We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety, Pharmacokinetic and Pharmacodynamic Effect of KA2237 (PI3 Kinase p110β/δ Inhibitor) In B Cell Lymphoma

This study is currently recruiting participants.
Verified August 2017 by Karus Therapeutics Limited
Sponsor:
ClinicalTrials.gov Identifier:
NCT02679196
First Posted: February 10, 2016
Last Update Posted: August 21, 2017
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.
Information provided by (Responsible Party):
Karus Therapeutics Limited
  Purpose
Multiple ascending dose study to evaluate safety/tolerability, pharmacokinetic and pharmacodynamics effects of KA2237 (PI3 Kinase p110β/δ Inhibitor) in patients with B Cell Lymphoma and determine the maximum tolerated dose (MTD) in Part I of the study. In Part II, patients with B cell lymphoma will be treated with KA2237 at the MTD to evaluate safety and efficacy in the patient population.

Condition Intervention Phase
Lymphoma, B Cell Drug: KA2237 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Ascending Dose Study Evaluating the Safety/Tolerability, Pharmacokinetic and Pharmacodynamic Effects of KA2237 In Patients With B Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Karus Therapeutics Limited:

Primary Outcome Measures:
  • The occurrence of dose limiting toxicity (DLT); [ Time Frame: Day 28 of treatment ]
    any event with possible or probable relationship to study drug occurring up to day 28 from the start of treatment as assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.03


Secondary Outcome Measures:
  • Concentration (mg/ml) of KA2237 in serum/plasma over time (hours) [ Time Frame: 24 weeks ]
  • Concentration (mg/ml) of KA2237 in urine over time (hours) [ Time Frame: 24 weeks ]
  • Concentration (ng/ml) of key cytokine and intracellular signalling markers in immune cell subsets [ Time Frame: 24 weeks ]
  • Frequency of KA2237 related adverse events and laboratory abnormalities [ Time Frame: 24 weeks ]

Estimated Enrollment: 53
Study Start Date: July 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KA2237
Open label treatment with KA2237
Drug: KA2237
PI3 Kinase p110β/δ inhibitor
Other Name: PI3 Kinase p110β/δ inhibitor

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years at the screening visit.
  2. Has given written consent to participate in the study.
  3. Has B-cell lymphoma refractory to or intolerant of established therapy known to provide clinical benefit for their condition and having received rituximab as a single agent or in combination with other therapies.
  4. Disease status requirement: Measurable disease defined as the presence of ≥ 1 nodal lesion that measures ≥ 1.5 cm in a single dimension as assessed by X-ray Computed Tomography (CT) (Positron Emission Tomography (PET/CT), or magnetic resonance imaging [MRI]
  5. Eastern Co-operative Oncology Group (ECOG) performance status of ≤ 2.
  6. For men and women of child-bearing potential, willing to use adequate contraception

Exclusion Criteria:

  1. Subject is a chronic alcoholic (intake > 35 units of alcohol (>5 bottles of wine weekly)) or drug abuser
  2. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, may compromise the subject's ability to participate in this study
  3. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following the last dose of investigational product
  4. Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal disease (estimated glomerular filtration rate (eGFR) <30ml/min), hepatic (Alanine transaminase (ALT) 2.5 times upper limit of normal (>2.5xULN), bilirubin > 2x ULN), hematological (absolute neutrophil count (ANC) <1.0 x 109/L, platelet count <75x109/L or requires regular platelet transfusions to maintain a platelet count ≥ 75 x 109/L , hemoglobin <9g/dL), endocrine (glycated Haemoglobin (HbA1c)>7% or random glucose >200mg/dL), pulmonary (Forced Expiratory Volume in 1 second (FEV1) <70% of predicted value), cardiac (New York Heart Association (NYHA)) class III/IV, or neurological disease
  5. Has had an allogeneic stem cell transplant with current active graft-versus-host-disease.
  6. Has known active central nervous system involvement of the malignancy.
  7. Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.
  8. Has a positive test for human immunodeficiency virus (HIV) antibodies.
  9. Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible.
  10. Disease-related exclusions

    • Had treatment with a short course of corticosteroids (> 10mg daily prednisone equivalents) for symptom relief within 1-week prior to screening.
    • Has poorly controlled diabetes mellitus (HbA1c >7% or random glucose >200mg/dL)
    • Known tuberculosis (TB) disease or latent TB infection
    • Has chronic, active colitis
  11. Medication related exclusions

    • Had alemtuzumab therapy within 12-weeks prior to screening.
    • Has taken a medication that is a potent inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 1-week prior to screening.
    • The subject has previously participated in this study.
    • The subject has participated or is currently participating in another study of an investigational medicine or medical device (radiotherapy, radio-immunotherapy, biological therapy, chemotherapy), within 4-weeks prior to screening.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679196


Contacts
Contact: Loretta Nastoupil, MD 713-563-5656 lnastoupil@mdanderson.org

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Loretta Nastoupil, MD       lnastoupil@mdanderson.org   
Principal Investigator: Loretta Nastoupil, MD         
Sponsors and Collaborators
Karus Therapeutics Limited
  More Information

Responsible Party: Karus Therapeutics Limited
ClinicalTrials.gov Identifier: NCT02679196     History of Changes
Other Study ID Numbers: KTP-002
First Submitted: January 29, 2016
First Posted: February 10, 2016
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin