no assent for minors is applicable.
Methods
- Patient Referral, Recruitment, Screening, and/or Retention (explicitly listed as a duty for Unisphere Travel Ltd. Inc.)
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 150
France
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 18-07-2024
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 60
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncologie
- Principal Investigator Name
- Pascale Tomasini
- Principal Investigator Email
- Pascale.TOMASINI@ap-hm.fr
- Contact Person Name
- Pascale Tomasini
- Contact Person Email
- Pascale.TOMASINI@ap-hm.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncologie
- Principal Investigator Name
- Antoine Italiano
- Principal Investigator Email
- a.italiano@bordeaux.unicancer.fr
- Contact Person Name
- Antoine Italiano
- Contact Person Email
- a.italiano@bordeaux.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologie
- Principal Investigator Name
- Benjamin BESSE
- Principal Investigator Email
- Benjamin.BESSE@gustaveroussy.fr
- Contact Person Name
- Benjamin BESSE
- Contact Person Email
- Benjamin.BESSE@gustaveroussy.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 18-07-2024
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oddzial Badan Wczesnych Faz
- Principal Investigator Name
- Iwona Lugowska
- Principal Investigator Email
- iwona.lugowska@nio.gov.pl
- Contact Person Name
- Iwona Lugowska
- Contact Person Email
- iwona.lugowska@nio.gov.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Oddzial Badan Klinicznych Wczesnych Faz
- Principal Investigator Name
- Rafal Dziadziuszko
- Principal Investigator Email
- rafald@gumed.edu.pl
- Contact Person Name
- Rafal Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 39
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Dipartimento di Oncologia ed Ematologia, Struttura Complessa Oncologia Medica 1
- Principal Investigator Name
- Filippo De Braud
- Principal Investigator Email
- filippo.debraud@istitutotumori.mi.it
- Contact Person Name
- Filippo De Braud
- Contact Person Email
- filippo.debraud@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U.O. di Endocrinologia, Ospedale Cisanello
- Principal Investigator Name
- Rossella Elisei
- Principal Investigator Email
- rossella.elisei@unipi.it
- Contact Person Name
- Rossella Elisei
- Contact Person Email
- rossella.elisei@unipi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 33
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- START Early Phase Clinical Trial Program
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Vall D'hebron Institut De Recerca
- Department Name
- Medical Oncology
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Unisphere Travel Ltd. Inc.
- Responsibilities
- Patient Referral, Recruitment, Screening, and/or Retention
- Name
- United Biosource LLC
- Responsibilities
- roles indicated by sponsor duty codes: 1,12,2,5,6,7,9
Third parties
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"United Biosource LLC","duties_or_roles":"codes: 1,12,2,5,6,7,9","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SELPERCATINIB
- Active Substance
- SELPERCATINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- ORAL
- Maximum Dose
- 160 mg
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