Trial · NCT05879367
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Dose Limiting Toxicities | 8 weeks | Protocol Defined Dose Limiting Toxicities |
| Primary | Incidence of TEAEs All Grades | From enrollment to the follow-up visit 4 weeks after end of treatment | All Grades |
| Primary | Incidence of TEAEs Grade 3+ | From enrollment to the follow-up visit 4 weeks after end of treatment | Grade 3+ |
| Primary | Incidence of TEAEs Serious | From enrollment to the follow-up visit 4 weeks after end of treatment | Serious |
| Primary | Incidence of TEAEs Leading to Discontinuation | From enrollment to the end of treatment | Leading to Discontinuation |
| Primary | Vital Signs (Heart and Respiratory Rate) | From enrollment to the follow-up visit 4 weeks after end of treatment | Change from Baseline in Heart Rate and Respiratory Rate |
| Primary | Vital Signs (Blood Pressure) | From enrollment to the follow-up visit 4 weeks after end of treatment | Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure |
| Primary | Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests | From enrollment to the follow-up visit 4 weeks after end of treatment | Lab abnormalities by CTCAE v5.0 Grade |
| Secondary | Overall Survival | From enrollment to up to 2 years after last dose | Until death or initiation of new anticancer therapy |
| Secondary | Progression Free Survival | From enrollment to the follow-up visit 4 weeks after end of treatment | Per RANO Criteria as assessed by MRI |
| Secondary | Overall Response Rate | From enrollment to the follow-up visit 4 weeks after end of treatment | Per RANO Criteria as assessed by MRI |
| Secondary | Pharmacokinetics Cmax | Baseline to Steady State (2 weeks) | observed maximum concentration |
| Secondary | Pharmacokinetics Cmin | Baseline to Steady State (2 weeks) | observed minimum concentration |
| Secondary | Pharmacokinetics Tmax | Baseline to Steady State (2 weeks) | time of observed maximum concentration |
| Secondary | Pharmacokinetics AUCt | Baseline to Steady State (2 weeks) | area under the concentration-time curve |
| Secondary | Pharmacokinetics lambdaz | Baseline to Steady State (2 weeks) | elimination rate constant |
| Secondary | Pharmacokinetics t 1/2 | Baseline to Steady State (2 weeks) | elimination half life |
| Secondary | QTcF-Concentration Relationship | Baseline to Steady State (2 weeks) | Assessment of change in QTcF relative to plasma concentration of eflornithine |
| Secondary | Assessment of QTcF | Baseline to Steady State (2 weeks) | Change from baseline in QTcF |
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/NCT05879367/registered