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Early termination not due to patient safety
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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)].
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guadecitabine | Drug | Guadecitabine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park | Buffalo | New York | 14263 | United States | ||
| Duke Cancer Center |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Efficacy population included all participants who received any amount of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Guadecitabine | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | 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. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guadecitabine | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
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The study was terminated early not due to participant safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho Central | Taiho Oncology, Inc. | 609-250-7336 | clinicaltrialinfo@taihooncology.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2018 | Jul 20, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 3, 2021 | Jul 20, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C580831 | guadecitabine |
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| 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 8L6 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 2M9 | 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 | Milan | Italy |
| Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine | Udine | Italy |
| Tokai University Hospital | Isehara-shi | 259-1193 | Japan |
| Japanese Red Cross Kyoto Daini Hospital | Kyoto | 602-8026 | Japan |
| Saga University Hospital | Saga | 849-8501 | Japan |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Mackay Memorial Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Guadecitabine |
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. |
|
|
| 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). | Efficacy population included all participants who received any amount of study treatment. | Posted | Median | 95% Confidence Interval | days | From randomization in the prior study to the date of death |
|
|
|
| 9 |
| 35 |
| 20 |
| 35 |
| 0 |
| 35 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |