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Poster Display session 1

1696 - Demonstrating the Changing Trends in Phase 1 Clinical Trials


28 Sep 2019


Poster Display session 1


Clinical Research

Tumour Site


Christina Guo


Annals of Oncology (2019) 30 (suppl_5): v159-v193. 10.1093/annonc/mdz244


C. Guo, R. Kelly, J. Desai, B. Tran

Author affiliations

  • Medical Oncology, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU


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Abstract 1696


Early drug development and phase 1 (P1) clinical trials have changed dramatically in the past decade, as targeted therapies and then immune-oncology evolved. Understanding the changing trends in P1 trials allows more targeted resource investment at the site level, but also at the industry level. We describe the changes in the P1 trial landscape in solid tumours over the past decade.


P1 trials registered on ClinicalTrials.gov to start between 1/1/2009-31/12/2018 were extracted using the parameters: cancer, ≥18 years (yr) old, active, recruiting, completed, (early) P1 and interventional. Of the 7,870 trials identified, 3,031 were excluded on the following basis: not conducted in patients with solid tumours, directed at supportive care, solely involving radiotherapy (RT), testing of a device or procedure or solely involving dietary interventions. The 4,839 eligible studies were categorized by treatment type, tumor type, start date and study location. Studies were independently reviewed by two clinicians.


In the past decade, there was an average increase of 5%/yr in the number of P1 registered, reflected by substantial increases in trials investigating immune-oncology agents (IO) (average increase: 36%/year) and cell therapies (CT) (average increase: 17%/yr). P1 trials using chemotherapy (C) (average decrease: 1%/yr) or targeted therapies (T) (average decrease: 1%/yr) have plateaued. Clinical trials combining IO with T or C or RT increased by an average of 45%/yr. Most P1 studies (41%) enrolled multiple tumour types. Studies frequently involved North American (68.5%), European (29.3%) and Asia Pacific sites (34%). The inclusion of Asia Pacific sites increased most substantially (average increase: 8%/year). P1 Trials Classified by Type of Therapy (2009-2018)Table:


2009-104% (30)39% (324)66% (557)5% (39)839
2011-1212% (89)36% (276)64% (491)3% (25)767
2013-1417% (141)32% (258)57% (467)6% (47)814
2015-1633% (364)29% (320)48% (529)9% (98)1095
2017-1844% (581)23% (305)40% (524)11% (140)1324

Includes P1 trials using a combination of treatments.


The conduct of P1 trials has increased markedly over the past decade, driven by growing interest in IO.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Peter MacCallum Cancer Centre.


Has not received any funding.


J. Desai: Research grant / Funding (institution): Genentech/Roche; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Novartis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Bionomics; Research grant / Funding (institution): MedImmune; Advisory / Consultancy, Research grant / Funding (institution): BeiGene; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (institution), Advisory / Consultancy: Eisai; Advisory / Consultancy: Ignyta. B. Tran: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astella; Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Janssen-Cilag; Advisory / Consultancy: MSD; Advisory / Consultancy: Novartis; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy: Tolmar; Advisory / Consultancy: Ipsen. All other authors have declared no conflicts of interest.

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