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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-MC-JZNZ | Other Identifier | Eli Lilly and Company |
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The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.
The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirtobrutinib Phase 1 | Experimental | Pirtobrutinib administered orally |
|
| Pirtobrutinib Phase 2 | Experimental | Pirtobrutinib administered orally |
|
| Placebo Phase 2 | Placebo Comparator | Placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1-Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline Up to Week 4 |
| Phase 1-Dose Limiting Toxicity (DLT) of Pirtobrutinib | DLTs of Pirtobrutinib | Baseline Up to Week 4 |
| Phase 1-Number of Participants with Treatment-Related Adverse Events as Assessed by Vital Signs: Blood Pressure, Pulse Rate, and Body Temperature | Blood Pressure, Pulse Rate, and Body Temperature | Baseline Up to Week 16 |
| Phase 1-Number of Participants with Treatment-Related Adverse Events as Assessed by Clinical Lab Tests: Hematology, Clinical Chemistry, Urinalysis, Pregnancy, Hepatitis Serology and Cytomegalovirus (CMV) | Hematology, Clinical Chemistry, Urinalysis, Pregnancy, Hepatitis Serology and Cytomegalovirus (CMV) | Baseline Up to Week 16 |
| Phase 1-Number of Participants with Treatment-Related Adverse Events as Assessed by Electrocardiograms (ECGs): ECG QT Interval | ECG QT Interval | Baseline Up to Week 16 |
| Phase 2-Efficacy of Pirtobrutinib Versus Placebo | Stable platelet response rate is defined as the proportion of participants achieving platelet count of greater than or equal to 50 thousand per microliter (k/μL) and on at least 4 of the 6 consecutive biweekly visits between weeks 14 and 24 in the absence of rescue therapy and prohibited concomitant medication that may impact efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1-Preliminary Efficacy of Pirtobrutinib | Platelet response rate defined as proportion of participants who achieve at least 2 consecutive platelet counts of greater than or equal to 50 k/μL and an increase from baseline of greater than or equal to 20 k/μL to any time during treatment without the use of rescue medication within 4 weeks prior to the latest elevated platelet count. | Day 1 Up to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States | |
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| Label | URL |
|---|---|
| Lilly Trials | View source |
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Phase 1-Open label Sequential, Phase 2-Double-blind Parallel
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Phase 1-Open label, Phase 2-Double-blind
| Placebo |
| Drug |
Administered orally |
|
| Baseline Up to Week 24 |
| Phase 1-Evaluate the Extent of Disease Control | Number of cumulative weeks with platelet counts greater than or equal to 50 k/μL by Week 12 | Day 1 Up to Week 12 |
| Phase 1: Pharmacokinetics (PK) of Pirtobrutinib | PK: Plasma Concentrations of Pirtobrutinib | Baseline Up to Week 16 |
| Phase 2-Assess Additional Efficacy of Pirtobrutinib Versus Placebo | Platelet response rate is defined as the proportion of participants with greater than or equal to 2 consecutive platelet counts greater than or equal to 50 k/μL and an increase of platelet count of greater than or equal to 20 k/μL from baseline to any time during treatment or follow-up without the use of rescue medication or prohibited concomitant medication that may impact efficacy within 4 weeks prior to the latest elevated platelet count | Week 14 Up to Week 24 |
| Phase 2-Evaluate the Extent of Disease Control of Pirtobrutinib Versus Placebo | Number of cumulative weeks with platelet counts greater than or equal to 50 k/μL | Baseline Up to Week 24 |
| Phase 2-Evalulate the Extent of Disease Control of Pirtobrutinib Versus Placebo | Number of cumulative weeks with platelet counts greater than or equal to 100 k/μL | Baseline Up to Week 24 |
| Phase 2-Describe the Use of Rescue Medications of Pirtobrutinib Versus Placebo | Proportion of participants requiring rescue therapy | Baseline Up to Week 24 |
| Phase 2-Describe the PK of Pirtobrutinib | PK: Plasma Concentrations of Pirtobrutinib | Week 16 Up to Week 40 |
| Stanford University |
| Not yet recruiting |
| Stanford |
| California |
| 94305-5406 |
| United States |
| MedStar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center | Not yet recruiting | Miami | Florida | 33136 | United States |
| Bleeding and Clotting Disorders Institute | Not yet recruiting | Peoria | Illinois | 61614 | United States |
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70121 | United States |
| Mayo Clinic | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| Clinical Research Alliance | Recruiting | Westbury | New York | 11590 | United States |
| Texas Oncology - Central South | Not yet recruiting | Austin | Texas | 78758 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Texas Oncology Gulf Coast | Not yet recruiting | The Woodlands | Texas | 77380 | United States |
| Nanfang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | 510515 | China |
| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | 250012 | China |
| Hematology Hospital of the Chinese Academy of Medical Sciences | Not yet recruiting | Tianjin | 300020 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Not yet recruiting | Wuhan | 430022 | China |
| OUH | Recruiting | Odense C | 5000 | Denmark |
| Hôpital Henri Mondor | Recruiting | Créteil | 94010 | France |
| CHU Dijon - Hopital du Bocage | Recruiting | Dijon | 21034 | France |
| CHU Bordeaux - HĂ´pital Haut-LĂ©vĂªque | Recruiting | Pessac | 33604 | France |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS | Recruiting | Bologna | 40138 | Italy |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) | Not yet recruiting | Trieste | 34129 | Italy |
| Haukeland University Hospital | Not yet recruiting | Bergen | 5021 | Norway |
| Sykehuset Ostfold, Kalnes | Not yet recruiting | GrĂ¥lum | 1714 | Norway |
| St. Olavs Hospital Hf, Universitetssykehuset i Trondheim | Not yet recruiting | Trondheim | 7030 | Norway |
| Pratia Onkologia Katowice | Recruiting | Katowice | 40-519 | Poland |
| Pratia MCM Krakow | Recruiting | Krakow | 30-727 | Poland |
| Aidport sp z o.o. | Recruiting | Skorzewo | 60-185 | Poland |
| MICS Centrum Medyczne Torun | Recruiting | Torun | 87-100 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Not yet recruiting | Wroclaw | 50-367 | Poland |
| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario de Burgos | Recruiting | Burgos | 09006 | Spain |
| Hospital General Universitario Morales Meseguer | Recruiting | Murcia | 30008 | Spain |
| Clinica Universidad de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Bristol Haematology and Oncology Centre | Recruiting | Bristol | BS2 8ED | United Kingdom |
| St James's University Hospital | Recruiting | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Recruiting | Leicester | LE1 5WW | United Kingdom |
| Royal London Hospital | Not yet recruiting | London | E1 1FR | United Kingdom |
| Hammersmith Hospital | Not yet recruiting | London | W12 0HS | United Kingdom |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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