Trial Outcomes & Findings for Guadecitabine Extension Study (NCT NCT03603964)

Last Updated: 2024-08-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

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.

Results posted on

2024-08-27

Participant Flow

Participants were enrolled in the study at 32 study centers in the United States, Spain, Italy, Canada, Japan, France, Germany, Poland, Finland, South Korea, Taiwan, Czech Republic and Australia from 18 July 2018 to 30 November 2020.

35 participants who had participated in a previous Astex-sponsored guadecitabine clinical study (SGI-110-01 {NCT01261312}, SGI-110-04 {NCT02348489}, SGI-110-06 {NCT02920008}, and SGI-110-07 {NCT02907359}) and were still benefitting from the treatment at the time of database close of the original study, were enrolled in this extension study.

Participant milestones

Participant milestones
Measure	Guadecitabine 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 up to a maximum of 26 cycles.
Overall Study STARTED	35
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Guadecitabine 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 up to a maximum of 26 cycles.
Overall Study Death	9
Overall Study Withdrawal by participant	7
Overall Study Study terminated by Sponsor	19

Baseline Characteristics

Guadecitabine Extension Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guadecitabine n=35 Participants Participants received guadecitabine, SC injection on Days 1-5 of each 28-day cycle, up to 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 up to a maximum of 26 cycles.
Age, Continuous	75.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Safety population included all participants who received any amount of study treatment.

Outcome measures

Outcome measures
Measure	Guadecitabine n=35 Participants Participants received guadecitabine, SC injection on Days 1-5 of each 28-day cycle, up to 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 up to a maximum of 26 cycles.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	31 Participants

SECONDARY outcome

Timeframe: From randomization in the prior study to the date of death

Population: Efficacy population included all participants who received any amount of study treatment.

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).

Outcome measures

Outcome measures
Measure	Guadecitabine n=35 Participants Participants received guadecitabine, SC injection on Days 1-5 of each 28-day cycle, up to 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 up to a maximum of 26 cycles.
Overall Survival	2583.0 days Interval 1422.0 to Not estimable with current data due to early termination.

Adverse Events

Guadecitabine

Serious events: 20 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Guadecitabine n=35 participants at risk Participants received guadecitabine, SC injection on Days 1-5 of each 28-day cycle, up to 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 up to a maximum of 26 cycles.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 7/35 • 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. Safety population included all participants who received any amount of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
General disorders Asthenia	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Immune system disorders Anaphylactic reaction	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Pneumonia	17.1% 6/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Sepsis	8.6% 3/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Bronchopulmonary aspergillosis	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Clostridium difficile colitis	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Gastroenteritis	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Herpes zoster	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Infection	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Pneumonia viral	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Infections and infestations Soft tissue infection	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Patella fracture	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Nervous system disorders Cerebrovascular accident	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Nervous system disorders Cognitive disorder	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.9% 1/35 • 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. Safety population included all participants who received any amount of study drug.

Other adverse events

Adverse event data not reported

Additional Information

Taiho Central

Taiho Oncology, Inc.

Phone: 609-250-7336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place