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A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

This study is currently recruiting participants.
Verified February 2017 by Kadmon Corporation, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02841995
First Posted: July 22, 2016
Last Update Posted: February 8, 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):
Kadmon Corporation, LLC
  Purpose
This study is being conducted to evaluate the safety, tolerability, and activity of KD025 in adult subjects with chronic Graft versus Host Disease (cGVHD).

Condition Intervention Phase
Graft vs Host Disease Drug: KD025 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Dose-Escalation, Open-Label Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:
  • Overall response criteria (PR + CR) [ Time Frame: 24 weeks ]
    To evaluate overall response from baseline to 24 weeks after dosing with KD025 200 mg QD, KD025 200 mg BID, or KD025 400 mg QD in subjects with cGVHD. The overall response will be evaluated through the NIH Consensus Development Project on Clinical Trials in cGVHD.

  • Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ]
    To evaluate the safety and tolerability of KD025 200 mg QD, KD025 200 mg BID, or KD025 400 mg QD when administered for 24 weeks to subjects with cGVHD


Estimated Enrollment: 48
Study Start Date: August 2016
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KD025 200 mg QD
Two 100 mg capsules (200 mg) of KD025 once daily. Subjects should take 2 capsules with their morning meal or within 5 minutes of completing a meal.
Drug: KD025
Other Name: SLx-2119
Experimental: KD025 200 mg BID
Two 100 mg capsules (200 mg) of KD025 twice daily. Subjects should take 2 capsules with their morning meal or within 5 minutes of completing a meal and 2 capsules with their evening meal or within 5 minutes of completing a meal.
Drug: KD025
Other Name: SLx-2119
Experimental: KD025 400 mg QD
Four 100 mg capsules (400 mg) of KD025 once daily. Subjects should take 4 capsules with their morning meal or within 5 minutes of completing a meal.
Drug: KD025
Other Name: SLx-2119

Detailed Description:
A total of 48 subjects will be enrolled to receive orally administered KD025 200 mg QD (once daily), KD025 200 mg BID (twice daily), or KD025 400 mg QD. Study drug will be administered in 28-day cycles for 6 cycles (24 weeks). Subjects may receive study drug in the inpatient or outpatient setting.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adult male and female subjects at least 18 years of age who have had allogenic bone marrow transplant (BMT) or hematopoietic stem cell transplantation (HSCT).
  • Receiving glucocorticoid therapy and calcineurin therapy or glucocorticoid therapy alone for cGVHD at study entry. Subjects on calcineurin therapy only, without glucocorticoid therapy, are not eligible. Subjects also receiving other therapies thought not to be immunosuppressive (such as extracorporeal photopheresis; ECP), will be considered for enrollment in this study on a case-by-case basis.
  • Have persistent active cGVHD manifestations, as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD, after at least 2 months of steroid therapy.
  • No more than 3 prior lines of treatment for cGVHD.
  • Karnofsky Performance Scale of > 40.
  • Adequate organ and bone marrow functions evaluated during the 14 days prior to enrollment as follows:

    • Absolute neutrophil count ≥ 1.5 × 109/L (without myeloid growth factors within 1 week of study entry)
    • Platelet count ≥ 50 × 109/L (without transfusion or thrombopoietin or thrombopoietin analogues within 2 weeks of study entry)
  • Adequate safety laboratory values:

    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
    • ALT and AST ≤ 3 × ULN
    • Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 using the MDRD-4 variable formula
  • Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti estrogens, or ovarian suppression.
  • Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug.
  • Sexually active women of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:

    • IUD plus one barrier method;
    • Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method;
    • 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or
    • A vasectomized partner
  • For male patients who are sexually active and who are partners of premenopausal women: agreement to use two forms of contraception as in criterion 10 above during the treatment period and for at least 3 months after the last dose of study drug.
  • Able to provide written informed consent prior to the performance of any study-specific procedures.

Exclusion Criteria:

  • Female subject who is pregnant or breastfeeding.
  • Receiving an investigational GVHD treatment within 28 days of study entry.
  • Has acute GVHD.
  • Taking any medication known to be a moderate or strong inhibitor of the CYP3A4 isozyme or any drugs that are moderate or strong CYP3A4 inducers.
  • History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease or coronary artery disease).
  • Regular and excessive use of alcohol within the 6 months prior to study entry defined as alcohol intake > 14 drinks per week in a man or > 7 drinks per week in a woman. Approximately 10 g of alcohol equals one "drink" unit. One unit equals 1 ounce of distilled spirits, one 12-ounce beer, or one 4-ounce glass of wine.
  • Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment, with the exception of completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection.
  • Relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
  • Has had previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor.
  • Taking other immunosuppressant drugs for GVHD, including mTor inhibitors (Note: Only steroids, calcineurin inhibitors, and ECP are acceptable).
  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): NCT02841995


Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Amandeep Salhotra, MD       asalhotra@coh.org   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Aleksander Lazaryan, MD       alazarya@umn.edu   
United States, Ohio
Oncolology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Nicole Given    513-751-2273      
United States, Tennessee
Tennessee Oncology, PLLC. Recruiting
Nashville, Tennessee, United States, 37203
Contact: Clinical Trials Office    877-691-7274    asksarah@sarahcannon.com   
Vanderbilt University - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Information Program    800-811-8480      
United States, Texas
Methodist Physician Practices Recruiting
San Antonio, Texas, United States, 78229
Contact: Behyar Zoghi, MD, PhD    210-575-6951      
United States, Washington
Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
Contact: Stephanie J Lee, MD    206-667-5160    sjlee@fredhutch.org   
Sponsors and Collaborators
Kadmon Corporation, LLC
  More Information

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02841995     History of Changes
Other Study ID Numbers: KD025-208
First Submitted: July 20, 2016
First Posted: July 22, 2016
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kadmon Corporation, LLC:
cGVHD
Allogeneic hematopoietic stem cell transplantation
Immune System Diseases
Steroid refractory chronic graft vs host disease (cGVHD)
Bone Marrow Transplantation
Anti-Inflammatory Agents
Glucocorticoids
Corticosteroids

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases