Trial · NCT04381650
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Up to approximately 24 months | An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS. |
| Primary | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to Cycle 1 (each cycle was of 21 days) | DLTs were evaluated according to NCI CTCAE Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS. |
| Primary | Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | Up to approximately 24 months | AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT Consensus Grading for CRS. |
| Primary | Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs) | Up to approximately 24 months | An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. |
| Primary | Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation | Up to approximately 24 months | An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. |
| Primary | Phase 1: Number of Participants With Clinically Significant Laboratory Values | Up to approximately 24 months | Laboratory parameters included clinical chemistry, hematology, and urinalysis. Participants with at least 1 Grade 3 or 4 Lab Abnormalities were reported. |
| Primary | Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to RECIST, Version 1.1 | Up to approximately 25 months | ORR is defined as the percentage of participants who achieve Complete Response (CR) and Partial Response (PR) (determined by the investigator) during the study according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. |
| Secondary | Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: t1/2z: Terminal Disposition Phase Half-life for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: CL: Total Clearance After Intravenous Administration for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phase 1: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-981 | Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) | |
| Secondary | Phases 1 and 2: Disease Control Rate (DCR) | Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months | DCR is defined as the percentage of participants who achieved stable disease (SD) or better (CR + PR + SD determined by the investigator) \>6 weeks during the trial in the response-evaluable population. |
| Secondary | Phases 1 and 2: Durable Response Rate (DRR) | Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months | DRR is defined as the rate of objective responses (CR + PR) maintained for at least 6 months initiating at any time within 12 months of commencing therapy. |
| Secondary | Phases 1 and 2: Duration of Response (DOR) | Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months | DOR is defined as a time from the time of first documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study. |
| Secondary | Phases 1 and 2: Progression-free Survival (PFS) | Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months | PFS is defined as time from the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study. |
| Secondary | Phases 1 and 2: Time to Response (TTR) | Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months | TTR is defined as time from the date of the first dose administration to the date of first documented PR or better. |
| Secondary | Phases 1 and 2: Time to Progression (TTP) | Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months | TTP is defined as the from the date of the first dose administration to the date of the first documentation of PD as defined by standard disease criteria. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04381650/registered