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Clinical trials for Rovalpituzumab tesirine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • 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 ).  
     
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    4 result(s) found for: Rovalpituzumab tesirine. Displaying page 1 of 1.
    EudraCT Number: 2016-003726-17 Sponsor Protocol Number: M16-289 Start Date*: 2017-06-27
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have Firs...
    Medical condition: Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041067 Small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Completed) PT (Completed) GB (Completed) CZ (Completed) DE (Completed) HU (Completed) BE (Completed) LV (Completed) NL (Completed) GR (Completed) BG (Completed) PL (Completed) FR (Completed) ES (Completed) HR (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-003503-64 Sponsor Protocol Number: M16-298 Start Date*: 2017-06-12
    Sponsor Name:Abbvie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell L...
    Medical condition: Extensive Stage Small Cell Lung Cancer (ED SCLC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Prematurely Ended) AT (Completed) DK (Prematurely Ended) FI (Completed) IE (Completed) GB (Completed) SE (Completed) DE (Prematurely Ended) NL (Completed) LV (Prematurely Ended) PT (Prematurely Ended) HU (Completed) GR (Completed) PL (Completed) ES (Prematurely Ended) CZ (Completed) BG (Prematurely Ended) LT (Completed) BE (Completed) HR (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2016-003686-26 Sponsor Protocol Number: M16-300 Start Date*: 2017-08-28
    Sponsor Name:AbbVie Stemcentrx LLC
    Full Title: A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer
    Medical condition: Extensive-Stage Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041068 Small cell lung cancer extensive stage PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004506-42 Sponsor Protocol Number: SCRX001-002 Start Date*: 2016-04-25
    Sponsor Name:Stemcentrx Inc.
    Full Title: An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects with Relapsed or ...
    Medical condition: Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041070 Small cell lung cancer recurrent PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070308 Refractory cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) ES (Completed) PL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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