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:1/31/2019
Start Date:August 2013
End Date:December 2019
Contact:Debiopharm International S.A
Email:clinicaltrials@debiopharm.com
Phone:+41 21 321 01 11

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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
5
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-8033
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6261
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-794-1226
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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1275 York Avenue
New York, New York 10065
Phone: 646-422-4362
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Seoul,
Phone: +82 2 2072 2390
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