Trial · NCT02401048
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b/2 : Overall Response Rate of Number of Participants | From the date of first study treatment until progressive disease | The response criteria is measured based on the revised criteria for malignant lymphoma described by the International Working Group for NHL (Cheson 2014). |
| 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. | |
| Secondary | Phase 1b/ 2: Progression-free Survival (PFS) | first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression | |
| Secondary | Phase 1b/2: Overall Survival | First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause | |
| 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) | Maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| 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) | Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| 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) | Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| 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) | Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736 | Cycle 6 Day 1 (collected 10 minutes after end of infusion) | Peak plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736 | Cycle 6 Day 1 (predose) | Trough plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: MEDI4736 Accumulation Ratio for Cmax | Cycle 6 Day 1 (collected 10 minutes after end of infusion) | Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Cmax for MEDI4736 |
| Secondary | Pharmacokinetics: MEDI4736 Accumulation Ratio for Ctrough | Cycle 6 Day 1 (predose) | Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Ctrough for MEDI4736 |
| Secondary | Bruton Tyrosine Kinase (BTK) Occupancy | ibrutinib Lead-in Day 6 or 7 pre-dose | BTK occupancy |
| Secondary | Pharmacodynamics of Ibrutinib in Subjects With Relapsed or Refractory Lymphomas | Cycle 3 Day 1 Pre-dose | BTK occupancy |
| Secondary | Pharmacodynamics of MEDI4736 in Subjects With Relapsed or Refractory Lymphomas | Cycle 3 Day1 Pre-dose | Detectable Free Serum PD-L1 level |
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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