First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-28

Study Completion Date

2016-08-16

Brief Summary

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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

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BAY1179470 (Dose escalation)

BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Group Type EXPERIMENTAL

BAY1179470

Intervention Type DRUG

BAY1179470 will be administered as a 1-hour intravenous infusion.

BAY1179470 (additional)

Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Group Type EXPERIMENTAL

BAY1179470

Intervention Type DRUG

BAY1179470 will be administered as a 1-hour intravenous infusion.

BAY1179470 (expansion)

Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Group Type EXPERIMENTAL

BAY1179470

Intervention Type DRUG

BAY1179470 will be administered as a 1-hour intravenous infusion.

Interventions

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BAY1179470

BAY1179470 will be administered as a 1-hour intravenous infusion.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No