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Clinical trials for Trilaciclib

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
  • 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   44334   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7 result(s) found for: Trilaciclib. Displaying page 1 of 1.
    EudraCT Number: 2016-004466-26 Sponsor Protocol Number: G1T28-04 Start Date*: 2017-07-10
    Sponsor Name:G1 Therapeutics
    Full Title: Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients with Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
    Medical condition: Locally recurrent or metastatic Triple Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SI (Completed) HR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2021-000186-32 Sponsor Protocol Number: G1T28-210 Start Date*: 2021-08-11
    Sponsor Name:G1 Therapeutics, Inc.
    Full Title: A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib versus Placebo in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated with Docetaxel in the 2nd/3rd Line Setting (P...
    Medical condition: Metastatic Non small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-004930-39 Sponsor Protocol Number: G1T28-208 Start Date*: 2021-09-30
    Sponsor Name:G1 Therapeutics, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metasta...
    Medical condition: Locally Advanced Unresectable or Metastatic Triple Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10084066 Triple negative breast cancer metastatic LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BG (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-000205-24 Sponsor Protocol Number: G1T28-209 Start Date*: 2021-10-28
    Sponsor Name:G1 Therapeutics, Inc.
    Full Title: A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered with First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients with Untreated, Locally Advanced or Meta...
    Medical condition: Untreated, Locally Advanced or Metastatic Urothelial Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003826-25 Sponsor Protocol Number: G1T28-207 Start Date*: 2020-12-08
    Sponsor Name:G1 Therapeutics, Inc.
    Full Title: PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer
    Medical condition: Prevention of chemotherapy-induced myelosuppression in patients receiving FOLFOXIRI/bevacizumab for mCRC
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    23.1 100000004851 10028585 Myelosuppression adult LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SK (Completed) PL (Completed) HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000358-20 Sponsor Protocol Number: G1T28-05 Start Date*: 2017-07-12
    Sponsor Name:G1 Therapeutics
    Full Title: Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer
    Medical condition: Untreated Extensive-Stage Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 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: EE (Completed) LV (Completed) BG (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004611-13 Sponsor Protocol Number: G1T28-03 Start Date*: 2017-03-16
    Sponsor Name:G1 Therapeutics
    Full Title: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
    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: SK (Completed) BE (Completed) SI (Completed) HR (Completed)
    Trial results: (No results available)
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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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