interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44379
clinical trials with a EudraCT protocol, of which
7391
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
2 result(s) found for: Epimer.
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EudraCT Number: 2019-003281-40
Sponsor Protocol Number: ASTX727-03
Start Date*: 2021-10-19
Sponsor Name:Taiho Oncology, Inc.
Full Title: A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)
Medical condition: Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004851
10028536
Myelodysplastic syndromes
HLT
27.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028533
Myelodysplastic syndrome
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Trial now transitioned)BE(Trial now transitioned)ES(Restarted)IT(Completed)
Trial results:(No results available)
EudraCT Number: 2018-003942-18
Sponsor Protocol Number: ASTX727-06
Start Date*: 2021-09-03
Sponsor Name:Taiho Oncology, Inc.
Full Title: An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
Medical condition: Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or solid tumors
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10000880
Acute myeloid leukaemia
PT
27.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10028533
Myelodysplastic syndrome
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065252
Solid tumor
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10009018
Chronic myelomonocytic leukaemia
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:SK(Trial now transitioned)BG(Trial now transitioned)ES(Completed)LT(Completed)HU(Trial now transitioned)AT(Ongoing)FR(Completed)DE(Trial now transitioned)IT(Completed)RO(Trial now transitioned)
Trial results:(No results available)
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