Trial · NCT02401048
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b/2 : Overall Response Rate of Number of Participants | From the date of first study treatment until progressive disease | While the study include Phase 1b and 2, the dosing was not changed between phases (following the study design because there were no DLTs and thus no dose adjustments in from Phase 1b to Phase 2). Thus the study data were reported with Phases 1b and 2 combined. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1b/ 2: Duration of Response | Time from the date of initial response to the date of disease progression or the date of death due to any cause, whichever occurs first. | Months | MEDIAN | |
| SECONDARY | Phase 1b/ 2: Progression-free Survival (PFS) | first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression | Months | MEDIAN | |
| SECONDARY | Phase 1b/2: Overall Survival | First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause | Months | MEDIAN | |
| SECONDARY | Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | hour | MEDIAN |
| SECONDARY | Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | ng*h/mL | MEAN |
| SECONDARY | Pharmacokinetics: Mean Terminal Elimination Half-Life (t1/2,Term) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | hour | MEAN |
| SECONDARY | Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736 | Cycle 6 Day 1 (collected 10 minutes after end of infusion) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736 | Cycle 6 Day 1 (predose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: MEDI4736 Accumulation Ratio for Cmax | Cycle 6 Day 1 (collected 10 minutes after end of infusion) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | ratio | MEAN |
| SECONDARY | Pharmacokinetics: MEDI4736 Accumulation Ratio for Ctrough | Cycle 6 Day 1 (predose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | ratio | MEAN |
| SECONDARY | Bruton Tyrosine Kinase (BTK) Occupancy | ibrutinib Lead-in Day 6 or 7 pre-dose | All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data. | BTK % occupancy | MEAN |
| SECONDARY | Pharmacodynamics of Ibrutinib in Subjects With Relapsed or Refractory Lymphomas | Cycle 3 Day 1 Pre-dose | All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data. | BTK % occupancy | MEAN |
| SECONDARY | Pharmacodynamics of MEDI4736 in Subjects With Relapsed or Refractory Lymphomas | Cycle 3 Day1 Pre-dose | In Follicular lymphoma expansion cohort, 7 subjects are below limit of quantitation. In Diffuse large B-cell lymphoma expansion cohort, all subjects below limit of quantitation. | pg/mL | NUMBER |
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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