Clinical trial NCT01881217: First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
Official title: An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY 1179470 in Subjects With Advanced, Refractory Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Phase I
Dose escalation
Advanced, refractory solid tumors
FGFR2
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors


Eligibility criteria: Inclusion Criteria:

* Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
* Adequate bone marrow, liver, and renal function.

For subjects in the additional cohort:

* Subjects with advanced, histologically or cytologically confirmed gastric cancer.
* At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed

Exclusion Criteria:

* History of severe allergic reactions to monoclonal antibody therapy
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 90 mmHg, despite optimal medical management
* Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study

Primary outcomes:
measure: Number of participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 2 years
measure: Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470
timeFrame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
measure: Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration
timeFrame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Secondary outcomes:
measure: Tumor response
timeFrame: Every 42 days
measure: Biomarker (plasma)
timeFrame: Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days
measure: Biomarker (biopsy)
timeFrame: Cycle 1: pre-dose and Day 8; cycle 1 is 21 days
measure: Immunogenicity
timeFrame: Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days
Other outcomes:
Locations:
city: Kashiwa
country: Japan
state: Chiba
city: Kita-Adachigun
country: Japan
state: Saitama
city: Chuo-ku
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Seoul
country: Korea, Republic of
city: Singapore
country: Singapore
city: Singapore
country: Singapore
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: