Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

Status:	Recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	3/31/2019
Start Date:	August 2013
End Date:	March 2020
Contact:	Debiopharm International S.A
Email:	clinicaltrials@debiopharm.com
Phone:	+41 21 321 01 11

A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes

This study is primarily designed to assess the safety and the tolerability of Debio1347
(CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of
the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment
does not exist or is not indicated.

The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate
the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally
administered daily to these patients, in order to determine the recommended dose.

The main objective of Part B is to evaluate the safety profile at the recommended dose, in a
larger cohort of these patients.

Inclusion Criteria

- Meets protocol-specified criteria for qualification and contraception

- Is willing and able to remain confined in the study unit for the entire duration of
each treatment period and comply with restrictions related to food, drink and
medications

- Voluntarily consents to participate and provides written informed consent prior to any
protocol-specific procedures

Exclusion Criteria:

- Has history or current use of over-the-counter medications, dietary supplements, or
drugs (including nicotine and alcohol) outside protocol-specified parameters

- Has signs, symptoms or history of any condition that, per protocol or in the opinion
of the investigator, might compromise:

1. the safety or well-being of the participant or study staff

2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding)

3. the analysis of results

We found this trial at

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200