Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635672
Recruitment Status : Active, not recruiting
First Posted : December 21, 2015
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Neoplasms Drug: BAY 1251152 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose escalation of BAY 1251152 / Arm 1
Investigating BAY 1251152 in a dose escalation cohort in patients with solid tumors and aggressive NHL
Drug: BAY 1251152
The starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles.




Primary Outcome Measures :
  1. Incidence of DLT (Dose limit toxicity) of BAY1251152 [ Time Frame: End of Cycle 1 / Day 21 ]
  2. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1251152 [ Time Frame: Cycle1 / Day 1 (C1D1), C1D2,C1D3, C1D4, C1D8C1D15, C1D16,C1D17,C1D18,C2D1 ]
  3. Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  4. AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of BAY1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  5. Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of BAY1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  6. AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of BAY1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  7. Recommended phase 2 dose (RP2D) of BAY 1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  8. Number of participants with adverse events as a measure safety and tolarability [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635672


Locations
Layout table for location information
United States, Colorado
Aurora, Colorado, United States, 80010
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
New York, New York, United States, 10032
Spain
Madrid, Spain, 28040
Madrid, Spain, 28050
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02635672    
Other Study ID Numbers: 17496
2014-004808-30 ( EudraCT Number )
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Solid tumors
Aggressive non-hodgkin's lymphoma (NHL)