Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Epithelioid Sarcoma

Tazemetostat

Ipsen Medical Director

A multicenter, open-label expanded access program to provide access to tazemetostat to Epithelioid Sarcoma (ES) patients in serious need who are otherwise unable to participate in a clinical study or whom access is not available through marketed product in the US.

Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma

Epizyme, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Small Cell Lung Carcinoma

Prostatic Neoplasms

Lung Neoplasms

Lymphoma

Lymphoma, Follicular

Carcinoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Lymphoma, Non-Hodgkin

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Lymphosarcoma

Follicular Lymphoma

Participants with SCLC, CRPC and FL will receive PF-06821497 at escalating dose levels

Participants with FL will receive PF-06821497 at escalating dose levels

Participants with CRPC will receive PF-06821497 at escalating dose levels.

Participants with CRPC and SCLC will receive PF-06821497 at escalating dose levels in combination with SOC.

Participants with CRPC will receive PF-06821497 in combination with SOC or SOC alone.

Participants with CRPC will receive PF-06821497 at one or two doses

Participants will receive PF-06821497 at one or two doses

PF-06821497

Pfizer CT.gov Call Center

A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of PF-06821497 administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. Part 1A will evaluate safety and target modulation of PF-06821497 monotherapy in patients with SCLC, FL and CRPC. PF-06821497 will be administered as monotherapy in patients with FL in Part 1B dose escalation and to patients with CRPC in Part 1C dose escalation. For Part 2A (dose escalation combination therapy), PF-06821497 will be administered in combination with SOC in patients with CRPC and SCLC. For Part 2B (dose expansion), patients with mCRPC will be randomized (1:1 ratio) to receive either SOC or PF-06821497 in combination with SOC. Once safety and adequate target modulation has been established in Part 1A, Parts 1B and 2A of the trial will be initiated. Part 1C (monotherapy dose escalation) will determine the MTD of single agent PF-06821497 in patients with mCRPC. Japan and China monotherapy cohorts will evaluate the safety, antitumor activity and PK of single agent PF-06821497 in Japanese and Chinese patients. Part 2A (escalation RP2D finding for combination) will determine the MTD of the combination with SOC in patients with CRPC. Part 2B (dose expansion) will assess the efficacy of PF-06821497 at the RP2D in combination with SOC in patients with mCRPC in comparison to SOC alone. The study is currently enrolling Part 2B.

PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

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.

First cycle DLTs will be utilized to determine the MTD

Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[4.03\])

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.

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version \[4.03\]), and timing.

Vital sign changes from baseline including blood pressure, heart rate, ECG changes.

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)

Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.

Single dose and multiple dose PK will be calculated as data permits

Singe dose and multiple dose PK will be calculated as data permits

Quality of Life and Time to Functional Status Deterioration as assessed by FACT-P.

Pfizer

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Phase 1:

90 mg/m\^2 of bendamustine by IV on Day 1 and 2 of a 28 day cycle (up to 3 Cycles)

375 mg/m\^2 of rituximab by IV on Day 1 of a 28 day cycle (up to 3 Cycles)

Participants enrolled in this phase will be given one of 3 different dose levels of tazemetostat along with the drugs above (for up to 3 Cycles). 3 patients will be assigned to the lowest dose level and if the dose is tolerated, 3 more patients will be enrolled one dose level higher. Up to 18 participants being enrolled.

Dose Level 1: 400 mg of tazemetostat orally twice daily

Dose Level 2: 600 mg of tazemetostat orally twice daily

Dose Level 3: 800 mg of tazemetostat orally twice daily

Phase 2:

6 patients from Phase 1 who were treated at the recommended Phase 2 dose will be added to 21 additional patients.

375 mg/m\^2 of rituximab through IV on Day 1 of a 28 day cycle (Cycles 1-6)

Tazemetostat orally twice daily of a 28 day cycle (Cycles 1-6)

Bendamustine

RP2D (400, 600, or 800 mg) orally twice daily Cycles 1-6

Vaishalee Kenkre, MD

Kimberly Cameron

Reem Karmali, MD

Kimberly Saulsberry

Carlos Galvez, MD

Kellie Harper

Andrew Evens, DO

Misty Fleming

Naren Epperla, MD

Jennifer Burken, MS

This study is planned as a single arm clinical trial of tazemetostat in combination with bendamustine and rituximab with both a phase I and phase II component. All patients will receive tazemetostat twice daily on days 1-28 in combination with bendamustine 90 mg/m2 IV on days 1 and 2 and rituximab 375 mg/m2 IV on day 1 of a 28-day cycle for up to three cycles. Following this, patients will receive tazemetostat twice daily on days 1-28 and rituximab 375 mg/m2 IV on day 1 of a 28-day cycle for up to three cycles.

A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma

A Single Arm Phase I/II Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma Big Ten Cancer Research Consortium BTCRC-LYM20-463

Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

CMR will include complete metabolic response as defined by the Lugano classification.

Estimate the ORR after 3 cycles of BR plus tazemetostat. ORR (defined as CMR + PMR) as determined by the Lugano classification.

Estimate the CMR rate after 3 cycles of BR plus tazemetostat. CMR rate will include complete metabolic response as defined by the Lugano classification.

Evaluate DOR. DOR defined as the interval from response initiation (when either CMR or PMR is first determined) to progression or death, whichever occurs first. Metabolic response is defined by the Lugano classification.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma	NCT04225429	Epithelioid Sar...	Tazemetostat	18 Years -	Ipsen
PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma	NCT03460977	Castration Resi... Small Cell Lung... Follicular Lymp...	PF-06821497	18 Years -	Pfizer
A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma	NCT05551936	Follicular Lymp...	Bendamustine Rituximab Tazemetostat	18 Years -	Big Ten Cancer Research Consortium
Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma	NCT04225429	Epithelioid Sar...	Tazemetostat	18 Years -	Ipsen
A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma	NCT05551936	Follicular Lymp...	Bendamustine Rituximab Tazemetostat	18 Years -	Big Ten Cancer Research Consortium

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Spots Global Cancer Trial Database for ezh2

Every month we try and update this database with for ezh2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ezh2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.