Clinical Trials List
Protocol NumberLOXO-IDH-20001
NCT Number(ClinicalTrials.gov Identfier)NCT04603001
2021-01-01 - 2023-12-31
Phase I
Recruiting1
Terminated1
ICD-10C95.10
Chronic leukemia of unspecified cell type not having achieved remission
A Phase 1 Study of Oral LY3410738 in Patients with Advanced Hematologic Malignancies with IDH1 or IDH2 Mutations
-
Trial Applicant
MEDPACE TAIWAN LIMITED
-
Sponsor
Loxo Oncology, Inc on behalf of Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chien-Chin Lin Division of Others -
- 劉家豪 Division of Hematology & Oncology
- Chieh-Lung Cheng Division of General Internal Medicine
- 田豐銘 Division of Hematology & Oncology
- Wen-Chien Chou Division of Others -
- Huai-Hsuan Huang Division of General Internal Medicine
- SHAN-CHI YU Division of Others -
- MING YAO Division of General Internal Medicine
- - - Division of General Internal Medicine
- - - Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzu-Ting Chen Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Ming-Hung Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Advanced Hematologic Malignancies with IDH1 or IDH2 Mutations
Objectives
Primary Outcome Measures :
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) [ Time Frame: Up to 30 months ]
For Dose Escalation
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per the investigator assessment [ Time Frame: Up to 30 months ]
For Dose Expansion
Test Drug
LY3410738
Active Ingredient
LY3410738
Dosage Form
capsule
Dosage
5 mg、25 mg 或 75 mg/capsule
Endpoints
Primary Outcome Measures :
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) [ Time Frame: Up to 30 months ]
For Dose Escalation
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per the investigator assessment [ Time Frame: Up to 30 months ]
For Dose Expansion
Secondary Outcome Measures :
To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating adverse events and treatment emergent adverse events [ Time Frame: Up to 30 months ]
For Dose Escalation
To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points [ Time Frame: Up to 30 months ]
For Dose Escalation
To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma [ Time Frame: Up to 30 months ]
For Dose Escalation
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per investigator assessment [ Time Frame: Up to 30 months ]
For Dose Escalation
To assess the activity of LY3410738 as measured by Best Overall Response per investigator assessment [ Time Frame: Up to 30 months ]
For Dose Expansion
To assess the activity of LY3410738 by Complete Response Rate plus partial hematologic recovery (AML patients) [ Time Frame: Up to 30 months ]
For Dose Expansion
To assess the activity of LY3410738 by Duration of Response [ Time Frame: Up to 30 months ]
For Dose Expansion
To assess the activity of LY3410738 by Hematologic improvement in patients with MDS [ Time Frame: Up to 30 months ]
For Dose Expansion
To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating Adverse events and treatment emergent adverse events [ Time Frame: Up to 30 months ]
For Dose Expansion
To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points [ Time Frame: Up to 30 months ]
For Dose Expansion
To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma. [ Time Frame: Up to 30 months ]
For Dose Expansion
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) [ Time Frame: Up to 30 months ]
For Dose Escalation
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per the investigator assessment [ Time Frame: Up to 30 months ]
For Dose Expansion
Secondary Outcome Measures :
To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating adverse events and treatment emergent adverse events [ Time Frame: Up to 30 months ]
For Dose Escalation
To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points [ Time Frame: Up to 30 months ]
For Dose Escalation
To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma [ Time Frame: Up to 30 months ]
For Dose Escalation
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per investigator assessment [ Time Frame: Up to 30 months ]
For Dose Escalation
To assess the activity of LY3410738 as measured by Best Overall Response per investigator assessment [ Time Frame: Up to 30 months ]
For Dose Expansion
To assess the activity of LY3410738 by Complete Response Rate plus partial hematologic recovery (AML patients) [ Time Frame: Up to 30 months ]
For Dose Expansion
To assess the activity of LY3410738 by Duration of Response [ Time Frame: Up to 30 months ]
For Dose Expansion
To assess the activity of LY3410738 by Hematologic improvement in patients with MDS [ Time Frame: Up to 30 months ]
For Dose Expansion
To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating Adverse events and treatment emergent adverse events [ Time Frame: Up to 30 months ]
For Dose Expansion
To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points [ Time Frame: Up to 30 months ]
For Dose Expansion
To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma. [ Time Frame: Up to 30 months ]
For Dose Expansion
Inclution Criteria
Inclusion Criteria:
Advanced IDH mutant hematologic malignancy
Patients must have received prior therapy
Blasts at least 5% in bone marrow.
Patients must have a qualifying IDH1 R132, IDH2 R140 or IDH2 R172 mutation
Eastern Cooperative Oncology Group (ECOG) 0-2
Adequate organ function
Ability to swallow capsules
Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.
Advanced IDH mutant hematologic malignancy
Patients must have received prior therapy
Blasts at least 5% in bone marrow.
Patients must have a qualifying IDH1 R132, IDH2 R140 or IDH2 R172 mutation
Eastern Cooperative Oncology Group (ECOG) 0-2
Adequate organ function
Ability to swallow capsules
Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.
Exclusion Criteria
Exclusion Criteria:
Investigational agent or anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter; or investigational monoclonal antibody within 4 weeks prior to planned start of LY3410738
Major surgery within 4 weeks prior to planned start of LY3410738.
Active, uncontrolled clinically significant systemic bacterial, viral, fungal or parasitic infection or an unexplained fever > 38.5ºC during screening or on the first day of study drug administration.
Another concurrent malignancy requiring active therapy.
Active central nervous system involvement
Any unresolved toxicities from prior therapy greater than CTCAE v5.0 Grade 2 at the time of starting study treatment except for alopecia.
History of hematopoietic stem cell transplant (HSCT) or CAR-T therapy within 60 days of the first dose of LY3410738
Clinically significant cardiovascular disease
Active hepatitis B (HBV)
Active hepatitis C virus (HCV)
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug
Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong p-gp inhibitor, with the exception of patients being treated with allowed antifungal inhibitors of CYP3A4
Treatment with proton pump inhibitor (PPIs) within 7 days of starting LY3410738
Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or confound the results of the study
Known human immunodeficiency virus (HIV), excluded due to potential drug-drug interactions between anti-retroviral medications and LY3410738
Pregnancy, lactation or plan to breastfeeding during the study or within 30 days of the last dose of study intervention
Known hypersensitivity to any of the components of LY3410738 or its formulation
Investigational agent or anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter; or investigational monoclonal antibody within 4 weeks prior to planned start of LY3410738
Major surgery within 4 weeks prior to planned start of LY3410738.
Active, uncontrolled clinically significant systemic bacterial, viral, fungal or parasitic infection or an unexplained fever > 38.5ºC during screening or on the first day of study drug administration.
Another concurrent malignancy requiring active therapy.
Active central nervous system involvement
Any unresolved toxicities from prior therapy greater than CTCAE v5.0 Grade 2 at the time of starting study treatment except for alopecia.
History of hematopoietic stem cell transplant (HSCT) or CAR-T therapy within 60 days of the first dose of LY3410738
Clinically significant cardiovascular disease
Active hepatitis B (HBV)
Active hepatitis C virus (HCV)
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug
Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong p-gp inhibitor, with the exception of patients being treated with allowed antifungal inhibitors of CYP3A4
Treatment with proton pump inhibitor (PPIs) within 7 days of starting LY3410738
Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or confound the results of the study
Known human immunodeficiency virus (HIV), excluded due to potential drug-drug interactions between anti-retroviral medications and LY3410738
Pregnancy, lactation or plan to breastfeeding during the study or within 30 days of the last dose of study intervention
Known hypersensitivity to any of the components of LY3410738 or its formulation
The Estimated Number of Participants
-
Taiwan
18 participants
-
Global
260 participants
