Trial · NCT03584516
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | up to Day 28 | A DLT was defined as the occurrence of any protocol-defined toxicity with onset up to and including Day 28, except those with a clear alternative explanation. Participants who received at least 21 of 28 doses of study drug at the level assigned or had a DLT were considered evaluable for determining tolerability of the dose. Participants who did not achieve this duration of exposure and did not have a DLT were to be replaced for purposes of toxicity identification. |
| Primary | Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | until at least 30 days after the last dose of study treatment (up to 1103 days) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. |
| Primary | Part 2: Response Rate at Month 6 | Month 6 | Response rate was defined as the percentage of participants that had complete response (CR) or partial response (PR), per National Institutes of Health (NIH) Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs. |
| Secondary | Part 1 Expansion: Response Rate at Months 3 and 6 | Months 3 and 6 | Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs. |
| Secondary | Parts 1 and 1 Expansion: Cmax of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Cmax was defined as the maximum observed concentration of itacitinib. |
| Secondary | Parts 1 and 1 Expansion: Ctau of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | Ctau was defined as the trough concentration of itacitinib over the dose interval. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28. |
| Secondary | Parts 1 and 1 Expansion: Tmax of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | tmax was defined as the time to the maximum concentration of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28. |
| Secondary | Parts 1 and 1 Expansion: Cl/F of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | Cl/F was defined as the apparent oral dose clearance of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28. |
| Secondary | Part 2: Cmax of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Cmax was defined as the maximum observed concentration of itacitinib. |
| Secondary | Part 2: Cmin of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Cmin was defined as the minimum observed plasma or serum concentration of itacitinib over the dose interval. |
| Secondary | Part 2: Tmax of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | tmax was defined as the time to the maximum concentration of itacitinib. |
| Secondary | Part 2: AUC0-t of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. |
| Secondary | Part 2: Cl/F of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Cl/F was defined as the apparent oral dose clearance of itacitinib. |
| Secondary | Part 1: Response Rate at Months 3, 6, and 12 | Months 3, 6, and 12 | Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs. |
| Secondary | Part 1 Expansion: Response Rate at Month 12 | Month 12 | Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs. |
| Secondary | Part 1 Expansion: Time to Response | up to Month 12 | Time to response was defined as the interval between randomization and the first response (CR or PR) before initiation of new therapy. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs. |
| Secondary | Part 1 Expansion: Duration of Response | up to 24 months | Duration to response was defined as the interval between the first response and cGVHD progression, death, or the initiation of a new systemic cGVHD therapy. |
| Secondary | Part 1 Expansion: Overall Survival | up to 36 months | Overall survival was defined as the interval between the date of randomization and the date of death due to any cause. |
| Secondary | Part 1 Expansion: Nonrelapse Mortality (NRM) Rate | up to 24 months | NRM was defined as the percentage of participants who died due to causes other than a relapse of their primary hematologic disease. |
| Secondary | Part 1 Expansion: Percentage of Participants With a ≥50% Reduction in Daily Corticosteroid Dose at Day 180 From the Corticosteroid Dose on Day 1 | Day 1; Day 180 | The corticosteroid dose at Day 180 was compared to the corticosteroid dose on Day 1 to assess reduction. |
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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