Trial · NCT03449030
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) | Baseline up to Month 22 | The safety population was defined as all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Grade 3 or Above AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Drug-related AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Drug-related Grade 3 or Above AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Events (SAEs) | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With AEs Leading to Discontinuation | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | Pharmacokinetic (PK) analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A. | ||
| SECONDARY | Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A. | ||
| SECONDARY | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A. | ||
| SECONDARY | Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A. | ||
| SECONDARY | Overall Response Rate (ORR) | From start of study treatment until the start of subsequent anti cancer therapy ( up to Month 22) | The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Baseline up to Month 22 | The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-Baseline disease assessment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From the date of first documentation of a response (CR or PR) to the date of first documented PD or death due to any cause, whichever occurred first (up to 22 months) | The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events CR or PR. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From date of first study drug administration to the day of first documented PD or death due to any cause, whichever occurred first (up to 22 months) | The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post-baseline disease assessment. Here 'N' (Overall number of participants analyzed) signifies participants with events (PD or/and death). | months | MEDIAN |
| SECONDARY | Number of Participants With Positive Antidrug Antibody (ADA) Levels in Serum | Baseline up to Month 22 | The immunogenicity evaluable population was defined as all participants with a baseline immunogenicity assessment and at least 1 postbaseline immunogenicity assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Recommended Phase 2 Dose (RP2D) of TAK-164 | Baseline up to Month 22 | The safety population was defined as all participants who received at least 1 dose of study drug. | mg/kg | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT03449030/outcomes