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Completed Phase 1 Interventional Results available

Continuous Dosing of BAY73-4506 in Patients With Advanced Malignancies

ClinicalTrials.gov ID: NCT01117623

Public ClinicalTrials.gov record NCT01117623. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 27, 2026, 2:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open Label, Phase I Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Biomarker Status of BAY73-4506 in Patients With Advanced Malignancies

Study identification

NCT ID
NCT01117623
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Bayer
Industry
Enrollment
86 participants

Conditions and interventions

Conditions

Interventions

  • Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg Drug
  • Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg Drug
  • Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg Drug
  • Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg Drug
  • Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg Drug
  • HCC Child-Pugh A expansion cohort: Regorafenib 100 mg Drug
  • HCC Child-Pugh B expansion cohort: Regorafenib 100 mg Drug
  • NSCLC expansion cohort: Regorafenib 100 mg Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2007
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013
Last update posted
Nov 17, 2015

2007 – 2013

United States locations

U.S. sites
5
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
Not listed Los Angeles California 90095
Not listed Aurora Colorado 80045
Not listed Houston Texas 77030
Not listed San Antonio Texas 78229-3307
Not listed San Antonio Texas 78229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01117623, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 17, 2015 · Synced Jun 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01117623 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →