Trial · NCT04702737
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Up to approximately 3 years | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced One or More Treatment-related Adverse Events (TRAE) | Up to approximately 3 years | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Up to 28 days | DLT Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab with an evaluable DLT endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 3 years | Evaluable by Central Reviewer Analysis Set: all participants who were enrolled, received at least 1 dose of tarlatamab, had measurable baseline disease per RECIST 1.1 with PCWG3 modifications as assessed by a central reviewer. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 3 years | Evaluable by Central Reviewer Analysis Set: all participants who were enrolled, received at least 1 dose of tarlatamab, had measurable baseline disease per RECIST 1.1 with PCWG3 modifications as assessed by a central reviewer. Only participants with a confirmed response have been included here. | months | MEDIAN |
| SECONDARY | Radiographic Progression-free Survival (PFS) | Up to approximately 3 years | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. Censoring was at the last evaluable disease assessment date (tumor assessment or bone scan). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 3 years | Safety Analysis Set: all participants who were enrolled and received at least 1 dose of tarlatamab. Among the 40 participants included in the Safety Analysis Set, 35 participants died because of any cause and 5 participants were censored. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 3 years | Evaluable by Central Reviewer Analysis Set: all participants who were enrolled, received at least 1 dose of tarlatamab, had measurable baseline disease per RECIST 1.1 with PCWG3 modifications as assessed by a central reviewer. | percentage of participants | NUMBER |
| SECONDARY | Maximum Serum Concentration (Cmax) of Tarlatamab | Cycle 2 Day 1 and Day 15: Predose, end of infusion (EOI), 2, 6, 24, 48, 96 and 168 hours after EOI | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The total number of participants analyzed includes only participants with available data at pre-specified timepoints. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Tarlatamab Concentration at the End of a Dosing Interval or Before Planned Next Dose (Ctrough) | Cycle 2 Day 15: Predose | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The number of participants analyzed only includes participants with available data for each timepoint. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-time Curve Over the Dosing Interval From Time 0 to 336 Hours (AUC336) of Tarlatamab | Cycle 2 Day 1 and Day 15: Predose, EOI, 2, 6, 24, 48, 96, 168, and 336 hours after EOI | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The number of participants analyzed only includes participants with available data for each timepoint. | hr*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Terminal Phase Elimination Half-life (t1/2,z) of Tarlatamab | Cycle 2 Day 15: Predose, EOI, 2, 6, 24, 48, 96 and 168 hours after EOI | PK Analysis Set: all participants who received at least 1 dose of tarlatamab and had at least 1 PK sample collected. The number of participants analyzed only includes participants with available data for each timepoint. | days | GEOMETRIC_MEAN |
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
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GET https://conductscience.org/api/trials/v1/NCT04702737/outcomes