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First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT01881217
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors

Condition or disease Intervention/treatment Phase
Neoplasms Drug: BAY1179470 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY 1179470 in Subjects With Advanced, Refractory Solid Tumors.
Actual Study Start Date : June 28, 2013
Actual Primary Completion Date : March 18, 2016
Actual Study Completion Date : August 16, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: BAY1179470 (Dose escalation)
BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
 Drug: BAY1179470
BAY1179470 will be administered as a 1-hour intravenous infusion.
Experimental: BAY1179470 (additional)
Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
 Drug: BAY1179470
BAY1179470 will be administered as a 1-hour intravenous infusion.
Experimental: BAY1179470 (expansion)
Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
 Drug: BAY1179470
BAY1179470 will be administered as a 1-hour intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 2 years ]
  2. Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470 [ Time Frame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days ]
  3. Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration [ Time Frame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days ]

Secondary Outcome Measures :
  1. Tumor response [ Time Frame: Every 42 days ]
    Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.

  2. Biomarker (plasma) [ Time Frame: Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days ]
  3. Biomarker (biopsy) [ Time Frame: Cycle 1: pre-dose and Day 8; cycle 1 is 21 days ]
    Additional cohort only

  4. Immunogenicity [ Time Frame: Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days ]
    Analyzed for anti-BAY 1179470 antibodies


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
  • Adequate bone marrow, liver, and renal function.

For subjects in the additional cohort:

  • Subjects with advanced, histologically or cytologically confirmed gastric cancer.
  • At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed

Exclusion Criteria:

  • History of severe allergic reactions to monoclonal antibody therapy
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
  • Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
Contacts and Locations
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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): NCT01881217


Locations
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Japan
Kashiwa, Chiba, Japan, 277-8577
Kita-Adachigun, Saitama, Japan, 362-0806
Chuo-ku, Tokyo, Japan, 104-0045
Koto-ku, Tokyo, Japan, 135-8550
Fukuoka, Japan, 811-1395
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Singapore
Singapore, Singapore, 119074
Singapore, Singapore, 169610
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01881217    
Other Study ID Numbers: 16182
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Keywords provided by Bayer:
Phase I
Dose escalation
Advanced, refractory solid tumors
FGFR2