Phase I Dose Escalation Study for BAY 1251152 in Patients With Advanced Cancer



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:February 10, 2016
End Date:October 3, 2019

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An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY 1251152 in Patients With Advanced Cancer.

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
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