Guadecitabine Extension Study

Sponsor
Astex Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03603964
Collaborator
(none)
250
21
1
38.4
11.9
0.3

Study Details

Study Description

Brief Summary

This is a multicenter, open-label extension study for subjects who participated in a previous Astex-sponsored guadecitabine clinical study (including but not limited to SGI-110-01, SGI-110-04, SGI-110-06, and SGI-110-07).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Subjects who were still receiving treatment with guadecitabine and in the opinion of the investigator were still benefitting from treatment at the time of database close of the original study will be eligible to participate in this extension study. Approximately 250 subjects could be enrolled.

Subjects will attend clinic visits on Days 1-5 of each 28-day cycle to receive treatment with guadecitabine. Data collection will be limited to treatment exposure, adverse events, concomitant medications, limited laboratory parameters, and survival status.

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
Actual Study Start Date :
Jul 23, 2018
Actual Primary Completion Date :
Oct 4, 2021
Actual Study Completion Date :
Oct 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Guadecitabine

Subjects will receive guadecitabine treatment at the same dose that they were receiving in the last cycle of their prior study or at a different dose as guided by the dose adjustment guidelines in the prior study protocol. Treatment may continue as long as the subject continues to benefit based on investigator judgment.

Drug: Guadecitabine
Guadecitabine
Other Names:
  • SGI-110
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Events [2 years]

    Secondary Outcome Measures

    1. Survival Status [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Previous participation in an Astex-sponsored guadecitabine clinical trial (including but not limited to SGI-110-01, SGI-110-04, SGI-110-05, SGI-110-06, and SGI-110-07), in which the subject was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.

    2. Subject is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.

    3. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure.

    4. Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures while receiving treatment with guadecitabine and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving study treatment and for at least 3 months after completing guadecitabine treatment.

    Exclusion Criteria:
      1. Any subject who, in the opinion of the investigator, may have other conditions, organ dysfunction, or have safety data from their prior study participation that suggest that the risks of continuing treatment with guadecitabine may outweigh the benefits.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Buffalo New York United States 14263
    2 Duke Cancer Center Durham North Carolina United States 27705
    3 Ohio State University Columbus Ohio United States 43210
    4 Temple University Philadelphia Pennsylvania United States 19111
    5 Center for Blood Cancers Nashville Tennessee United States 37203
    6 Medizinische Universit├Ąt Graz Graz Styria Austria
    7 The Ottawa Hospital - General Ottawa Ontario Canada K1H 8L6
    8 Princess Margaret Cancer Center Toronto Ontario Canada M5G 2M9
    9 Rigshospitalet-Copenhagen University Hospital Copenhagen Denmark
    10 Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria Alessandria Italy
    11 Azienda Ospedaliera Universitaria San Martino Genova Italy
    12 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy
    13 Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine Udine Italy
    14 Tokai University Hospital Isehara-shi Japan 259-1193
    15 Japanese Red Cross Kyoto Daini Hospital Kyoto-shi Japan 602-8026
    16 Saga University Hospital Saga-shi Japan 849-8501
    17 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    18 Ulsan University Hospital Ulsan Korea, Republic of 44033
    19 Hospital Universitario 12 de Octubre Madrid Spain
    20 Mackay Memorial Hospital Taipei Taiwan
    21 National Taiwan University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • Astex Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astex Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT03603964
    Other Study ID Numbers:
    • SGI-110-12
    First Posted:
    Jul 27, 2018
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Astex Pharmaceuticals, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2022