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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-OX-JZJJ | Other Identifier | Eli Lilly and Company | |
| LOXO-RET-18036 | Other Identifier | LOXO Oncology, Inc. | |
| 2019-000212-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Medullary Thyroid Cancer (MTC) Group | Experimental | Participants in this cohort had MTC and received 160 mg of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
|
| Cohort 2: Papillary Thyroid Cancer (PTC) Group | Experimental | Participants in this cohort had PTC and received 160 mg of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
|
| Cohort 3: Other Cancer Group | Experimental | Participants in this cohort had other (REarranged during Transfection (RET)-altered non-thyroid) cancer and received 160 mg of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selpercatinib | Drug | Oral LOXO-292 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was any of the adverse events that starts on or after the first administration of study drug listed below, as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
| Cycle 1 (28 Day Cycle) |
| Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study | ORR: Percentage of participants who achieve best overall response Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST).
| Date of first dose to disease progression or death (Up to 62.4 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of LOXO-292 | Outcome data will be provided after the study is completed. | Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) |
| Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of LOXO-292 |
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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 Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| The Children's Hospital for Cancer and Blood Disorders |
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In Phase 2, participants were assigned to one of three disease-based groups: medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), or Other Solid Tumors and received selpercatinib at the RP2D. Current primary results are reported, and additional results will be reported during study completion.
The study consisted of two parts: Phase 1 (dose-escalation) and Phase 2 (dose-expansion). In Phase 1, three participants received selpercatinib, with dosing based on body surface area. The starting dose level was 92 mg/m^2 (maximum 160 mg, twice daily (BID]), selected to approximate the exposure associated with the recommended Phase 2 dose (RP2D) in adults. The Phase 2 portion opened for enrollment after confirmation of the RP2D of 92 mg/m^2 (maximum 160 mg BID).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation Cohort (Phase 1) | Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m^2 BID (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults. |
| FG001 | Cohort 1 (Phase 2): Medullary Thyroid Cancer (MTC) Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2025 | Sep 19, 2025 |
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Outcome data will be provided after the study is completed. |
| Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) |
| Maximum Concentration (Cmax) of LOXO-292 | Outcome data will be provided after the study is completed. | Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) |
| Time to Maximum Concentration (Tmax) of LOXO-292 | Outcome data will be provided after the study is completed. | Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) |
| Recommended LOXO-292 Dose for Phase 2 (MTD) | Outcome data will be provided after the study is completed. | Cycle 1 (28 days) |
| To Assess the Preliminary Anti-Tumor Activity of LOXO-292 in Pediatric Participants With Tumors Harboring an Activating RET Alteration as Determined by ORR Based on RECIST v1.1 | Outcome data will be provided after the study is completed. | Baseline to Progressive Disease or Death due to any cause (Estimated up to 12 months) |
| Changes From Baseline in Pain Measures as Measured by Wong Baker Faces Scales. Wong-Baker Faces Pain Scale Includes Pictures of Facial Expressions With Correlating Scores of 0 Being 'no Hurt' and 10 Being 'Hurts Worst'. | Outcome data will be provided after the study is completed. | Up to 24 months |
| Changes From Baseline in Health Related Quality of Life Measures as Measured by Pediatric Quality of Life (PedsQoL) Inventory Core. PedsQoL Includes a List of Problems With Scores of 0 Being 'Never a Problem' and 4 Being 'Almost Always a Problem'. | Outcome data will be provided after the study is completed. | Up to 24 months |
| Objective Response Rate as Assessed by RECIST v1.1, as Assessed by Investigator | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Objective Response Rate as Assessed by RANO, as Assessed by Investigator | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Duration of Response (DOR) as Assessed by Investigator | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Duration of Response (DOR) as Assessed by the IRC | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Progression Free Survival (PFS) as Assessed by Investigator | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| PFS as Assessed by IRC | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Overall Survival (OS) | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Clinical Benefit Rate (by Investigator) | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Clinical Benefit Rate (by IRC) | Outcome data will be provided after the study is completed. | Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed. |
| Frequency of Adverse Events (AEs) | Outcome data will be provided after the study is completed. | From the time of informed consent, for approximately 24 months (or earlier if the participants discontinues from the study), and through Safety Follow-up (28 days after the last dose) |
| To Evaluate the Concordance of Prior Molecular That Detected a RET Alteration Within the Participant's Tumor With Diagnostic Tests Being Evaluated by Sponsor | Outcome data will be provided after the study is completed. | 6 months |
| Phase 2: Post-Operative Stage on Participants Treated With LOXO-292 | Tumor stage is described according to the Tumor, Node, Metastasis (TNM)Classification of malignant tumors of the Union for International Cancer Control (UICC). Outcome data will be provided after the study is completed. | Up to 3 years |
| Phase 2: Surgical Margin Status in Participants Treated With LOXO-292 | Tumor margins after surgery are classified into four groups using the International Cancer Control (UICC)-R classification and the Intergroup Rhabdomyosarcoma Staging (IRS) systems: 1) Complete tumor resection with histologically free margins, 2) Macroscopic resection but invaded margins on histology, 3)Macroscopic residual tumor and 4) Distant metastatic tumor. Outcome data will be provided after the study is completed. | Up to 3 years |
| Descriptive Analysis of Pretreatment Surgical Plan | Outcome data will be provided after the study is completed. | Up to 3 years |
| Descriptive Analysis of Post-Treatment Plans | Outcome data will be provided after the study is completed. | Up to 3 years |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Nemours Children's Health | Orlando | Florida | 32827 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Minnesota Hospital | Minneapolis | Minnesota | 55455 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390-9063 | United States |
| Texas Childrens Hospital | Houston | Texas | 77025 | United States |
| Seattle Children's Hospital Research Foundation | Seattle | Washington | 98105 | United States |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Royal Children's Hospital | Melbourne | Victoria | 3052 | Australia |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Rigshospitalet | Copenhagen | 2200 | Denmark |
| Gustave Roussy | Villejuif | 94805 | France |
| Universitätsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Seoul National University Hospital | Seoul | Korea | 03080 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 8035 | Spain |
| University College Hospital - London | London | Greater London | NW1 2BU | United Kingdom |
Participants in this cohort had MTC and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
| FG002 | Cohort 2 (Phase 2): Papillary Thyroid Cancer (PTC) Group | Participants in this cohort had PTC and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
| FG003 | Cohort 3 (Phase 2): Other Cancer Group | Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
| COMPLETED |
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| NOT COMPLETED |
|
| Phase 2 |
|
|
All participants who received at least one dose of study drug. The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation Cohort (Phase 1) | Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m^2 (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults. |
| BG001 | Cohort 1 (Phase 2): MTC Group | Participants in this cohort had MTC and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
| BG002 | Cohort 2 (Phase 2): PTC Group | Participants in this cohort had PTC and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
| BG003 | Cohort 3 (Phase 2): Other Cancer Group | Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study. | Count of Participants | Participants | No |
| ||||||||||||||
| Ethnicity (NIH/OMB) | The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study. | Count of Participants | Participants | No |
| ||||||||||||||
| Race (NIH/OMB) | The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study. | 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 | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was any of the adverse events that starts on or after the first administration of study drug listed below, as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
| All participants in Phase 1 of the study who received at least one dose of the study drug. | Posted | Count of Participants | Participants | No | Cycle 1 (28 Day Cycle) |
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| Primary | Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study | ORR: Percentage of participants who achieve best overall response Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST).
| All participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Date of first dose to disease progression or death (Up to 62.4 Months) |
| ||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of LOXO-292 | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of LOXO-292 | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of LOXO-292 | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration (Tmax) of LOXO-292 | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Recommended LOXO-292 Dose for Phase 2 (MTD) | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Cycle 1 (28 days) | Participants | ||||||||||||||||||||||||||||||
| Secondary | To Assess the Preliminary Anti-Tumor Activity of LOXO-292 in Pediatric Participants With Tumors Harboring an Activating RET Alteration as Determined by ORR Based on RECIST v1.1 | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Baseline to Progressive Disease or Death due to any cause (Estimated up to 12 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Pain Measures as Measured by Wong Baker Faces Scales. Wong-Baker Faces Pain Scale Includes Pictures of Facial Expressions With Correlating Scores of 0 Being 'no Hurt' and 10 Being 'Hurts Worst'. | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Up to 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Health Related Quality of Life Measures as Measured by Pediatric Quality of Life (PedsQoL) Inventory Core. PedsQoL Includes a List of Problems With Scores of 0 Being 'Never a Problem' and 4 Being 'Almost Always a Problem'. | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Up to 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate as Assessed by RECIST v1.1, as Assessed by Investigator | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate as Assessed by RANO, as Assessed by Investigator | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Assessed by Investigator | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Assessed by the IRC | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) as Assessed by Investigator | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | PFS as Assessed by IRC | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (by Investigator) | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (by IRC) | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed. | Participants | ||||||||||||||||||||||||||||||
| Secondary | Frequency of Adverse Events (AEs) | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | From the time of informed consent, for approximately 24 months (or earlier if the participants discontinues from the study), and through Safety Follow-up (28 days after the last dose) | Participants | ||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Concordance of Prior Molecular That Detected a RET Alteration Within the Participant's Tumor With Diagnostic Tests Being Evaluated by Sponsor | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | 6 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Post-Operative Stage on Participants Treated With LOXO-292 | Tumor stage is described according to the Tumor, Node, Metastasis (TNM)Classification of malignant tumors of the Union for International Cancer Control (UICC). Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Up to 3 years | Participants | ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Surgical Margin Status in Participants Treated With LOXO-292 | Tumor margins after surgery are classified into four groups using the International Cancer Control (UICC)-R classification and the Intergroup Rhabdomyosarcoma Staging (IRS) systems: 1) Complete tumor resection with histologically free margins, 2) Macroscopic resection but invaded margins on histology, 3)Macroscopic residual tumor and 4) Distant metastatic tumor. Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Up to 3 years | Participants | ||||||||||||||||||||||||||||||
| Secondary | Descriptive Analysis of Pretreatment Surgical Plan | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Up to 3 years | Participants | ||||||||||||||||||||||||||||||
| Secondary | Descriptive Analysis of Post-Treatment Plans | Outcome data will be provided after the study is completed. | Not Posted | May 2029 | Up to 3 years | Participants |
Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
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 | Cohort 1: MTC Group | Participants in this cohort had MTC and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. | 0 | 15 | 8 | 15 | 15 | 15 |
| EG001 | Cohort 2: PTC Group | Participants in this cohort had PTC and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. | 0 | 15 | 4 | 15 | 15 | 15 |
| EG002 | Cohort 3: Other Cancer Group | Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. | 4 | 6 | 3 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 22.0 | Systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal oedema | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lip blister | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tongue eruption | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Medical device site erosion | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aeromonas infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial overgrowth | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Moraxella infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pathogen resistance | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood 1,25-dihydroxycholecalciferol decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood calcitonin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood folate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram qrs complex prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram t wave abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Pregnancy test positive | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Thyroglobulin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Vitamin b12 decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Vitamin d decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vitamin b12 deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sever's disease | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nitrituria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ovarian rupture | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acquired diaphragmatic eventration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Palmoplantar keratoderma | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dental operation | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2024 | Sep 19, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| D018224 | Myofibromatosis |
| D000077273 | Thyroid Cancer, Papillary |
| D012509 | Sarcoma |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D013959 | Thyroid Diseases |
| D013964 | Thyroid Neoplasms |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013899 | Thoracic Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D003110 | Colonic Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D000231 | Adenocarcinoma, Papillary |
| D001982 | Bronchial Diseases |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656166 | selpercatinib |
Not provided
Not provided
Not provided
| Death |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Between 18 and 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| South Korea |
|
| United States |
|
| Japan |
|
| Denmark |
|
| Italy |
|
| France |
|
| Australia |
|
| Germany |
|
| Spain |
|
| Cohort 3 (Phase 2): Other Cancer Group |
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation. |
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|