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Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

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Bayer

Status and phase

Completed
Phase 1

Conditions

Neoplasms

Treatments

Drug: Regorafenib (Stivarga, BAY73-4506)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female Chinese subjects >/- 18 years
  • Advanced, histologically or cytologically confirmed solid tumors
  • Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;
  • Adequate bone marrow, liver and renal function
  • Life expectancy of at least 3 months

Exclusion criteria

  • Unstable/uncontrolled cardiac disease
  • History of arterial or venous thrombotic or embolic events
  • Malabsorption condition
  • Severe renal impairment; persistent proteinuria >/= Grade 3
  • Symptomatic metastatic brain or meningeal tumors
  • Clinically significant bleeding >/=Grade 3 within 30 days before start of study medication.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Regorafenib
Experimental group
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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