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

Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881217
• Other study ID #: 16182
• Status: Completed
• Phase: Phase 1
• First received: June 17, 2013
• Last updated: September 13, 2017
• Start date: June 28, 2013
• Est. completion date: August 16, 2016

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 16, 2016
• Est. primary completion date: March 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• BAY1179470
BAY1179470 will be administered as a 1-hour intravenous infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events as a Measure of Safety and Tolerability		Up to 2 years
Primary	Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470		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
Primary	Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration		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	Tumor response	Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.	Every 42 days
Secondary	Biomarker (plasma)		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
Secondary	Biomarker (biopsy)	Additional cohort only	Cycle 1: pre-dose and Day 8; cycle 1 is 21 days
Secondary	Immunogenicity	Analyzed for anti-BAY 1179470 antibodies	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

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