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A Study of PRT811 in Participants With Advanced Solid Tumors and Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089449
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Prelude Therapeutics

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 13, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE November 6, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • To describe dose limiting toxicities (DLT) of PRT811 [ Time Frame: Baseline through Day 21 ]
    Dose limiting toxicities will be evaluated through the first cycle
  • To determine the maximally tolerated dose (MTD) [ Time Frame: Baseline through approximately 2 years ]
    The MTD will be established for further investigation in participants with solid tumors and gliomas
  • To determine the recommended phase 2 dose (RP2D) and schedule of PRT811 [ Time Frame: Baseline through approximately 2 years ]
    The RP2D will be established for further investigation in participants with solid tumors and gliomas
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • To describe dose limiting toxicities (DLT) of PRT811 [ Time Frame: Baseline through Day 21 ]
    Dose limiting toxicities will be evaluated through the first cycle
  • To determine the maximally tolerated dose (MTD) [ Time Frame: Baseline through approximately 2 years ]
    The MTD will be established for further investigation in participants with solid tumors, gliomas and myelofibrosis
  • To determine the recommended phase 2 dose (RP2D) and schedule of PRT811 [ Time Frame: Baseline through approximately 2 years ]
    The RP2D will be established for further investigation in participants with solid tumors, gliomas and myelofibrosis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • To describe the adverse event profile and tolerability of PRT811 [ Time Frame: Baseline through approximately 2 years ]
    Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
  • To describe the pharmacokinetic profile of PRT811 [ Time Frame: Cycle 1 (each cycle is 21 days) on Days 1, 8 and 14. For subsequent cycles, Day 1 of each cycle through the end of study treatment, an average of 6 months ]
    PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration
  • To describe any anti-tumor activity of PRT811 [ Time Frame: Baseline through approximately 2 years ]
    Anti-tumor activity of PRT811 will be based on the measurement of objective responses
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PRT811 in Participants With Advanced Solid Tumors and Gliomas
Official Title  ICMJE A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors and Recurrent High-Grade Gliomas
Brief Summary This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.
Detailed Description This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or available treatment options including solid tumors and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors and/or high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors and glioblastoma multiforme. For subjects, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT811.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • Recurrent Glioma
Intervention  ICMJE Drug: PRT811
PRT811 will be administered orally
Study Arms  ICMJE Experimental: PRT811
PRT811 will be administered orally
Intervention: Drug: PRT811
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies
  • Biomarker-selected solid tumors
  • For subjects with recurrent high-grade glioma or GBM, must have biopsy proven evidence (WHO Grade III or IV) and received external bean fractionated radiotherapy and at least 2 cycles of adjuvant temozolomide chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Female subjects of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial

Exclusion Criteria:

  • Untreated concurrent malignancies or malignancies that have been in complete remission for less than one year
  • Treatment with strong inhibitors of CYP3A4 for which there are no therapeutic substitutions
  • Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption
  • HIV positive; known active hepatitis B or C
  • Known hypersensitivity to any of the components of PRT811
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04089449
Other Study ID Numbers  ICMJE PRT811-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prelude Therapeutics
Study Sponsor  ICMJE Prelude Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Prelude Therapeutics
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP