Trial · NCT04501614
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Recommended Phase 2 Dose (RP2D) of Ponatinib in Combination With Chemotherapy | Up to Day 35 in Phase 1 | The Safety Population included all participants who received at least 1 dose of ponatinib. | milligrams per square meter (mg/m^2) | NUMBER |
| PRIMARY | Phase 2: Percentage of Participants With Complete Remission (CR) at the End of the Reinduction Block | Up to Day 35 in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 1: Number of Participants With CR at the End of Reinduction Block | Day 35 in Phase 1 | The Safety Population included all participants who received at least 1 dose of ponatinib. Overall number of participants analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Percentage of Ph+ ALL Participants Who Achieved CR at the End of Consolidation Block | Day 70 in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 2: Percentage of Ph+ ALL Participants With Negative Minimal Residual Disease (MRD) Among Those Who Achieved CR | Up to Day 70 (end of consolidation block) in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 2: Percentage of Participants Who Relapsed or Progressed Following Reinduction and Consolidation | Up to 3 years of follow-up in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 2: Event-free Survival (EFS) | Up to 3 years of follow-up in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 2: Progression-free Survival (PFS) | Up to 3 years of follow-up in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 2: Overall Survival (OS) | Up to 3 years of follow-up in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 2: Duration of Response (DOR) | Up to 3 years of follow-up in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 2: Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplantation (HSCT) | Up to 3 years of follow-up in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. | ||
| SECONDARY | Phase 1: Cmax: Maximum Observed Plasma Concentration for Ponatinib | Predose and at multiple timepoints post-dose up to 24 hours on Days 1 and 22 in Phase 1 | The Pharmacokinetic (PK) Analysis Population included all participants in the Phase 1 portion of the study who had sufficient ponatinib dosing data and concentration-time data to permit the calculation of ponatinib PK parameters. Number analyzed is the number of participants with data available for analysis for the specified timepoint. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 1: Tmax: Time of First Occurrence of Cmax for Ponatinib | Predose and at multiple timepoints post-dose up to 24 hours on Days 1 and 22 in Phase 1 | The PK Analysis Population included all participants in the Phase 1 portion of the study who had sufficient ponatinib dosing data and concentration-time data to permit the calculation of ponatinib PK parameters. Number analyzed is the number of participants with data available for analysis for the specified timepoint. | hours | MEDIAN |
| SECONDARY | Phase 1: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ponatinib | Predose and at multiple timepoints post-dose up to 24 hours on Days 1 and 22 in Phase 1 | The PK Analysis Population included all participants in the Phase 1 portion of the study who had sufficient ponatinib dosing data and concentration-time data to permit the calculation of ponatinib PK parameters. Number analyzed is the number of participants with data available for analysis for the specified timepoint. | hours*nanograms/milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Venous Thrombotic/Embolic Events (VTEs), and Adverse Events of Special Interest (AESIs) | Up to 34.8 months in Phase 1 | The Safety Population included all participants who received at least 1 dose of ponatinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Number of Participants With TEAEs, Serious TEAEs, VTEs, and AESIs | Up to 30 days after last dose of ponatinib in Phase 2 | The study enrollment was terminated per protocol due to DLTs observed in both dose cohorts in Phase 1 and the RP2D could not be determined leading to study termination by the Sponsor before Phase 2 could be initiated. No data was collected as no participants were enrolled in Phase 2. |
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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