Guadecitabine Extension Study

NCT03603964 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: SGI-110-12
• Study Type: interventional
• Target: 35
• Locations: 9 countries
• Sites: 21

Brief Summary

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

Conditions

Acute Myeloid Leukemia; Myeloid Dysplastic Syndrome

Keywords

Guadecitabine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  From randomization in the prior study to the date of death

Study Arms (1)

Guadecitabine

EXPERIMENTAL

Participants received guadecitabine, subcutaneous (SC) injection on Days 1-5 of each 28-day cycle 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.

Drug: Guadecitabine

Interventions

Guadecitabine DRUG

Guadecitabine

Also known as: SGI-110

Guadecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (21)

Roswell Park

Buffalo, New York, 14263, United States

Location

Duke Cancer Center

Durham, North Carolina, 27705, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Temple University

Philadelphia, Pennsylvania, 19111, United States

Location

Center for Blood Cancers

Nashville, Tennessee, 37203, United States

Location

Medizinische Universität Graz

Graz, Styria, Austria

Location

The Ottawa Hospital - General

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location

Rigshospitalet-Copenhagen University Hospital

Copenhagen, Denmark

Location

Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

Alessandria, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genova, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

Udine, Italy

Location

Tokai University Hospital

Isehara-shi, 259-1193, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, 602-8026, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

guadecitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

The study was terminated early not due to participant safety.

Results Point of Contact

• Title: Taiho Central
• Organization: Taiho Oncology, Inc.

clinicaltrialinfo@taihooncology.com

609-250-7336

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: July 18, 2018
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: August 27, 2024
• Results First Posted: April 26, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); AU (1); JP (3); IT (4); TW (2); KR (2); ES (1); DK (1); US (5)