A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

NCT ID: NCT00664326

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2019-04-02

Brief Summary

This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).

Detailed Description

The final analysis of efficacy will be performed after last patient has been treated for at least 6 months. Additional periodic safety and efficacy data reviews will be performed for any patients continuing to receive study drug afterwards.

Conditions

Carcinoma, Renal Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regorafenib (Stivarga, BAY73-4506)

Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Group Type: EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type: DRUG

Patients will be treated with BAY73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.

Interventions

Regorafenib (Stivarga, BAY73-4506)

Patients will be treated with BAY73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients >/= 18 years of age.
• Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma histologically) or cytologically documented.
• Patients must be previously untreated for advanced disease. Prior palliative radiation therapy is allowed if the target lesion(s) are not included within the radiation field and no more than 30% of the bone marrow is irradiated.
• Patients who have at least one uni-dimensional measurable lesion by computed tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
• Patients with "Intermediate" or "Low" risk per the Motzer score.
• Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate bone marrow, renal and hepatic function as assessed by the following laboratory requirements to be conducted within 7 days prior to study drug treatment

Exclusion Criteria

• Patients who have received prior systemic treatment regimens for RCC.
• Uncontrolled/unstable cardiac disease
• Uncontrolled hypertension
• Active clinically serious infections (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2 )
• History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
• Known history or symptomatic metastatic brain or meningeal tumours
• Patients with seizure disorder requiring medication
• Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks of first dose of study.
• Pregnant or breast-feeding patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Los Angeles, California, United States

Houston, Texas, United States

Helsinki, , Finland

Turku, , Finland

Nantes, , France

Paris, , France

Frankfurt am Main, Hesse, Germany

Dresden, Saxony, Germany

Berlin, , Germany

Hamburg, , Germany

Bialystok, , Poland

Lublin, , Poland

Poznan, , Poland

Leicester, Leicestershire, United Kingdom

Bristol, , United Kingdom

Cambridge, , United Kingdom

London, , United Kingdom

Northwood, , United Kingdom

Countries

United States; Finland; France; Germany; Poland; United Kingdom

References

Eisen T, Joensuu H, Nathan PD, Harper PG, Wojtukiewicz MZ, Nicholson S, Bahl A, Tomczak P, Pyrhonen S, Fife K, Bono P, Boxall J, Wagner A, Jeffers M, Lin T, Quinn DI. Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial. Lancet Oncol. 2012 Oct;13(10):1055-62. doi: 10.1016/S1470-2045(12)70364-9. Epub 2012 Sep 6.

Reference Type: RESULT

PMID: 22959186 (View on PubMed)

Related Links

https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer Healthcare products.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2008-000107-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11726

Identifier Type: -

Identifier Source: org_study_id