A Study of Selpercatinib (LY3527723) in Participants With Rearranged During Transfection (RET)-Altered Cancers in India
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorEli Lilly and Company
About this trial
This study will evaluate the safety of selpercatinib in participants with RET-altered cancers in India. The study will also assess the number of changes and why participants stop study treatment.
For each participant, the study is expected to last 56 weeks and will include up to 16 protocol-specific visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with advanced RET fusion-positive Non-small cell lung cancer (NSCLC) who require systemic therapy
Adults and pediatric participants (greater than or equal to 12 years) with advanced RET-mutant Medullary Thyroid Cancer (MTC) who require systemic therapy
Adults and pediatric participants (greater than or equal to 12 years) with advanced RET fusion-positive thyroid cancer who require systemic therapy, or
Adults and pediatric participants (greater than or equal to 12 years) with advanced or metastatic RET fusion-positive solid tumors with disease progression on or after prior systemic therapies or who have no satisfactory therapeutic options
Disqualifiers
Additional validated oncogenic drivers in NSCLC if known OR have additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment.
Symptomatic central nervous system metastases, carcinomatous meningitis, or untreated spinal cord compression.
Clinically significant active cardiovascular disease or history of heart attack within 6 months, history of Torsades de Pointes, or prolongation of the QTcF >470 milliseconds on more than 1 electrocardiogram (ECG) during screening.
History of human immunodeficiency virus (HIV)
Trial design
Design model
Single group
Treatments tested in this trial
Selpercatinib
DrugTablet administered orally
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: SelpercatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Treatment Emergent Adverse Event(s) (TEAEs)
Time frame
Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)Secondary outcomes
1
Number of Participants Undergoing Dose Modification
Time frame
Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)2
Number of Adverse Events (AEs) Leading to Discontinuation of Study Intervention
Time frame
Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: