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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid tumors (including lymphoma), acute myeloid leukemia (AML), or high-risk myelodysplastic syndrome (MDS).

Official Title

A Phase 1b Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX51107 in Subjects With Advanced Malignancies

Keywords

Solid Tumors Acute Myeloid Leukemia Myelodysplastic Syndrome PLX51107 Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia

Eligibility

You can join if…

Open to people ages 18 years and up

  • Confirmed diagnosis of an advanced malignancy in one of two treatment groups:

Treatment Group A: any advanced solid tumor (including lymphomas); Treatment Group B:relapsed or refractory AML or high-risk MDS, defined as IPSS INT-2 or greater disease(Maes 1999).

  • Progressed following at least 1 line of prior anti-cancer therapy for the advanced disease and there is no further standard therapeutic option available (including subjects who are intolerant to the approved/available therapies)
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2
  • Life expectancy ≥ 3 months
  • Adequate organ function as demonstrated by the following laboratory values (collected within 10 days of treatment initiation) and as appropriate for the disease under study.
  • Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
  • Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug
  • All associated toxicity, except grade 2 alopecia, from previous cancer therapy must be resolved (to ≤ Grade 1 or Baseline) prior to study treatment administration (Grade 2 alopecia is allowed).
  • Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.

You CAN'T join if...

  • Prior exposure to a bromodomain inhibitor
  • Active graft versus host disease
  • Known uncontrolled fungal, bacterial, and/or viral infection ≥ Grade 2
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Presence of symptomatic or uncontrolled central nervous system or leptomeningeal metastases (Note: Subjects with stable, treated brain metastases are eligible for this trial. However, subjects must not have required steroid treatment for their brain metastases within 30 days of Screening.)
  • A diagnosis of acute promyelocytic leukemia (APL) or chronic myeloid leukemia (CML) in blast crisis
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Clinically significant cardiac arrhythmias including brady-arrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded.
  • Congenital long QT syndrome or subjects taking concomitant medications known to prolong the QT interval except treatment required for infections with a low risk of QTc prolongation.
  • Subjects on active anticoagulation therapy including warfarin, factor Xa inhibitors,thrombin inhibitors or heparin
  • QTcF ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening
  • History of clinically significant cardiac disease or congestive heart failure >New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.
  • Hypertension as defined by systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical management
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident(including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication)
  • Inability to take oral medication or significant nausea and vomiting, malabsorption,or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption
  • Non-healing wound, ulcer, or bone fracture
  • Known HIV-positive individuals on combination antiretroviral therapy
  • Subjects with known active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  • Strong CYP3A4 and 2C8 inhibitors or inducers or CYP3A4 substrate drugs with a narrow therapeutic range within 14 days or 5 drug half-lives, whichever is longer, before start of study drug
  • Subjects with > Grade 1 serum potassium, magnesium, or calcium levels
  • Active secondary malignancy (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g., chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix
  • Major surgery or significant traumatic injury within 14 days prior to Cycle 1 Day 1
  • Receipt of anti-cancer medications or investigational drugs within the following interval before the first administration of study drug:
  • < 14 days or 5 drug half-lives, whichever is shorter, for chemotherapy and investigational agents
  • < 5 half-lives for all other anti-cancer medications, or Sponsor approval
  • leukopheresis and/or hydroxyurea for leukocytosis is allowed any time prior to and during the study to reduce WBC
  • Radiation therapy within 14 days prior to Cycle 1 Day 1
  • Any medical condition(s) that, in the opinion of the Investigator, would interfere with the study endpoints or the subject's ability to participate in the study

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco, California, 94143, United States
  • South Texas Accelerated Research Therapeutics accepting new patients
    San Antonio, Texas, 78229, United States
  • University of Chicago not yet accepting patients
    Chicago, Illinois, 60637, United States
  • Karmanos Cancer Institute not yet accepting patients
    Detroit, Michigan, 48201, United States
  • The Ohio State University Stephanie Spielman Comprehensive Breast Center accepting new patients
    Columbus, Ohio, 43212, United States
  • MUSC/ Hollings Cancer Center accepting new patients
    Charleston, South Carolina, 29425, United States
  • Thomas Jefferson University accepting new patients
    Philadelphia, Pennsylvania, 19107, United States
  • Columbia University Medical Center accepting new patients
    New York, New York, 10032, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Plexxikon
ID
NCT02683395
Phase
Phase 1
Lead Scientist
Catherine Smith
Study Type
Interventional
Last Updated
October 25, 2017
I’m interested in this study!