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
44336
clinical trials with a EudraCT protocol, of which
7366
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 ).
7 result(s) found for: Claudin.
Displaying page 1 of 1.
EudraCT Number: 2018-000519-26
Sponsor Protocol Number: 8951-CL-0302
Start Date*: 2019-02-13
Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
Full Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared with Placebo Plus CAPOX as First-line Treatment of Subjects with Claudin (CLD...
Medical condition: Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or
Gastroesophageal Junction (GEJ) Adenocarcinoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10001150
Adenocarcinoma gastric
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:IE(Completed)NL(Completed)ES(Restarted)AT(Prematurely Ended)PT(Trial now transitioned)GR(Completed)GB(GB - no longer in EU/EEA)DE(Prematurely Ended)HR(Completed)RO(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2017-002567-17
Sponsor Protocol Number: 8951-CL-0301
Start Date*: 2018-07-13
Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
Full Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of IMAB362 Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Po...
Medical condition: Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10001150
Adenocarcinoma gastric
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:FR(Trial now transitioned)GB(GB - no longer in EU/EEA)DE(Trial now transitioned)BE(Trial now transitioned)ES(Ongoing)PL(Trial now transitioned)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2017-002566-50
Sponsor Protocol Number: 8951-CL-0103
Start Date*: 2018-10-02
Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
Full Title: A Phase 2 Study of IMAB362 as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma whos...
Medical condition: Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10066354
Adenocarcinoma of the gastroesophageal junction
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10071114
Metastatic gastric adenocarcinoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10001150
Adenocarcinoma gastric
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:FR(Trial now transitioned)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2018-002551-15
Sponsor Protocol Number: 8951-CL-5201
Start Date*: 2019-02-05
Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
Full Title: A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatmen...
Medical condition: First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004864
10033599
Pancreatic adenocarcinoma metastatic
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:FR(Trial now transitioned)ES(Ongoing)IE(Trial now transitioned)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2012-000394-23
Sponsor Protocol Number: SOLTI-1007
Start Date*: 2012-08-06
Sponsor Name:SOLTI
Full Title: A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVENĀ®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer
Medical condition: Patients at Stage I-II HER2-negative breast cancer
Sponsor Name:ISTITUTO NAZIONALE PER LA CURA TUMORI
Full Title: Peritoneal Mesothelioma: Optimize Outcomes by the Integration of new Prognostic Factors and Potential Therapeutic Targets in a Individualized Treatment based on Molecular Characterization and Chemo...
Medical condition: Patients affected by diffuse malignant peritoneal mesothelioma treated by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, without any factor precluding the performance of syste...
Disease:
Version
SOC Term
Classification Code
Term
Level
14.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced sol...
Medical condition: Claudin 6 (CLDN6)-positive advanced solid tumors
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10043302
Testicular cancer
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10033128
Ovarian cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10014733
Endometrial cancer
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10007460
Carcinoma of unknown primary
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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