Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J1Q-MC-JZIA | Other Identifier | Eli Lilly and Company |
Not provided
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Study terminated due to strategic business decision by Eli Lilly and Company.
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The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: 10 milligrams (mg) LY3435151 | Experimental | Participants received intravenous (IV) push or IV bolus infusion of 10 mg LY3435151. |
|
| Part B: LY3435151 + Pembrolizumab Dose Escalation | Experimental | Pembrolizumab was not administered as study was terminated before completion of Part A of the dose escalation period. |
|
| Part C: LY3435151 Dose Expansion | Experimental | Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase. |
|
| Part D: LY3435151 + Pembrolizumab Dose Expansion | Experimental | Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3435151 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs) | A DLT is defined as an Adverse Event that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0:
| Baseline through Cycle 2 (21 Day Cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151. | Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr) |
| PK: Cmax of LY3435151 in Combination With Pembrolizumab |
Not provided
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 |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| National Cancer Center Hospital |
Not provided
| Label | URL |
|---|---|
| A Study of LY3435151 in Participants With Solid Tumors | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg LY3435151 | Participants received 10 milligrams (mg) dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Jan 28, 2020 | Apr 8, 2021 |
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| Pembrolizumab | Drug | Administered IV |
|
PK: Cmax of LY3435151 in Combination with Pembrolizumab. |
| Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles) |
| Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) | Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. | Baseline through Disease Progression or Death (Up to 4 Months) |
| Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease | Disease Control Rate (DCR) is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Baseline through Measured Progressive Disease (Up to 4 Months) |
| Duration of Response (DoR) | DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months) |
| Time to Response (TTR) | Time to response (TTR) is defined as the time from the date of start of treatment to the date measurement criteria for confirmed CR or PR (whichever is first recorded) are first met. For participants who are not known to have achieved CR or PR as of the data inclusion cut-off date, TTR will be censored at the date of the last objective disease assessment prior the date of any subsequent systematic anticancer therapy. | Baseline to Date of CR or PR (Up to 4 Months) |
| Progression Free Survival (PFS) | PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. | Baseline to Objective Progression or Death Due to Any Cause (Up to 4 Months) |
| Chuo-Ku |
| Tokyo |
| 104-0045 |
| Japan |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg LY3435151 | Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs) | A DLT is defined as an Adverse Event that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0:
| Zero participants were analyzed. This outcome was not determined because the study terminated before completion of Part A of the dose escalation period. | Posted | Baseline through Cycle 2 (21 Day Cycles) |
|
| |||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr) |
|
| ||||||||||||||||
| Secondary | PK: Cmax of LY3435151 in Combination With Pembrolizumab | PK: Cmax of LY3435151 in Combination with Pembrolizumab. | Zero participants were analyzed. The study was terminated early and no data was collected. | Posted | Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles) |
|
| |||||||||||||||||||
| Secondary | Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) | Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. | Zero participants were analyzed. The study was terminated early and no data was collected. | Posted | Baseline through Disease Progression or Death (Up to 4 Months) |
|
| |||||||||||||||||||
| Secondary | Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease | Disease Control Rate (DCR) is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Zero participants were analyzed. The study was terminated early and no data was collected. | Posted | Baseline through Measured Progressive Disease (Up to 4 Months) |
|
| |||||||||||||||||||
| Secondary | Duration of Response (DoR) | DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Zero participants were analyzed. The study was terminated early and no data was collected. | Posted | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months) |
|
| |||||||||||||||||||
| Secondary | Time to Response (TTR) | Time to response (TTR) is defined as the time from the date of start of treatment to the date measurement criteria for confirmed CR or PR (whichever is first recorded) are first met. For participants who are not known to have achieved CR or PR as of the data inclusion cut-off date, TTR will be censored at the date of the last objective disease assessment prior the date of any subsequent systematic anticancer therapy. | Zero participants were analyzed. The study was terminated early and no data was collected. | Posted | Baseline to Date of CR or PR (Up to 4 Months) |
|
| |||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. | Zero participants were analyzed. The study was terminated early and no data was collected. | Posted | Baseline to Objective Progression or Death Due to Any Cause (Up to 4 Months) |
|
|
Up to 4 Months
All randomized participants.
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 | 10 mg LY3435151 | Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion. | 0 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Troponin i increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
This study was terminated before completion of the dose escalation phase (Part A), due to strategic business decision made by the company.
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 | Oct 4, 2019 | Apr 8, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002583 | Uterine Cervical Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D051677 | Histiocytoma, Malignant Fibrous |
| D007890 | Leiomyosarcoma |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D009379 | Neoplasms, Muscle Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|