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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Aurora, United States, 80010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Incidence of DLT (Dose limit toxicity) of BAY1251152Timeframe: End of Cycle 1 / Day 21
- Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1251152Timeframe: Cycle1 / Day 1 (C1D1), C1D2,C1D3, C1D4, C1D8C1D15, C1D16,C1D17,C1D18,C2D1
- Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1251152Timeframe: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
- AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of BAY1251152Timeframe: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
- Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of BAY1251152Timeframe: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
- AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of BAY1251152Timeframe: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
- Recommended phase 2 dose (RP2D) of BAY 1251152Timeframe: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
- Number of participants with adverse events as a measure safety and tolarabilityTimeframe: Up to 3 years
Secondary Outcome
- Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Cheson’s criteria for aggressive NHL)Timeframe: Up to 3 years
Additional Information
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