stop_circleTerminated/Withdrawn

neoplasms

BAY1238097, first in man

Trial purpose

This is the first study where BAY1238097 is given to humans. Impact of the study is to evaluate if patients with advanced cancer show clinical benefit under the treatment with BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all comers) and lymphoma will receive the study drug treatment in an escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be determined

After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be enrolled
A separate escalation scheme will be applied to patients with leucemias, and at the maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled.
the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters of BAY1238097 and tumor response to the treatment.
BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the patient decides to withdraw from the treatment.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
8
Trial Dates
March 2015 - January 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1238097
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Completed
Churchill HospitalOxford, OX3 7LJ, United Kingdom
Completed
Institut Gustave Roussy - VillejuifVILLEJUIF CEDEX, 94805, France
Terminated
HUS, Meilahden sairaalaHUS, 00029, Finland
Terminated
Istituto Oncologico della Svizzera ItalianaBellinzona, 6500, Switzerland
Terminated
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany

Primary Outcome

  • incidence of DLT(dose-limiting toxicities)
    date_rangeTime Frame:
    Cycle 1(the first 21 days )
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Tumor response evaluation based on the response criteria as applicable
    date_rangeTime Frame:
    up to 6 months.
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label, non-randomized, multicenter Phase I dose escalation study to characterize safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY 1238097 in subjects with advanced malignancies
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1