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A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies

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: NCT04543305
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Prelude Therapeutics

Tracking Information
First Submitted Date  ICMJE September 2, 2020
First Posted Date  ICMJE September 10, 2020
Last Update Posted Date December 8, 2020
Actual Study Start Date  ICMJE September 28, 2020
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2020)
  • To describe dose limiting toxicities (DLT) of PRT1419 [ Time Frame: Baseline through Day 28 ]
    Dose limiting toxicities will be evaluated through the first cycle
  • To determine the maximally tolerated dose (MTD) and/or optimal biological dose (OBD) [ Time Frame: Baseline through approximately 2 years ]
    The MTD and/or OBD will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome
  • To determine the recommended phase 2 dose (RP2D) and schedule of PRT1419 [ Time Frame: Baseline through approximately 2 years ]
    The RP2D will be established for further investigation in participants with multiple myeloma, Non-Hodgkin's Lymphoma, acute myeloid leukemia and myelodysplastic syndrome
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2020)
  • To describe the adverse event profile and tolerability of PRT1419 [ 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 PRT1419 [ Time Frame: Baseline through approximately 2 years ]
    PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration
  • To describe any anti-tumor activity of PRT1419 [ Time Frame: Baseline through approximately 2 years ]
    Anti-tumor activity of PRT1419 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 PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies
Official Title  ICMJE A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies
Brief Summary This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with relapsed/refractory hematologic malignancies. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.
Detailed Description This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients in two cohorts as part of a 28-day treatment cycle in adult patients with multiple myeloma (MM), non-Hodgkin's lymphoma (NHL), acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Cohort A will evaluate PRT1419 administered as monotherapy in patients with either AML and/or high-risk MDS. Cohort B will evaluate PRT1419 administered as monotherapy in patients with NHL or MM. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.
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
  • Multiple Myeloma
  • Acute Myeloid Leukemia
  • Non Hodgkin Lymphoma
  • Myelodysplastic Syndromes
Intervention  ICMJE Drug: PRT1419
PRT1419 will be administered orally
Study Arms  ICMJE Experimental: PRT1419
PRT1419 will be administered orally
Intervention: Drug: PRT1419
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 2, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Left ventricular ejection fraction of ≥50%
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial
  • Patients must have recovered from the effects of any prior cancer related therapy, radiotherapy or surgery (toxicity ≤ Grade 1)
  • All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 14 days, whichever is longer before study entry
  • AML patients only: Pathologically confirmed diagnosis of AML as defined by the WHO Classification and patients with targeted mutations must have been treated with appropriate therapy for their disease
  • MDS patients only: Intermediate, high, or very high risk by International Prognostic Scoring System-Revised [IPSS-R] criteria that is relapsed or refractory to approved therapies
  • NHL patients only: Histologically or cytologically confirmed NHL, including B- and T-cell lymphomas that is relapsed or refractory or intolerant to approved therapies. Must have one lesion that can be measured for response
  • MM patients only: Measurable disease defined by one or more of the following: Serum M-protein ≥ 0.5 g/dL, Urine M-protein ≥ 200 mg/24 hours, Serum Free Light Chain (sFLC) > 10 mg/dL with normal serum FLC ratio. Presence of soft tissue plasmacytoma confirmed by imaging
  • NHL and MM patients only: must have the following lab values within 14 days prior to study Day 1:

    • ANC ≥1.0 x 10˄3 μL
    • Platelet count ≥50,000 μL

Exclusion Criteria:

  • Known hypersensitivity to any of the components of PRT1419
  • Female patients who are pregnant or lactating
  • Mean QTcF interval of >480 msec
  • History of heart failure, additional risk factors for arryhthmias or requiring concomitant medications that prolong the QT/QTc interval
  • Hematopoietic stem-cell transplant < 90 days or have GVHD Grade >1 at study entry
  • Uncontrolled intercurrent illnesses
  • Treatment with strong inhibitors of CYP2C8 and/or P-glycoprotein 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
  • Prior exposure to an MCL1 inhibitor
  • History of another malignancy except:

    • Malignancy treated with curative intent with no known active disease for >2 years at study entry
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    • Adequately treated carcinoma in situ without evidence of disease
    • Other concurrent low-grade malignancies (i.e chronic lymphocytic leukemia (Rai 0)) may be considered after consultation with Sponsor.
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 302-644-5434 PRT1419-01Study@Preludetx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04543305
Other Study ID Numbers  ICMJE PRT1419-01
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 December 2020

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