stop_circleTerminated/Withdrawn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
  • - 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
  • - 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
20
Trial Dates
March 2015 - July 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Aprutumab Ixadotin (BAY1187982)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of subjects with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of subjects with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.