Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal and Genitourinary Tumors
Verified date | September 2022 |
Source | Pharmacyclics LLC. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advance gastrointestinal and genitourinary tumors.
Status | Completed |
Enrollment | 263 |
Est. completion date | August 20, 2021 |
Est. primary completion date | August 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: RCC (clear cell), urothelial carcinoma (UC) (transitional cell), gastric or gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR expressing CRC For cohort 1 RCC: minimum of 1 and maximum of 4 prior regimens, one or more of which must have included a VEGF-TKI For UC cohort 2: minimum of 1 and maximum of 2 prior regimens, one of which must have included a platinum-based regimen For UC cohort 5: Minimum of 1 and maximum of 2 prior regimens, one of which must have included a checkpoint inhibitor. For UC cohort 6: Locally advanced or mUC who are not eligible for cisplatin chemo with a PDL-1 score (CPS) of = 10 without prior treatment. Locally advanced or mUC who have progressed on platinum chemo or within 12 months of neo- or adjuvant therapy with a platinum chemotherapy. A minimum of 1 and maximum of 2 prior therapies. For cohort 3 gastric or GEJ adenocarcinoma: minimum of 1 and maximum of 3 prior regimens one of which must have included a fluoropyrimidine regimen For cohort 4 CRC: minimum of 2 and maximum of 4 prior regimens, which must have included both an irinotecan and an oxaliplatin based regimen unless unable to tolerate irinotecan chemotherapy Laboratory: Adequate hematologic function: Absolute neutrophil count =1500 cells/mm3 (1.5 x 109/L) Platelet count >80,000 cells/mm3 (80 x 109/L) for cohort 1 (RCC) Platelet counts >100,000 cells/mm3 (100 x 109/L) for all UC cohorts Hemoglobin =8.0 g/dL. for cohort 1 (RCC),all UC cohorts, and cohort 3 (GC) Hemoglobin =9.0 g/dL for cohort 4 (CRC) Adequate hepatic and renal function defined as: Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =5.0 x upper limit of normal (ULN) if liver metastases, or =3 x ULN without liver metastases Alkaline phosphatase <3.0 x ULN or =5.0 x ULN if liver or bone metastases present Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis) with the exception of subjects in the GC cohort where docetaxel is administered, these subjects must have bilirubin within normal limits (WNL) Estimated Creatinine Clearance =30 mL/min (Cockcroft-Gault) Exclusion Criteria Prior treatment with: Everolimus or temsirolimus (RCC cohort 1) Any taxane (UC cohort of ibrutinib + paclitaxel) (cohort 2) Checkpoint inhibitors (UC cohort 6) Any taxane (GC cohort 3) Cetuximab or panitumumab (CRC cohort 4) For all Cohorts: Concomitant use of warfarin or other Vitamin K antagonists History of stroke or intracranial hemorrhage within 6 months prior to enrollment Major surgery within 4 weeks of first dose of study drug Requires treatment with strong CYP3A inhibitors known bleeding disorders or hemophilia UC cohort 6 only: Subjects who have an active, known or suspected autoimmune disease. Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis. Non-steroid immunosuppressive medications within 14 days before the first dose of ibrutinib and pembrolizumab. Subjects in whom prior anti PD-1 / anti-PD-L1 therapy was intolerable and required discontinuation of treatment. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hwasun Hospital /ID# 1128-0916 | Jeonnam | |
Korea, Republic of | Seoul National University Bundang Hospital /ID# 1128-0982 | Seongnam | Gyeonggido |
Korea, Republic of | Asan Medical Center /ID# 1128-0963 | Seoul | |
Korea, Republic of | Korea University Guro Hospital /ID# 1128-0924 | Seoul | |
Korea, Republic of | Samsung Medical Center /ID# 1128-0925 | Seoul | |
Korea, Republic of | Seoul National University Hospital /ID# 1128-0926 | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 1128-0928 | Seoul | |
Korea, Republic of | Yonsei University Health System Severance Hospital /ID# 1128-0927 | Seoul | Seoul Teugbyeolsi |
Spain | Instituto Catalan de Oncologia (ICO) Badalona /ID# 1128-0984 | Badalona | Barcelona |
Spain | Hospital Clinic de Barcelona /ID# 1128-0533 | Barcelona | |
Spain | Hospital Universitario Vall d'Hebron /ID# 1128-0534 | Barcelona | |
Spain | Hospital Universitario 12 de Octubre /ID# 1128-0864 | Madrid | |
Spain | Hospital Universitario La Paz /ID# 1128-0921 | Madrid | |
Spain | Hospital Universitario Ramon y Cajal /ID# 1128-0874 | Madrid | |
Spain | Hospital Unversitario Marques de Valdecilla /ID# 1128-0973 | Santander | Cantabria |
Spain | Hospital Universitario Virgen del Rocio /ID# 1128-0863 | Sevilla | |
United Kingdom | Duplicate_Beatson west of scotland cancer center /ID# 1128-0652 | Glasgow | Scotland |
United Kingdom | Sarah Cannon Research Institute /ID# 1128-1079 | London | England |
United Kingdom | The Royal Marsden NHS Foundation Trust /ID# 1128-0543 | London | |
United Kingdom | The Christie Hospital /ID# 1128-0030 | Manchester | |
United Kingdom | Duplicate_Oxford University Hospitals NHS Trust /ID# 1128-0814 | Oxford | |
United States | Duplicate_New Mexico Cancer Care Alliance /ID# 1128-0938 | Albuquerque | New Mexico |
United States | Alta Bates Comprehensive Cancer Center /ID# 1128-0135 | Berkeley | California |
United States | Central Care Cancer Center /ID# 1128-1596 | Bolivar | Missouri |
United States | Duplicate_Tufts Medical Center /ID# 1128-0016 | Boston | Massachusetts |
United States | New Jersey Center for Cancer Research /ID# 1128-0493 | Brick | New Jersey |
United States | IACT Health-Columbus /ID# 1128-1389 | Columbus | Georgia |
United States | St Marys Medical Center /ID# 1128-0969 | Daly City | California |
United States | Barbara Ann Karmanos Cancer In /ID# 1128-0130 | Detroit | Michigan |
United States | Henry Ford Hospital /ID# 1128-0195 | Detroit | Michigan |
United States | Northshore Kellogg Cancer Center /ID# 1128-0484 | Evanston | Illinois |
United States | Duplicate_Virginia Cancer Specialists - Fairfax Office /ID# 1128-0972 | Fairfax | Virginia |
United States | The University of Kansas Cancer Center /ID# 1128-0706 | Fairway | Kansas |
United States | San Juan Oncology Associates /ID# 1128-1020 | Farmington | New Mexico |
United States | The University of Texas Medical Branch (UTMB) - Cancer Center - Galves /ID# 1128-0974 | Galveston | Texas |
United States | Banner MD Anderson Cancer Center /ID# 1128-0802 | Gilbert | Arizona |
United States | Penn State Hershey Medical Ctr /ID# 1128-0220 | Hershey | Pennsylvania |
United States | Clearview Cancer Institute /ID# 1128-0965 | Huntsville | Alabama |
United States | Franciscan Health Indianapolis /ID# 1128-1125 | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics /ID# 1128-0766 | Iowa City | Iowa |
United States | Duplicate_Cancer Specialist of North Florida (CSNF) ( R ) /ID# 1128-1093 | Jacksonville | Florida |
United States | Capital Region Medical Center /ID# 1128-1412 | Jefferson City | Missouri |
United States | Duplicate_University of California San Diego/ Moores Cancer Center /ID# 1128-0241 | La Jolla | California |
United States | Horizon Oncology Research Center /ID# 1128-0337 | Lafayette | Indiana |
United States | VA Long Beach Healthcare System /ID# 1128-0480 | Long Beach | California |
United States | USC Norris Cancer Center /ID# 1128-0209 | Los Angeles | California |
United States | East Jefferson General Hospital /ID# 1128-1084 | Metairie | Louisiana |
United States | Vanderbilt Infectious Disease Clinic /ID# 1128-0024 | Nashville | Tennessee |
United States | Memorial Sloan Kettering Cancer Center-Koch Center /ID# 1128-0091 | New York | New York |
United States | Whittingham Cancer Center at Norwalk Hospital /ID# 1128-0411 | Norwalk | Connecticut |
United States | Nebraska Methodist Hospital /ID# 1128-0229 | Omaha | Nebraska |
United States | UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1128-0008 | Orange | California |
United States | Abramson Cancer Center of the Univ. of Pennsylvania /ID# 1128-0402 | Philadelphia | Pennsylvania |
United States | Oregon Health & Science University /ID# 1128-0251 | Portland | Oregon |
United States | Gregory Smith, MD (Private Practice) /ID# 1128-0419 | Saint Helena | California |
United States | Salinas Valley Memorial Hosp /ID# 1128-0482 | Salinas | California |
United States | Premiere Oncology, A Medical Corporation /ID# 1128-1085 | Santa Monica | California |
United States | St. Joseph Health /ID# 1128-1462 | Santa Rosa | California |
United States | University of Washington /ID# 1128-1382 | Seattle | Washington |
United States | Virginia Mason Medical Center /ID# 1128-0005 | Seattle | Washington |
United States | Duplicate_Scott & White Mem Hosp & Clin /ID# 1128-0046 | Temple | Texas |
United States | University of Arizona Cancer Center - Tucson /ID# 1128-1546 | Tucson | Arizona |
United States | Georgetown University Hospital /ID# 1128-0824 | Washington | District of Columbia |
United States | Confluence Health /ID# 1128-0894 | Wenatchee | Washington |
United States | Wake Forest Univ HS /ID# 1128-0975 | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pharmacyclics LLC. |
United States, Korea, Republic of, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | A DLT was defined as any Grade 3 (severe) or higher non-hematologic or Grade 4 (life-threatening) hematologic adverse event (AE) occurring during the DLT observation period that was considered to be at least possibly related to the study treatment (ibrutinib or drug combination). | 21 days after the initiation of therapy at the start of Cycle 1 | |
Primary | Phase 1b/2 RP2D: Progression-Free Survival (PFS) as Assessed by Investigator in Cohorts 1 and 2 | PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of progressive disease (PD) or date of death from any cause, whichever occurs first, regardless of the use of subsequent anti-cancer treatment. PD was defined in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), and an absolute increase of = 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. | |
Primary | Phase 1b/2 RP2D: Overall Response Rate (ORR) as Assessed by Investigator in Cohorts 3 to 6 | ORR is defined as the percentage of participants who have a best response of partial response (PR) or complete response (CR) to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | |
Secondary | Phase 1b: ORR in Cohorts 1 to 6 | ORR is defined as the percentage of participants who have a best response of partial response (PR) or complete response (CR) to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | |
Secondary | Phase 1b: Disease Control Rate (DCR) in Cohorts 1 to 6 | DCR is is defined as the percentage of participants who have a best response of PR, CR, or stable disease (SD) to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after). For SD, tthere was no need for confirmation by a subsequent imaging assessment. | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | |
Secondary | Phase 1b/2 RP2D: DCR in Cohorts 1 to 6 | DCR is is defined as the percentage of participants who have a best response of PR, CR, or SD to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after). For SD, tthere was no need for confirmation by a subsequent imaging assessment. | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | |
Secondary | Phase 1b/2 RP2D: PFS in Cohorts 3 to 6 | PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or date of death from any cause, whichever occurs first, regardless of the use of subsequent anti-cancer treatment. PD was defined in accordance with RECIST 1.1 criteria. | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | |
Secondary | Phase 1b/2 RP2D: ORR in Cohorts 1 and 2 | ORR is defined as the percentage of participants who have a best response to therapy of PR or CR in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. (Reverse Kaplan-Meier estimates) | |
Secondary | Phase 1b/2 RP2D: Overall Survival (OS) in Cohorts 1 to 6 | OS is defined as the time from the date of first dose of study treatment to the date of death from any cause. Subjects who were not known to have died at the data extraction will be censored at date last known alive. | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | |
Secondary | Phase 1b/2 RP2D: Duration of Response (DOR) in Cohorts 1 to 6 | DOR is defined for confirmed responders (PR or better) as time from the date of initial response (PR or better) to the date of first documentation of PD (according to RECIST 1.1) or death, whichever occurs first, regardless of use of subsequent anti-cancer treatment. Confirmed responders without documentation of PD or death or with unknown status at the data extraction were censored at the last adequate post-baseline disease assessment showing no evidence of PD. PD was defined as at least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. |
Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | |
Secondary | Phase 1b: Observed Maximum Concentration (Cmax) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. The Cmax was noted as observed. | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | |
Secondary | Phase 1b: Time to Cmax (Tmax) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. The tmax was noted as observed. | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | |
Secondary | Phase 1b: Time of Last Observed Concentration (Tlast) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. The tlast was noted as observed. | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | |
Secondary | Phase 1b: Area Under the Concentration-Time Curve From Time 0 to Hour 24 (AUC0-24h) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. The AUC0-24h was calculated by the linear trapezoidal method. | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | |
Secondary | Phase 1b: Area Under the Concentration-Time Curve to Last Observed Time Point (AUClast) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. The AUClast was calculated by the linear trapezoidal method. | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | |
Secondary | Phase 1b: Terminal Elimination Half-Life (t1/2term) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. The apparent t1/2term was calculated by ln(2)/?z, where ?z is the apparent elimination rate constant obtained by linear regression of three or more log-transformed data points in the terminal phase (not including Cmax). | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | |
Secondary | Phase 1b: Terminal Elimination Rate Constant (?z) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. The ?z is the apparent elimination rate constant obtained by linear regression of three or more log-transformed data points in the terminal phase (not including Cmax). | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | |
Secondary | Phase 1b: Apparent Total Clearance at Steady-State (CLss/F) for Ibrutinib in Cohorts 1 to 4 | Actual collection times relative to ibrutinib administration were used for the calculation of pharmacokinetic parameters of ibrutinib and PCI-45227. For actual predose collection times that were < 0, these values were set equal to 0. Predose concentrations were applied as 24 hour concentrations in order to calculate steady-state (Cycle 2 Day 1) pharmacokinetic parameters for ibrutinib and PCI-45227. Apparent total CLss/F (Cycle 2 Day 1) was calculated as dose/AUC0-24h. | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose |
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