Back to resultsTolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Primary Purpose
Relapsed or Refractory Hematologic Malignancies
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trichostatin A
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Hematologic Malignancies focused on measuring Hematologic, Malignancies, Cancer, Blood
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥ 18 years at the time of signing informed consent;
- Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies;
- Presence of measurable or evaluable disease;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- Contraceptives or other approved avoidance of pregnancy measures
Exclusion Criteria:
- Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression;
- Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);
- Undergone major surgery ≤ 2 weeks prior to starting study drug;
- Evidence of mucosal or internal bleeding;
- Impaired cardiac function or conduction defect;
- Concurrent severe and/or uncontrolled medical conditions
Sites / Locations
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trichostatin A
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
Measured by spontaneous reporting of adverse events (AEs)
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
Secondary Outcome Measures
Full Information
NCT ID
NCT03838926
First Posted
February 11, 2019
Last Updated
February 11, 2019
Sponsor
Vanda Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03838926
Brief Title
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Official Title
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Hematologic Malignancies
Keywords
Hematologic, Malignancies, Cancer, Blood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trichostatin A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Trichostatin A
Intervention Description
Intravenous Infusion
Primary Outcome Measure Information:
Title
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
Description
Measured by spontaneous reporting of adverse events (AEs)
Time Frame
Up to 24 months
Title
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥ 18 years at the time of signing informed consent;
Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies;
Presence of measurable or evaluable disease;
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
Contraceptives or other approved avoidance of pregnancy measures
Exclusion Criteria:
Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression;
Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);
Undergone major surgery ≤ 2 weeks prior to starting study drug;
Evidence of mucosal or internal bleeding;
Impaired cardiac function or conduction defect;
Concurrent severe and/or uncontrolled medical conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Email
clinicaltrials@vandapharma.com
Facility Information:
Facility Name
Vanda Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
12. IPD Sharing Statement
Learn more about this trial
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
We'll reach out to this number within 24 hrs