RECRUITING

A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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: * have Castration Resistant Prostate Cancer (CRPC) and * have previously received treatment for CRPC and have progressed from the last treatment 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. In the assessment phase: * participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods. * participants in the DDI substudy will take mevrometostat 2 times a day, with or without enzalutamide 1 time a day, and/or itraconazole 1 time a day based on a present schedule. 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 studywill look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.

Official Title

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

Quick Facts

Study Start:2018-04-17
Study Completion:2029-03-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03460977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histological or cytological diagnosis of castration resistant prostate cancer.
  2. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months.
  3. * Adequate bone marrow, renal, and liver function
  1. * Prior irradiation to \>25% of the bone marrow.
  2. * QTcF interval \>480 msec at screening.
  3. * Hypertension that cannot be controlled by medications (\>150/90 mmHg despite optimal medical therapy).
  4. * Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)
  5. * Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
  6. * Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4/5 inducers or inhibitors
  7. * Prior enzalutamide within the last 4 weeks
  8. * DDI SUBSTUDY:
  9. * history of CHF or evidence of ventricular dysfunction
  10. * fructose intolerance
  11. * coadministration of CYP3A4 substrates

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Banner-University Medical Center Tucson
Tucson, Arizona, 85719
United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
The University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
Arizona Urology Specialists, PLLC
Tucson, Arizona, 85741
United States
Pacific Cancer Medical Center INC
Anaheim, California, 92801
United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010
United States
Norwalk Hospital
Norwalk, Connecticut, 06856
United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, 66205
United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
United States
The University of Kansas Hospital
Kansas City, Kansas, 66160
United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, 66160
United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, 66211
United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky, 40202
United States
Norton Cancer Institute Pharmacy
Louisville, Kentucky, 40202
United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
Norton Hospital
Louisville, Kentucky, 40202
United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, 02459
United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
OU Health University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572
United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055
United States
Tennessee Oncology PLLC
Franklin, Tennessee, 37067
United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066
United States
Tenessee Oncology, PLLC
Hendersonville, Tennessee, 37075
United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076
United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37090
United States
Tennessee Oncology PLLC
Murfreesboro, Tennessee, 37129
United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
United States
Tennessee Oncolgy, PLLC
Nashville, Tennessee, 37203
United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
United States
Tennessee Oncology-PLLC
Nashville, Tennessee, 37203
United States
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205
United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37207
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211
United States
Tennessee Oncology, PLLC
Shelbyville, Tennessee, 37160
United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167
United States
Texas Oncology - Austin Midtown
Austin, Texas, 78705
United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75390
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas, 75390
United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, 75390
United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063
United States
US Oncology Investigational Products Center
Irving, Texas, 75063
United States
NEXT Oncology
San Antonio, Texas, 78240
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States
Olympic Medical Center
Port Angeles, Washington, 98362
United States
Fred Hutchinson Cancer Center Alliance Peninsula
Poulsbo, Washington, 98370
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
University of Washington Medical Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-17
Study Completion Date2029-03-14

Study Record Updates

Study Start Date2018-04-17
Study Completion Date2029-03-14

Terms related to this study

Keywords Provided by Researchers

  • EZH2
  • enhancer of zeste homolog 2
  • castrate resistant prostate cancer
  • prostatecancer-study.com
  • mCRPC
  • efficacy
  • safety
  • pharmacokinetics
  • pharmacodynamics
  • dose escalation
  • dose expansion
  • open-label
  • small cell lung cancer
  • SCLC
  • follicular lymphoma
  • FL
  • relapsed
  • refractory

Additional Relevant MeSH Terms

  • Metastatic Castration Resistant Prostate Cancer (mCRPC)
  • Small Cell Lung Cancer (SCLC)
  • Follicular Lymphoma (FL)