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| ID | Type | Description | Link |
|---|---|---|---|
| EZH2 | Other Identifier | Alias Study Number | |
| 2023-509179-18-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.
Part 3, which is open for enrollment is seeking men who:
All participants in Part 3 of this study will receive mevrometostat and/ or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).
In the assessment phase:
After completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.
The study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.
This is an open label, multi center, Phase 1 dose escalation and dose expansion study of mevrometostat (PF-06821497) administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. The study consists of three parts (Part 1, Part 2, and Part 3) along with the Japan and China monotherapy cohorts. Part 1 and Part 2 are closed for enrollment. Part 1 tested monotherapy in 3 cohorts (Parts 1A, 1B, and 1C); Part 2 tested combination therapy in Parts 2A (dose escalation), 2B and 2C (does expansion).
Part 3 consists of the Bioequivalence (BE) and drug-drug interaction (DDI) substudies and are open for enrollment. The BE substudy will test between 2 mevrometostat formulation to confirm that they work in the body the same way. The DDI substudy will evaluate the effect of a strong CYP3A4 (an enzyme in your body that breaks down/ removes drugs) inhibitor on the PK of mevrometostat; a strong CYP3A4 inhibitor may slow down the breakdown/ removal of drugs in your body. The Sponsor may choose to delay or discontinue any cohorts or substudies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation (Part 1A) | Experimental | Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels |
|
| Dose Escalation (Part 1B) | Experimental | Participants with FL will receive mevrometostat at escalating dose levels |
|
| Dose Escalation (Part 1C) | Experimental | Participants with mCRPC will receive mevrometostat at escalating dose levels. |
|
| Dose Escalation (Part 2A) | Experimental | Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC. |
|
| Dose Expansion (Part 2B) | Experimental | Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mervometostat (PF-06821497) | Drug | Oral continuous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) | First cycle DLTs will be utilized to determine the MTD | Baseline up to 90 days |
| Overall safety profile including adverse events | Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [4.03]) | Baseline up to approximately 2 years |
| Preliminary efficacy determination as evaluated by disease specific response criteria | Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC. | Through study completion, approximately 2 years past last patient first visit. |
| Overall safety profile including laboratory abnormalities | Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version [4.03]), and timing. | Baseline up to approximately 2 years |
| Overall safety profile including vital signs | Vital sign changes from baseline including blood pressure, heart rate, ECG changes. | Baseline up to approximately 2 years |
| Evaluate time to event mevrometostat and enzalutamide vs enzalutamide alone including radiographic prgression free survival | PCWG3 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate time to event anti-tumor activity of mevrometostat including progression-free survival (PFS), PSA50, Duration of Response (DoR), Time to first skeletal related event and Time to symptomatic skeletal related event, depending on tumor type. | Time to event endpoints based on Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC) |
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Part 1 and Part 2 (Closed for enrollment).
Part 3 Key Inclusion Criteria:
Part 3 Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner-University Medical Center Tucson | Active, not recruiting | Tucson | Arizona | 85719 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Japan Cohort |
| Experimental |
Participants with CRPC will receive mevrometostat at one or two doses |
|
| China cohort | Experimental | Participants will receive mevrometostat at one or two doses |
|
| Dose Expansion (Part 2C) | Experimental | Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC |
|
| BE Substudy | Experimental | In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
|
| DDI Substudy | Experimental | The DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
|
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| Enzalutamide | Drug | Oral continuous |
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| Itraconazole | Drug | Oral solution |
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| Baseline until disease progression or death or through study completion (approx 2 years) |
| Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years. |
| Evaluate overall survival | Median time to death proportion of patients alive at 6 months, 1 year, and 2 years. | Baseline up to approximately 2 years |
| Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) | Single dose and multiple dose PK will be calculated as data permits | At specific timepoints from Cycle 1 day 1 to End of Treatment visit |
| Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax) | Single dose and multiple dose PK will be calculated as data permits | At specific timepoints from Cycle 1 day 1 to End of Treatment visit |
| Pharmacokinetic Parameters: Area Under the Curve (AUC) | Single dose and multiple dose PK will be calculated as data permits | At specific timepoints from Cycle 1 day 1 to End of Treatment visit |
| Pharmacokinetic Parameters: Apparent Oral Clearance (CL/F) | Single dose and multiple dose PK will be calculated as data permits | At specific timepoints from Cycle 1 day 1 to End of Treatment visit |
| Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F) | Single dose and multiple dose PK will be calculated as data permits | At specific timepoints from Cycle 1 day 1 to End of Treatment visit |
| Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2) | Singe dose and multiple dose PK will be calculated as data permits | At specific timepoints from Cycle 1 day 1 to End of Treatment visit |
| Evaluate the impact of mevrometostat on patient reported outcomes. | Quality of Life and Time to Functional Status Deterioration as assessed by FACT-P. | At specific time-points from Cycle 1 Day 1 to End of Treatment visit. |
| Impact of mevrometostat in combination with enzalutamide, enzalutamide alone and mevrometostat alone on symptoms and symptomatic toxicity | Questionnaire customized from PRO-CTCAE. | At specific time points from Cycle1 Day 1 to end of treatment |
| The University of Arizona Cancer Center-North Campus |
| Active, not recruiting |
| Tucson |
| Arizona |
| 85719 |
| United States |
| The University of Arizona Cancer Center | Active, not recruiting | Tucson | Arizona | 85724 | United States |
| Arizona Urology Specialists, PLLC | Terminated | Tucson | Arizona | 85741 | United States |
| Pacific Cancer Medical Center INC | Active, not recruiting | Anaheim | California | 92801 | United States |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Active, not recruiting | Duarte | California | 91010 | United States |
| City of Hope Investigational Drug Services (IDS) | Active, not recruiting | Duarte | California | 91010 | United States |
| Norwalk Hospital | Active, not recruiting | Norwalk | Connecticut | 06856 | United States |
| The University of Kansas Cancer Center, Investigational Drug Services | Active, not recruiting | Fairway | Kansas | 66205 | United States |
| The University of Kansas Clinical Research Center | Active, not recruiting | Fairway | Kansas | 66205 | United States |
| The University of Kansas Hospital | Active, not recruiting | Kansas City | Kansas | 66160 | United States |
| The University of Kansas Medical Center Medical Office Building | Active, not recruiting | Kansas City | Kansas | 66160 | United States |
| The University of Kansas Cancer Center - Indian Creek Campus | Active, not recruiting | Overland Park | Kansas | 66211 | United States |
| The University of Kansas Cancer Center | Active, not recruiting | Westwood | Kansas | 66205 | United States |
| Norton Cancer Institute - Downtown | Active, not recruiting | Louisville | Kentucky | 40202 | United States |
| Norton Cancer Institute Pharmacy, Downtown Pharmacy | Active, not recruiting | Louisville | Kentucky | 40202 | United States |
| Norton Cancer Institute Pharmacy | Active, not recruiting | Louisville | Kentucky | 40202 | United States |
| Norton Cancer Institute, Norton Healthcare Pavilion | Active, not recruiting | Louisville | Kentucky | 40202 | United States |
| Norton Hospital | Active, not recruiting | Louisville | Kentucky | 40202 | United States |
| Maryland Oncology Hematology, P.A. | Terminated | Rockville | Maryland | 20850 | United States |
| Brigham and Women's Hospital | Active, not recruiting | Boston | Massachusetts | 02115 | United States |
| Dana Farber Cancer Institute | Active, not recruiting | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute- Chestnut Hill | Active, not recruiting | Newton | Massachusetts | 02459 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
| Hackensack University Medical Center | Active, not recruiting | Hackensack | New Jersey | 07601 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Active, not recruiting | Hackensack | New Jersey | 07601 | United States |
| OU Health University of Oklahoma Medical Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Stephenson Cancer Center (chemo location) | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Carolina Urologic Research Center | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
| Parkway Surgery Center | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
| Sarah Cannon Research Institute - Pharmacy | Recruiting | Nashville | Tennessee | 37203 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - Austin Midtown | Terminated | Austin | Texas | 78705 | United States |
| University of Texas Southwestern Medical Center - Simmons Cancer Center | Active, not recruiting | Dallas | Texas | 75390 | United States |
| UT Southwestern Medical Center | Active, not recruiting | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital - William P. Clements, Jr | Active, not recruiting | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital - Zale Lipshy | Active, not recruiting | Dallas | Texas | 75390 | United States |
| NEXT Dallas | Not yet recruiting | Irving | Texas | 75039 | United States |
| US Oncology Investigational Product Center (IPC) | Terminated | Irving | Texas | 75063 | United States |
| US Oncology Investigational Products Center | Terminated | Irving | Texas | 75063 | United States |
| NEXT Oncology | Active, not recruiting | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists, PC | Active, not recruiting | Fairfax | Virginia | 22031 | United States |
| Olympic Medical Center | Active, not recruiting | Port Angeles | Washington | 98362 | United States |
| Fred Hutchinson Cancer Center Alliance Peninsula | Active, not recruiting | Poulsbo | Washington | 98370 | United States |
| Fred Hutchinson Cancer Center | Active, not recruiting | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Active, not recruiting | Seattle | Washington | 98195 | United States |
| Specialized Hospital for Active Treatment of Oncology - Haskovo | Terminated | Haskovo | 6300 | Bulgaria |
| The First Affiliated Hospital of Guangzhou Medical University | Active, not recruiting | Guangzhou | Guangdong | 510120 | China |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Active, not recruiting | Wenzhou | Zhejiang | 325000 | China |
| National Cancer Center Hospital East | Active, not recruiting | Kashiwa | Chiba | 277-8577 | Japan |
| Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie | Active, not recruiting | Koszalin | 75-581 | Poland |
| Centrum Medyczne MEDYK | Active, not recruiting | Rzeszów | 35-326 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie | Active, not recruiting | Warsaw | 02-781 | Poland |
| Private Medical Institution "Euromedservice" | Active, not recruiting | Pushkin | Sankt-Peterburg | 196603 | Russia |
| LLC "Neyro-klinika" | Active, not recruiting | Moscow | 117186 | Russia |
| Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department | Terminated | Moscow | 125284 | Russia |
| SBHI of Moscow City Clinical Hospital | Terminated | Moscow | 129301 | Russia |
| Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary" | Terminated | Omsk | 644013 | Russia |
| Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov | Terminated | Saint Petersburg | 197341 | Russia |
| Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N. | Terminated | Saint Petersburg | 197758 | Russia |
| Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary" | Terminated | Saint Petersburg | 198255 | Russia |
| State Budgetary Healthcare Institution of the Yaroslavl Region | Terminated | Yaroslavl | 150054 | Russia |
| Seoul National University Bundang Hospital | Recruiting | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Seoul National University Hospital | Active, not recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Active, not recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03722 | South Korea |
| Ewha Womans University Mokdong Hospital | Active, not recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 07985 | South Korea |
| Chungnam national university hospital | Active, not recruiting | Daejeon | Taejǒn-kwangyǒkshi | 35015 | South Korea |
| Institut Català d´Oncología (ICO)-H. Durán i Reynals | Recruiting | L'Hospitalet de Llobregat | Barecelona | 08908 | Spain |
| Consorcio Hospitalario Provincial de Castellon | Active, not recruiting | Castellon | Castellon | 12002 | Spain |
| Hospital Quironsalud Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Quironsalud Barcelona | Recruiting | Barcelona | 08023 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| H.U. Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario 12 De Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitari i Politecnic La Fe | Active, not recruiting | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D008224 | Lymphoma, Follicular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000710328 | PF06821497 |
| C540278 | enzalutamide |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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