check_circleStudy Completed

Neoplasms

Bayer Identifier:

17496

ClinicalTrials.gov Identifier:

NCT02635672

EudraCT Number:

2014-004808-30

EU CT Number:

Not Available
STUDY SPONSORSHIP TRANSFERRED - Phase I dose escalation study for BAY 1251152 in patients with advanced cancer

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
February 2016 - February 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1251152
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
New York, 10032, United States
Completed
Madrid, 28050, Spain
Completed
Madrid, 28040, Spain
Completed
Aurora, 80010, United States
Completed
Rochester, 55905, United States
Withdrawn
Scottsdale, 85259-5404, United States
Withdrawn
Jacksonville, 32224, United States
Withdrawn
New York, 10019, United States
Withdrawn
Barcelona, 08035, Spain
Withdrawn
Badalona, 08916, Spain
Withdrawn
Nashville, 37232, United States
Withdrawn
Eugene, 97401, United States

Primary Outcome

  • Incidence of DLT (Dose limit toxicity) of BAY1251152
    date_rangeTime Frame:
    End of Cycle 1 / Day 21
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1251152
    date_rangeTime Frame:
    Cycle1 / Day 1 (C1D1), C1D2,C1D3, C1D4, C1D8C1D15, C1D16,C1D17,C1D18,C2D1
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1251152
    date_rangeTime Frame:
    C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
    enhanced_encryption
    Safety Issue:
    No
  • AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of BAY1251152
    date_rangeTime Frame:
    C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
    enhanced_encryption
    Safety Issue:
    No
  • Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of BAY1251152
    date_rangeTime Frame:
    C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
    enhanced_encryption
    Safety Issue:
    No
  • AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of BAY1251152
    date_rangeTime Frame:
    C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
    enhanced_encryption
    Safety Issue:
    No
  • Recommended phase 2 dose (RP2D) of BAY 1251152
    date_rangeTime Frame:
    C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure safety and tolarability
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes

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)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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