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Completed

NCT Number: NCT01881217

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

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

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kashiwa, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1179470

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2013
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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