Trial Condition(s):

Neoplasms

STUDY SPONSORSHIP TRANSFERRED - Phase I dose escalation study for BAY 1251152 in patients with advanced cancer

Bayer Identifier:

17496

ClinicalTrials.gov Identifier:

NCT02635672

EudraCT Number:

2014-004808-30

Study Completed

Trial Purpose

DISCLAIMER:
This study was originally conducted and disclosed under Bayer sponsorship; sponsorship was however transferred to a new sponsor while the study was still ongoing. Therefore, this disclosure overview only reflects the study status at the last time that Bayer was responsible for the study – for the latest correct status and details of the study, please refer to the disclosure by the new sponsor under the study’s NCT number on www.ClinicalTrials.gov.

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BAY 1251152 in patients with solid tumors and aggressive non-hodgkin’s lymphoma (NHL).

Inclusion Criteria
-  Male or female patients aged >18 years
 -  Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies
 -  Adequate bone marrow, liver, and renal functions
 -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Exclusion Criteria
-  Active clinically serious infections of > Grade 2
 -  Subjects who have new or progressive brain or meningeal or spinal metastases.
 -  Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to the first dose of study drug
 -  Major surgery, significant trauma, wide-field radiotherapy, or therapy with monoclonal antibodies within 4 weeks before the first dose of study drug
 -  Allogenic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.

Trial Summary

Enrollment Goal
37
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1251152
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

New York, United States, 10032

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28050

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 
Locations

Investigative Site

Aurora, United States, 80010

Status
Completed
 
Locations

Investigative Site

Rochester, United States, 55905

Status
Completed
 

Trial Design