Acute Myeloid Leukemia Clinical Trial

Guadecitabine Extension Study

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).

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Full Description

Participants 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.

Participants 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Previous participation in an Astex-sponsored guadecitabine clinical trial [including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT03603964), SGI-110-05, SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)], in which the participant was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
Participant is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
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.
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 participant 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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT03603964

Recruitment Status:

Terminated

Sponsor:

Astex Pharmaceuticals, Inc.

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There are 12 Locations for this study

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Roswell Park
Buffalo New York, 14263, United States
Duke Cancer Center
Durham North Carolina, 27705, United States
Ohio State University
Columbus Ohio, 43210, United States
Temple University
Philadelphia Pennsylvania, 19111, United States
Center for Blood Cancers
Nashville Tennessee, 37203, United States
Medizinische Universität Graz
Graz Styria, , Austria
The Ottawa Hospital - General
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
Rigshospitalet-Copenhagen University Hospital
Copenhagen , , Denmark
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria , , Italy
Azienda Ospedaliera Universitaria San Martino
Genova , , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano , , Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
Udine , , Italy
Tokai University Hospital
Isehara-shi , 259-1, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto-shi , 602-8, Japan
Saga University Hospital
Saga-shi , 849-8, Japan
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Hospital Universitario 12 de Octubre
Madrid , , Spain
Mackay Memorial Hospital
Taipei , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT03603964

Recruitment Status:

Terminated

Sponsor:


Astex Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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