Guadecitabine Extension Study

Acute Myeloid Leukemia Clinical Trial

Official title:

An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03603964
• Other study ID #: SGI-110-12
• Status: Terminated
• Phase: Phase 2
• Start date: July 18, 2018
• Est. completion date: October 4, 2021

Study information

• Verified date: April 2023
• Source: Astex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label extension study for participants who participated in a previous Astex-sponsored guadecitabine clinical study [including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)].

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Participant 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 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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myeloid Dysplastic Syndrome

Intervention

Drug:
• Guadecitabine
Guadecitabine

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz	Styria
Canada	The Ottawa Hospital - General	Ottawa	Ontario
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Denmark	Rigshospitalet-Copenhagen University Hospital	Copenhagen
Italy	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
Japan	Tokai University Hospital	Isehara-shi
Japan	Japanese Red Cross Kyoto Daini Hospital	Kyoto-shi
Japan	Saga University Hospital	Saga-shi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Spain	Hospital Universitario 12 de Octubre	Madrid
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
United States	Roswell Park	Buffalo	New York
United States	Ohio State University	Columbus	Ohio
United States	Duke Cancer Center	Durham	North Carolina
United States	Center for Blood Cancers	Nashville	Tennessee
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Italy,  Japan,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal finding in laboratory tests or other diagnostic procedures), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs are defined as events that occur or worsen on or after the date of the first study treatment (Cycle 1 Day 1 {C1D1}) until 30 days after the last dose of study treatment or the start of an alternative anti-cancer treatment, whichever occurs first.	From the start of study treatment until 30 days after the last dose of study treatment or prior to the participant receiving alternative anticancer therapy, whichever occurs first.
Secondary	Overall Survival	Overall survival was defined as the number of days from the time of randomization in the prior study to the date of death (regardless of cause). Participants without a documented death date at the time of analysis were censored at the last date known alive. Survival time in days = (earliest of date of death or censoring) - (randomization date in the prior study).	From randomization in the prior study to the date of death