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Our clinical studies

We are committed to make our Clinical trials Information and Results accessible and transparent while maintaining participants privacy.

 

Clinical studies

This site provides information on both ongoing and completed clinical trials sponsored by Pierre Fabre since 2004. Real-world evidence studies which began after 01 January 2020 are also accessible.

 

Total studies

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Current studies

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Oncology

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Dermatology

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Rare diseases

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Title Therapeutic area Phase Status Start date (Planned) End date

Study of FIH of STX-241 in locally advanced or metastatic NSCLC resistant to EGFR TKIs (STX-241FIH)

Oncology Phase I / II Active 17 September 2024 July 2030

A prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intra-amniotic ER004 as a prenatal treatment for male subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED)

Dermatology Phase II Recruiting 26 April 2022 January 2029

Advanced breast cancer patients treated with oral vinorelbine: a prospective and retrospective, observational study – VINOREAL

Oncology RWE Recruiting 03 May 2023 30 June 2028

Encorafenib in combination with Cetuximab in BRAFV600E–Mutated Metastatic Colorectal Cancer: A European pooled analysis of observational studies.

Oncology RWE Completed 01 August 2024 31 December 2026

Natural History and Disease Burden of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED): An Observational, Multicentre, International Study

Dermatology RWE Active not recruiting July 2023 September 2026

Multicenter, Open-label, Phase II Study with a Safety Lead-in part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAFV600E mutated Chinese Patients with Metastatic Non-Small Cell Lung Cancer who are BRAF- and MEK inhibitor treatment-naïve

Oncology Phase II Active not recruiting 27 May 2024 April 2026

Multicentre, multi-country, prospective, observational, post-authorisation safety study to describe the incidence of discontinuation due to diarrhoea within the first 3 months of treatment with neratinib, in adult breast cancer patients treated in extended adjuvant in a real-world setting: the NERLYFE study..

Oncology RWE Active not recruiting 08 May 2022 January 2026

Study of the combination of Binimetinib and Encorafenib in adolescent patients with unresectable or Metastatic BRAF V600-mutant Melanoma

Oncology Phase I Active not recruiting 03 August 2020 05 September 2025

An observational study describing diagnosis and treatment patterns in adults with metastatic non-small cell lung cancer with BRAF V600E mutation in clinical practice, to assess treatment effectiveness and quality of life.

Oncology RWE Completed 23 June 2022 07 January 2025

Adjuvant encorafenib & binimetinib vs. placebo in resected stage II BRAF V600E/K mutated melanoma: a randomized triple-blind Phase III Study in collaboration with the EORTC Melanoma Group.

Oncology Phase III Completed 18 May 2022 19 November 2024

Encorafenib in combination with Cetuximab in BRAFV600E–Mutated Metastatic Colorectal Cancer: A European pooled analysis of observational studies

Oncology RWE Completed 01 January 2020 31 October 2024

Neratinib in patients with HER2+ breast cancer: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Switzerland, Germany and Austria. rEal-LifE pAN-HER-blOckade with neRatinib: ELEANOR

Oncology RWE Completed 02 July 2020 05 September 2024

A multicenter, randomized, open-label, 2-arm, Phase II trial with a safety lead-in phase evaluating the combination of encorafenib and cetuximab versus irinotecan/cetuximab or infusional 5-fluorouracil (5-FU)/folinic acid (FA)/irinotecan (FOLFIRI)/cetuximab in Chinese patients with BRAFV600E mutant metastatic colorectal cancer.

Oncology Phase II Active 02 September 2021 September 2024

A 6-months prospective, observational study to evaluate the quality of life of patients treated with phytotherapy or alpha-blockers for benign prostatic hyperplasia.

Urology RWE Completed June 2022 29 July 2024

A prospective non interventional study on targeted therapy for patients with unresectable or metastatic BRAFV600E mutant melanoma (TAVIE-Skin)

Oncology RWE Completed February 2021 29 March 2024

Phase I dose escalation and dose expansion, international, multicenter study of W0180 as single agent and in combination with pembrolizumab (anti-PD-1) in adult participants with locally advanced or metastatic solid tumors.

Oncology Phase I Completed 08 September 2020 09 October 2023

A Randomized, single-center, open-label, single dose, two-period, crossover study to investigate the relative bioavailability of Binimetinib 3 x15 mg and 45 mg tablets in healthy participants

Oncology Phase I Completed 03 September 2021 18 June 2023

Phase 2, open-label, single arm, multicenter study of Encorafenib, Binimetinib plus Cetuximab in subjects with previously untreated BRAFV600E -mutant metastatic colorectal cancer

Oncology Phase II Completed 29 June 2020 11 April 2023

An open label, multicentre, phase I study to evaluate the impact of moderate and severe hepatic impairments on the pharmacokinetics and safety of encorafenib in combination with binimetinib in adult patients with unresectable or metastatic BRAF V600-mutant solid tumors.

Oncology Phase I Completed 30 May 2022 10 January 2023

A randomized, single-center, open-label, single dose, two-period, crossover pivotal bioequivalence study comparing binimetinib 3 x 15 mg and 45 mg tablets in healthy participants

Oncology Phase I Completed 31 August 2022 December 2022

Get access to Partner's pivotal studies supporting our authorized drugs in Europe

Results from pivotal studies conducted by our partners and supporting a marketing approval for whom Pierre Fabre is the holder in Europe are shared below:

 

Melanoma

SPONSOR: PFIZER

Breast cancer 

SPONSOR: PUMA BIOTECHNOLOGY

Colorectal cancer

SPONSOR: PFIZER

Post-transplantation lymphoproliferative disease EBV+

SPONSOR: ATARA