Terminated/Withdrawn

Medical Oncology

Bayer Identifier:

16897

ClinicalTrials.gov Identifier:

NCT02368951

EudraCT Number:

Not Available

EU CT Number:

Not Available

Phase I, dose-escalation trial of BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

Trial purpose

To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

Key Participants Requirements

Sex

Both

Age

18 - N/A

Inclusion Criteria
- All subjects must be >/= 18 years at the first screening examination / visit
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Subjects with advanced, histologically or cytologically confirmed solid tumors described to express fibroblast growth factor receptor 2 (FGFR2) that are refractory to any standard therapy
- For maximum tolerated dose (MTD) Dose Expansion: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer who had undergone within 4 lines of systemic anti-cancer treatment and not eligible for standard therapy anymore.
- Subjects need to have evaluable disease (measurable or not measurable).
- Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment
Exclusion Criteria
- History of allergic reactions to monoclonal antibody therapy (or excipients in the formulation)
- Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
- Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
- History of symptomatic metastatic brain or meningeal tumors unless the subject is longer than 3 months from the end of definitive therapy before the first dose of the investigational drug and has clinically or radiologically no evidence of tumor growth.
- History of clinically significant cardiac disease
- Congenital coagulation abnormalities
- Subjects who are pregnant or are breast-feeding

Trial summary

Enrollment Goal

Trial Dates

March 2015 - July 2016

Phase

Phase 1

Could I Receive a placebo

Products

Aprutumab Ixadotin (BAY1187982)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Seoul, 138-736, Korea, Republic Of
Completed		Chicago, 60611, United States
Completed		Nashville, 37232, United States
Completed		Houston, 77030, United States
Terminated		Seoul, 03080, Korea, Republic Of
Terminated		Singapore, 169610, Singapore
Terminated		San Francisco, 94115, United States
Terminated		Santa Monica, 90404-1200, United States
Terminated		New Haven, 06520, United States
Terminated		St. Louis, 63110, United States
Terminated		New York, 10016, United States
Terminated		Baltimore, 21231, United States
Terminated		Seattle, 98109-1023, United States

Primary Outcome

Maximum tolerated dose(MTD)
The MTD is defined as the maximum dose at which the incidence of DLTs during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalation
Time Frame:
Up to 2 years
Safety Issue:
Yes
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame:
Up to 2 years
Safety Issue:
Yes
Number of subjects with serious adverse events as a measure of safety and tolerability
Time Frame:
Up to 2 years
Safety Issue:
Yes

Secondary Outcome

Cmax (maximum observed drug concentration in measured matrix after single dose administration)
Time Frame:
Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
Safety Issue:
No
AUC(0-tlast) AUC from time 0 to the last data point >LLOQ
Time Frame:
Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
Safety Issue:
No
AUC)0-504 (AUC from zero to 504 hours post infusion)
Time Frame:
Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
Safety Issue:
No
AUC (area under the concentration vs. time curve from zero to infinity after single (first)
Time Frame:
Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
Safety Issue:
No
Cmax,md (maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval)
Time Frame:
Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
Safety Issue:
No
AUC(0-tlast)md (AUC from time 0 to the last data point >LLOQ after multiple dosing)
Time Frame:
Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
Safety Issue:
No
AUC(0-504)md
Time Frame:
Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
Safety Issue:
No
FGFR2 levels in tumor tissue sample
Time Frame:
Screening
Safety Issue:
No
CK18 levels in tumor tissue sample
Time Frame:
Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion.
Safety Issue:
No
Nucleosome level in plasma
Time Frame:
Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion.
Safety Issue:
No
Development of anti-drug antibodies (ADAs) in plasma as an indicator of immunogenicity
Time Frame:
Cycle 1: Day 1: before infusion (pre-dose), Day 8
Safety Issue:
No
Tumor response
Time Frame:
Screening, Day 15 (± 7 days) of Cycle 2 and every even subsequent Cycle (i.e. Cycles 2, 4, 6, 8, etc.)
Safety Issue:
No

Trial design

An open-label,Phase I, dose-escalation trial to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetic, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express FGFR2.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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