Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J2G-GH-JZJK | Other Identifier | Eli Lilly and Company |
Not provided
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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 thyroid cancer (MTC) and other tumors with RET activation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selpercatinib | Experimental | Selpercatinib 160 milligrams (mg) administered orally twice daily (BID). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selpercatinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. | Date of First Dose to Disease Progression or Death (up to 12 Months) |
| Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC | ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. | Date of First Dose to Disease Progression or Death (Up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Enrolled Population: Duration of Response (DoR) as Assessed by IRC | DOR is defined as the number of months from the start date of PR or CR (whichever response is recorded first), and subsequently confirmed, to the date of disease progression or death, whichever occurs earlier. | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| The First Affiated Hospital Of Guangzhou Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39759832 | Derived | Lu S, Cheng Y, Huang D, Sun Y, Wu L, Zhou C, Zhou J, Guo Y, Shao J, Zhang W. Selpercatinib in Chinese patients with RET-fusion-positive non-small-cell lung cancer: updated efficacy and safety analysis from the LIBRETTO-321 phase II trial. Ther Adv Med Oncol. 2025 Jan 1;17:17588359241307199. doi: 10.1177/17588359241307199. eCollection 2025. | |
| 37655205 |
Not provided
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Primary analysis set (PAS) is defined as rearranged transfection (RET) fusion positive non-small cell lung cancer (NSCLC) and thyroid cancer (TC) and RET mutant medullary thyroid cancer (MTC). Enrolled population is defined as all eligible participants.
Enrollment for this study was based on tumor type.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Selpercatinib | 160 milligram (mg) Selpercatinib administered orally twice daily (BID). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2021 | Mar 8, 2022 |
Not provided
Not provided
Not provided
Not provided
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Not provided
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| Enrolled Population: Time to Response (TTR) as Assessed by IRC | TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed. | Date of First Dose to First Occurrence of Confirmed Tumor Response (Up to 6 months) |
| Enrolled Population: Time to Best Response (TTBR) as Assessed by IRC | TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed. | Date of First Dose to First Occurrence of PR (If Subject's Best Overall Response [BOR] is PR) or CR (If Subject's BOR is CR) (Up to 8 months) |
| Enrolled Population: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR, or Stable Disease (SD) With a Duration of At Least 16 or More Weeks as Assessed by IRC | CBR based on the percentage of participants with best overall response of CR, PR, or stable disease (SD) lasting 16 or more weeks following initiation of selpercatinib as assessed by IRC. CR is defined as disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions) and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | Baseline through Disease Progression or Death Due to Any Cause (Up to 12 Months) |
| Enrolled Population: Progression Free Survival (PFS) as Assessed by IRC | PFS is defined as the number of months elapsed between the date of the first dose and the earliest date of documented disease progression or death (whatever the cause). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study) for target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5.0 mm. Progressive disease for non-target lesion is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Baseline to Progressive Disease or Death from Any Cause (Up to 12 Months) |
| Enrolled Population: Overall Survival (OS) | OS is defined as the number of months elapsed between the date of the first dose and the date of death (whatever the cause). Participants who are alive or lost to follow-up as of the data cutoff date will be right-censored. | Baseline to Date of Death from Any Cause (Up to 12 Months) |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Selpercatinib | Serial blood samples for intensive PK monitoring will be collected for 12 participants. | PK: Cycle 1 Day 1: Predose, 1 h, 2, h, 4 h, 8 h, 12 h postdose PK: Cycle 1 Day 8: Predose, 1 h, 2, h, 4 h, 8 h postdose |
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Southern Medical University Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130000 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai/China | 200030 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Lu S, Zheng X, Sun Y, Huang D, Wu L, Ji Q, Zhou C, Zhou J, Guo Y, Ge M, Ding D, Shao J, Zhang W, Gao M, Cheng Y. Patient-reported outcomes following selpercatinib treatment in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer and thyroid cancer, and RET-mutant medullary thyroid cancer in the phase II LIBRETTO-321 trial. Ther Adv Med Oncol. 2023 Aug 25;15:17588359231189429. doi: 10.1177/17588359231189429. eCollection 2023. |
| 37315261 | Derived | Cheng Y, Huang D, Zhou J, Zhou C, Sun Y, Wu L, Guo Y, Jingxin S, Zhang W, Lu S. Intracranial Activity of Selpercatinib in Chinese Patients With Advanced RET Fusion-Positive Non-Small-Cell Lung Cancer in the Phase II LIBRETTO-321 Trial. JCO Precis Oncol. 2023 Jun;7:e2200708. doi: 10.1200/PO.22.00708. |
| 36062046 | Derived | Zheng X, Ji Q, Sun Y, Ge M, Zhang B, Cheng Y, Lei S, Shi F, Guo Y, Li L, Chen L, Shao J, Zhang W, Gao M. Efficacy and safety of selpercatinib in Chinese patients with advanced RET-altered thyroid cancers: results from the phase II LIBRETTO-321 study. Ther Adv Med Oncol. 2022 Aug 29;14:17588359221119318. doi: 10.1177/17588359221119318. eCollection 2022. |
| 35923928 | Derived | Lu S, Cheng Y, Huang D, Sun Y, Wu L, Zhou C, Guo Y, Shao J, Zhang W, Zhou J. Efficacy and safety of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer: a phase II clinical trial (LIBRETTO-321). Ther Adv Med Oncol. 2022 Jul 28;14:17588359221105020. doi: 10.1177/17588359221105020. eCollection 2022. |
| Enrolled: All NSCLC |
|
| Enrolled: All TC |
|
| Enrolled: All MTC |
|
| PAS: RET Fusion Positive NSCLC |
|
| PAS: RET Fusion Positive TC |
|
| PAS: Advance RET-mutant MTC |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Selpercatinib | 160 mg Selpercatinib administered orally BID. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. | All treated participants who have confirmed RET fusion positive solid tumor NSCLC,TC, or RET mutant MTC by central lab, respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Date of First Dose to Disease Progression or Death (up to 12 Months) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC | ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. | All eligible participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Date of First Dose to Disease Progression or Death (Up to 12 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Enrolled Population: Duration of Response (DoR) as Assessed by IRC | DOR is defined as the number of months from the start date of PR or CR (whichever response is recorded first), and subsequently confirmed, to the date of disease progression or death, whichever occurs earlier. | All eligible participants with confirmed response. Number of participants censored: All NSCLC = 30, All TC = 1, and All MTC = 16. | Posted | Median | 95% Confidence Interval | months | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Enrolled Population: Time to Response (TTR) as Assessed by IRC | TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed. | All eligible participants with confirmed response. | Posted | Median | Inter-Quartile Range | months | Date of First Dose to First Occurrence of Confirmed Tumor Response (Up to 6 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Enrolled Population: Time to Best Response (TTBR) as Assessed by IRC | TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed. | All eligible patients with confirmed response. | Posted | Geometric Mean | Inter-Quartile Range | months | Date of First Dose to First Occurrence of PR (If Subject's Best Overall Response [BOR] is PR) or CR (If Subject's BOR is CR) (Up to 8 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Enrolled Population: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR, or Stable Disease (SD) With a Duration of At Least 16 or More Weeks as Assessed by IRC | CBR based on the percentage of participants with best overall response of CR, PR, or stable disease (SD) lasting 16 or more weeks following initiation of selpercatinib as assessed by IRC. CR is defined as disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions) and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | All eligible participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Disease Progression or Death Due to Any Cause (Up to 12 Months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Enrolled Population: Progression Free Survival (PFS) as Assessed by IRC | PFS is defined as the number of months elapsed between the date of the first dose and the earliest date of documented disease progression or death (whatever the cause). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study) for target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5.0 mm. Progressive disease for non-target lesion is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | All eligible participants. Number of participants censored: All NSCLC = 40; All TC = 1, and All MTC = 28 | Posted | Median | 95% Confidence Interval | months | Baseline to Progressive Disease or Death from Any Cause (Up to 12 Months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Enrolled Population: Overall Survival (OS) | OS is defined as the number of months elapsed between the date of the first dose and the date of death (whatever the cause). Participants who are alive or lost to follow-up as of the data cutoff date will be right-censored. | All eligible participants. Number of participants censored: All NSCLC = 42, All TC = 1, and All MTC = 28. | Posted | Median | 95% Confidence Interval | months | Baseline to Date of Death from Any Cause (Up to 12 Months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Selpercatinib | Serial blood samples for intensive PK monitoring will be collected for 12 participants. | All randomized participants who received at least one dose of study drug and had evaluable intensive PK data per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter (ng*h/mL) | PK: Cycle 1 Day 1: Predose, 1 h, 2, h, 4 h, 8 h, 12 h postdose PK: Cycle 1 Day 8: Predose, 1 h, 2, h, 4 h, 8 h postdose |
|
|
Baseline up to 12 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selpercatinib | 160 mg Selpercatinib administered orally twice daily (BID). | 3 | 77 | 17 | 77 | 75 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cushing's syndrome | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thyroid disorder | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Adenosine deaminase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram t wave abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram t wave amplitude decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Globulins decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Thyroxine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Total bile acids increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Tri-iodothyronine decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Urine bilirubin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2021 | Mar 8, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656166 | selpercatinib |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Overall Response (CR/PR) |
|
| OG002 |
| Medullary Thyroid Cancer (All MTC) |
160 mg Selpercatinib administered orally BID. |
|
|
|
|
|
160 mg Selpercatinib administered orally BID. |
|
|
160 mg Selpercatinib administered orally BID.
|
|
|
|