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 |
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).
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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