NCT01881217

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2013

Typical duration for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

June 28, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2016

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

2.7 years

First QC Date

June 17, 2013

Last Update Submit

September 13, 2017

Conditions

Neoplasms

Keywords

Phase IDose escalationAdvanced, refractory solid tumorsFGFR2

Outcome Measures

Primary Outcomes (3)

  • Number of participants with Adverse Events as a Measure of Safety and Tolerability

    Up to 2 years

  • Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470

    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

  • Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration

    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 (4)

  • Tumor response

    Every 42 days

  • Biomarker (plasma)

    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

  • Biomarker (biopsy)

    Cycle 1: pre-dose and Day 8; cycle 1 is 21 days

  • Immunogenicity

    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

Study Arms (3)

BAY1179470 (Dose escalation)

EXPERIMENTAL

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

Drug: BAY1179470

BAY1179470 (additional)

EXPERIMENTAL

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

Drug: BAY1179470

BAY1179470 (expansion)

EXPERIMENTAL

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

Drug: BAY1179470

Interventions

BAY1179470DRUG

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

BAY1179470 (Dose escalation)BAY1179470 (additional)BAY1179470 (expansion)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

Unknown Facility

Kita-Adachigun, Saitama, 362-0806, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0045, Japan

Location

Unknown Facility

Koto-ku, Tokyo, 135-8550, Japan

Location

Unknown Facility

Fukuoka, 811-1395, Japan

Location

Unknown Facility

Singapore, 119074, Singapore

Location

Unknown Facility

Singapore, 169610, Singapore

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

June 28, 2013

Primary Completion

March 18, 2016

Study Completion

August 16, 2016

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

KR(1)SG(2)JP(5)