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A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT03886831
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Prelude Therapeutics

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 22, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE February 11, 2019
Estimated Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • To describe dose limiting toxicities (DLT) of PRT543 [ Time Frame: Baseline through Day 28. ]
    Dose limiting toxicities (DLTs) will be evaluated during the first cycle
  • To determine the maximally tolerated dose (MTD) [ Time Frame: Baseline through approximately 2 years. ]
    The maximum tolerated dose (MTD) will be established for further investigation in participants with advanced malignancies who have failed prior treatments.
  • To determine the recommended phase 2 dose (RP2D) and schedule of PRT543 [ Time Frame: Baseline through approximately 2 years. ]
    The recommended phase 2 dose (RP2D) and optimal dosing schedule of PRT543 will be established for further investigation in participants with advanced malignancies who have failed prior treatments.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2020)
  • To describe the adverse event profile and tolerability of PRT543 [ Time Frame: Baseline through approximately 2 years ]
    Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
  • To determine the maximum observed plasma concentration (Cmax) of PRT543 [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including the maximum observed plasma concentration.
  • To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543 [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including the time to reach maximum observed plasma concentration
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • To describe the adverse event profile and tolerability of PRT543 [ Time Frame: Baseline through approximately 2 years ]
    Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
  • To determine the maximum observed plasma concentration (Cmax) of PRT543 [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1 and 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 4, 8, 11, 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including the maximum observed plasma concentration.
  • To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543 [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1 and 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 4, 8, 11, 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including the time to reach maximum observed plasma concentration
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2020)
  • To determine the terminal elimination half-life (t1/2) of PRT543. [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including the terminal elimination half life
  • To determine the area under the plasma concentration versus time curve (AUC) of PRT543 [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including area under the plasma concentration versus time curve.
Original Other Pre-specified Outcome Measures
 (submitted: March 21, 2019)
  • To determine the terminal elimination half-life (t1/2) of PRT543. [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1 and 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 4, 8, 11, 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including the terminal elimination half life
  • To determine the area under the plasma concentration versus time curve (AUC) of PRT543 [ Time Frame: Cycle 1 (each cycle is 28 days) on Days 1 and 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 4, 8, 11, 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1. ]
    PRT543 pharmacokinetics will be calculated including area under the plasma concentration versus time curve.
 
Descriptive Information
Brief Title  ICMJE A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies
Official Title  ICMJE A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies
Brief Summary This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers 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 PRT543.
Detailed Description This is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options. Enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and one for hematological malignancies). The study will consist of 2 parts, a dose escalation part, and once the recommended phase 2 dose (RP2D) has been determined, a cohort expansion part involving up to nine separate cohorts. For patients, 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 PRT543.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed/Refractory Advanced Solid Tumors
  • Relapsed/Refractory Diffuse Large B-cell Lymphoma
  • Relapsed/Refractory Myelodysplasia
  • Relapsed/Refractory Myelofibrosis
  • Adenoid Cystic Carcinoma
  • Relapsed/Refractory Mantle Cell Lymphoma
  • Relapsed/Refractory Acute Myeloid Leukemia
  • Refractory Chronic Myelomonocytic Leukemia
Intervention  ICMJE Drug: PRT543
PRT543 will be administered orally
Study Arms  ICMJE Experimental: PRT543
PRT543 will be administered orally
Intervention: Drug: PRT543
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: February 3, 2021)
227
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
100
Estimated Study Completion Date  ICMJE August 11, 2022
Estimated Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to established therapies
  • Biomarker-selected solid tumors
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Female patients 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:

  • Primary malignancies of the Central Nervous System(CNS) or uncontrolled CNS metastases
  • Requirement of pharmacologic doses of glucocorticoids
  • Prior treatment with chimeric antigen receptor T cells (CAR-T cells)
  • HIV positive; known active hepatitis B or C
  • Known hypersensitivity to any of the components of PRT543
  • Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less than 100 days since transplantation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 615-329-7274 CANN.REFMAL605@SarahCannon.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03886831
Other Study ID Numbers  ICMJE PRT543-01
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 March 2021

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