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TerminatedNCT01065623Updated Oct 1, 2014

Clinical Study to Evaluate the Maximum Tolerated Dose of BAY79-4620 Given Every 2 Weeks to Patients With Advanced Solid Tumors

A Phase 1 interventional study of BAY79-4620 in Neoplasms, sponsored by Bayer. Terminated at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Bayer · Phase 1, Interventional, and Treatment

Why this study was terminated
The study was terminated due to safety reasons
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors

02

Conditions studied

  • Neoplasms

Keywords

  • Phase I
  • Dose escalation
  • Immunoconjugate
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The informed consent must be signed before any study specific tests or procedures are done
  • Male or female patients aged >18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Life expectancy of at least 12 weeks
  • Patients with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or patients must have actively refused any treatment which would be regarded standard, and/or if in the judgment of the investigator or his designated associate(s), experimental treatment is clinically and ethically acceptable
  • Radiographically or clinically evaluable tumor
  • Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose

Exclusion criteria

Exclusion Criteria:

  • History of cardiac disease: congestive heart failure (CHF) > NYHA Class II; myocardial infarction within 3 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
  • Uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg, despite optimal medical management
  • Symptomatic metastatic brain or meningeal tumors unless the patient is >6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
  • Patients with severe renal impairment or on dialysis
  • Known human immunodeficiency virus (HIV) infection or patients with an active hepatitis B or C infection necessitating treatment. Patients with chronic hepatitis B or C are eligible
  • Active clinically serious infections of Common Terminology Criteria for Adverse Events Version 3 (CTCAE v3.0) > Grade 2
  • Serious, non-healing wound, ulcer, or bone fracture
  • Major surgery, open biopsy, or significant trauma within 4 weeks prior to the first dose of study drug
  • Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of first dose
  • Radiotherapy to the target lesions within 3 weeks prior to Cycle 1 Day 1 (first dose of study drug). Palliative radiotherapy will be allowed as described in the study protocol. Radiotherapy to the target lesions during study will be regarded as progressive disease
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: BAY79-4620

Interventions

  • DrugBAY79-4620

    1-hour infusion every 14 days. Starting dose will be 0.15 mg/ kg and dose will be escalated dependent on any dose limiting toxicities

06

What researchers measure

Primary outcomes

  1. Adverse Event reporting

    Time frame: Approximately 3 years after initiation of the trial

  2. Pharmacokinetics profile of BAY79-4620

    Time frame: End of cycle 2 (14 days per cycle)

Secondary outcomes

  1. Biomarkers evaluation

    Time frame: Approximately 3 years after initiation of the trial

  2. Tumor response evaluation

    Time frame: Approximately 3 years after initiation of the trial

  3. Immunogenicity evaluation

    Time frame: Approximately 3 years after initiation of the trial

07

Study locations

2 sites
  • Rotterdam, 3075 EA, Netherlands
  • Utrecht, 3584 CX, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01065623
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Feb 9, 2010
Start date
Apr 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Oct 1, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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