Trial · NCT07905001
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicity of PRT13722 (Parts 1A and 2) | Through cycle 1 (28 days) | Incidence of dose limiting toxicities, defined according to protocol-specified criteria |
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of PRT13722 as monotherapy and in combination (Parts 1A and 2) | Through study completion, an average of 2 years | Safety and tolerability assessed by the number of participants with treatment-emergent adverse events, serious adverse events, adverse events leading to dose modification, treatment interruption, or treatment discontinuation, and clinically significant laboratory abnormalities. Adverse events and selected laboratory abnormalities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0 |
| Primary | Preliminary Antitumor Activity: Objective Response Rate (Parts 1B and 3) | Through study completion, an average of 2 years | Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1 |
| Secondary | Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2) | Through study completion, an average of 2 years | Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1 |
| Secondary | Duration of Response | Through study completion, an average of 2 years | Time from first documented response to disease progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first. |
| Secondary | Clinical Benefit Response | Through study completion, an average of 2 years | Proportion of patients with a best overall response of complete response, partial response, or durable stable disease (24 weeks or longer), as assessed by the investigator per RECIST v1.1 |
| Secondary | Progression-Free Survival | Through study completion, an average of 2 years | Time from the date of first dose of investigational product to the date of first documented disease progression, as assessed by the investigator per RECIST v1.1, or death due to any cause |
| Secondary | Overall Survival | Through study completion, an average of 2 years | Time from the date of first dose of investigational product to death due to any cause |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] of PRT13722 as Monotherapy and in Combination (Parts 1B and 3) | Through study completion, an average of 2 years | Safety and tolerability will be evaluated by incidence of adverse events leading to dose modifications, treatment interruptions, treatment discontinuations, and clinically significant laboratory abnormalities graded according to NCI CTCAE, Version 6.0 |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days) | Maximum observed plasma concentration will be calculated using non-compartmental analysis |
| Secondary | Time To Maximum Concentration (Tmax) | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days) | Time to maximum concentration will be calculated using non-compartmental analysis |
| Secondary | Terminal Elimination Half-life (T1/2) | Cycle 1 Day 1 (each cycle is 28 days) | Terminal elimination half-life will be calculated using non-compartmental analysis |
| Secondary | Area under the plasma concentration versus time curve (AUC) | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days) | Area under the plasma concentration-time curve will be calculated using non-compartmental analysis |
| Secondary | Steady State Trough Concentrations | Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days) | Steady state trough concentrations will be calculated using non-compartmental analysis |
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.
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GET https://conductscience.org/api/trials/v1/NCT07905001/registered