stop_circleTerminated/Withdrawn

Medical Oncology

Phase I dose escalation and expansion of oral BAY 1143269 in combination with intravenous docetaxel

Trial purpose

Determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics (PK), and/or recommended Phase II dose (RP2D) of oral BAY 1143269 given alone or in combination with intravenous (IV) docetaxel in subjects with advanced solid tumors.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
15
Trial Dates
June 2015 - April 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1143269
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Santa Monica, 90403, United States
Completed
San Antonio, 78229, United States
Completed
Dallas, 75246, United States
Completed
Sutton, SM2 5PT, United Kingdom
Completed
Houston, 77030, United States

Primary Outcome

  • Maximum Tolerated Dose (MTD) of Oral BAY1143269 Alone and in Combination With Intravenous Docetaxel
    The MTD of oral BAY1143269 given alone was defined as the maximum dose at which the predicted incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 30 percent (%).
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum Observed Drug Concentration (Cmax) in Plasma After Single and Multiple Dose Administration of BAY1143269
    Maximum observed concentration of BAY1143269 in plasma after single dose and multiple dose administration was measured.
    date_rangeTime Frame:
    Cycle 1, 2 Day 1: Pre-dose to 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    Yes
  • Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] After Single and Multiple Dose Administration of BAY1143269
    Area under the concentration-time curve from zero to 24 hours after single dose and multiple dose administration of BAY1143269 in plasma was measured.
    date_rangeTime Frame:
    Cycle 1, 2 Day 1: Pre-dose to 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Tumor response
    Tumor response was assessed by Response Evaluation Criteria in Solid Tumors(RECIST V1.1). Evaluation of target lesions included CR(Disappearance of all target lesions),PR(at least a 30% decrease in sum of diameters of target lesions),PD:at least a 20% increase in sum of diameters of target lesions, taking smallest sum recorded as reference since treatment started or appearance of one or more new lesions) and Stable disease(SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).Evaluation of non-target lesions included CR(disappearance of all non-target lesions and normalization of tumor marker level),Non-CR/PD(Persistence of 1 or more non target lesions and/or maintenance of tumor marker level above normal limits) and PD(Appearance of 1 or more new lesions and/or unequivocal progression of existing non target lesions).
    date_rangeTime Frame:
    Baseline; end of Cycle 2
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label, non-randomized, multicenter Phase I study to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of oral MKNK1 inhibitor BAY 1143269 given alone or in combination with intravenous docetaxel in subjects with advanced solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Sequential Assignment
Trial Arms
4