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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

Tracking Information
First Submitted Date  ICMJE December 17, 2015
First Posted Date  ICMJE December 21, 2015
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE February 10, 2016
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Incidence of DLT (Dose limit toxicity) of BAY1251152 [ Time Frame: End of Cycle 1 / Day 21 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Recommended phase 2 dose (RP2D) of BAY 1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  • Number of participants with adverse events as a measure safety and tolarability [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
  • Incidence of DLT (Dose limit toxicity) of BAY1251152 [ Time Frame: End of Cycle 1 / Day 21 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Recommended phase 2 dose (RP2D) of BAY 1251152 [ Time Frame: C1D1, C1D2,C1D3, C1D4, C1D8,C1D15, C1D16,C1D17,C1D18,C2D1 ]
  • Number of participants with adverse events as a measure safety and tolerability [ Time Frame: Up to 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Dose Escalation Study for BAY 1251152 in Patients With Advanced Cancer
Official Title  ICMJE 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.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Dose escalation of BAY 1251152 / Arm 1
Investigating BAY 1251152 in a dose escalation cohort in patients with solid tumors and aggressive NHL
Intervention: Drug: BAY 1251152
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 16, 2020)
37
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2015)
50
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02635672
Other Study ID Numbers  ICMJE 17496
2014-004808-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP