Status:
ACTIVE_NOT_RECRUITING
A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation
Lead Sponsor:
Eli Lilly and Company
Conditions:
Solid Tumor
Medullary Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The reason for this study is to see if the study drug selpercatinib is safe and effective in participants in China with rearranged during transfection (RET) fusion-positive solid tumors, medullary thy...
Eligibility Criteria
Inclusion
- Participants with a locally advanced or metastatic solid tumor.
- Evidence of a RET gene alteration in tumor and/or blood.
- Measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, with no sudden deterioration 2 weeks prior to the first dose of study treatment.
- Archived tumor tissue sample available for cohort 1 and 2.
- Cohorts 1 and 2: failed or intolerant to standard of care.
- Cohorts 1-2: enrollment will be restricted to participants with evidence of a RET gene alteration in tumor (i.e., not just blood). However, a positive germline DNA test for a RET gene mutation as defined in the protocol is acceptable in the absence of tumor tissue testing for participants with MTC.
- Cohorts 1-2: at least one measurable lesion as defined by RECIST v1.1 and not previously irradiated (unless progressive disease for the irradiated lesion\[s\] has been radiographically documented).
Exclusion
- Cohorts 1-2, an additional validated oncogenic driver that could cause resistance to selpercatinib treatment if known.
- Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor(s), such as BLU-667, RXDX-105, etc).
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events (CTCAE) Grade 1 except where otherwise noted in this eligibility criteria at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum therapy-related neuropathy.
- Symptomatic primary central nervous system (CNS) tumor, symptomatic CNS metastasis, leptomeningeal carcinomatosis, or untreated spinal cord compression.
- Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds.
- History of Human Immunodeficiency Virus (known HIV 1/2 antibodies positive); participants with unknown HIV status do not need to be tested.
- History of active hepatitis B (known positive hepatitis B surface antigen \[HbsAg\] and quantitative hepatitis B DNA greater than the upper limit of detection of the assay) or C (known positive hepatitis C antibody and quantitative hepatitis C RNA greater than the upper limit of detection of the assay); participants with unknown hepatitis B/hepatitis C status do not need to be tested.
- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required.
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
- Uncontrolled symptomatic hyperthyroidism or hypothyroidism
- Uncontrolled symptomatic hypercalcemia or hypocalcemia.
- Concurrent use of drugs known to prolong QTc.
- Pregnancy or lactation. Breast-feeding should be interrupted when selpercatinib is started; breast-feeding can be resumed 3 months after discontinuation of selpercatinib.
- Active second malignancy other than minor treatment of indolent cancers with prior sponsor approval.
Key Trial Info
Start Date :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2027
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04280081
Start Date
March 16 2020
End Date
November 1 2027
Last Update
April 20 2025
Active Locations (13)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
The First Affiated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
3
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China, 510515
4
Hunan Cancer Hospital
Changsha, Hunan, China, 410013