Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)

Status:	Active, not recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/27/2019
Start Date:	December 30, 2013
End Date:	September 27, 2019

An Open Label, Non-randomized, Phase I Dose Escalation Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY1163877 in Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors

- This is the first study where BAY1163877 is given to humans. Impact of the study is to
evaluate if patients with advanced solid cancers show advanced clinical benefit under
the treatment with the pan FGFR inhibitor. Patients (all comers) will receive the study
drug treatment in a dose-escalation scheme (no placebo group) to determine the safety,
tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative
bioavailability of liquid service formulation and tablets will be determined.

- After the MTD is defined patients with solid tumors (all comers), lung cancer (lung
adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder
cancer will be enrolled according to their FGFR expression profile (biomarker
stratification).

- The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic
parameters and tumor response of BAY1163877.

- BAY1163877 will be given twice daily as oral application. Treatment will be stopped if
the tumor continues to grow, if side effects, which the patient cannot tolerate, occur
or if the patient decides to exit treatment.

Inclusion Criteria:

- For dose escalation: Subjects with any type of solid tumor (all comer) will be
eligible for dose escalation and dose expansion at MTD in Part 1; Subjects enrolled
for dose expansion (MTD expansion cohort "all comer") will be stratified according to
high fibroblast growth factor receptor (FGFR) expression levels / FGFR mutation using
archival or fresh tumor biopsy material

- For expansion cohorts: Subjects will be eligible for Part 2 only if they have
histological or cytological confirmed squamous non-small cell lung cancer (sqNSCLC),
lung adenocarcinoma, head and neck cancer or bladder cancer (BC). All subjects in Part
2 will be stratified according to high FGFR expression levels FGFR mutation using
archival or fresh tumor biopsy specimen. BC subjects with low overall FGFR expression
levels can be included if activating FGFR3(FGFR tyrosine kinases3) mutations are
confirmed

- Subjects must have measurable disease (Response evaluation criteria in solid tumors
(RECIST 1.1))

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

- Bone marrow, liver and renal functions as assessed by adequate laboratory methods to
be conducted within 7 days prior to starting study Treatment

- Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 according to the modified diet in
renal disease (MDRD) abbreviated formula

Exclusion Criteria:

- Previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase
inhibitors or FGFR-specific antibodies)

- Concomitant therapies that cannot be discontinued or switched to a different
medication prior to study entry that are known to increase serum phosphate levels are
not permitted within 4 weeks prior to start of study treatment)

- Anticancer chemotherapy or immunotherapy during the study or within 5-halflives prior
to start of study treatment. Mitomycin C, nitrosoureas or monoclonal antibodies with
anticancer activity (e.g. bevacizumab or cetuximab etc.) should not be given within 6
weeks before starting to receive study treatment or within 6 weeks of pre-treatment
biopsy for biomarker (p-ERK1/2) studies

We found this trial at

sites

Clinical Trial Facility in Besancon

16 Route de Gray
Besancon, 25030

from

Besancon,