NCT00664326

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2

Geographic Reach
6 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

April 30, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 28, 2012

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

April 17, 2008

Results QC Date

October 28, 2012

Last Update Submit

January 27, 2021

Conditions

Carcinoma, Renal Cell

Keywords

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Objective Tumor Response

    Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.

    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

  • Tumor Response

    Tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\], Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\], Stable Disease \[SD, steady state of disease\], or Progressive Disease \[PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions\]) observed during trial period assessed according to the RECIST committee.

    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

Secondary Outcomes (6)

  • Disease Control

    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

  • Overall Survival

    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).

  • Progression-free Survival (PFS)

    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

  • Time to Progression (TTP)

    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

  • Duration of Response

    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

  • +1 more secondary outcomes

Other Outcomes (8)

  • Objective Tumor Response (Update)

    From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks

  • Tumor Response (Update)

    From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks

  • Disease Control (Update)

    From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks

  • +5 more other outcomes

Study Arms (1)

Regorafenib (Stivarga, BAY73-4506)

EXPERIMENTAL

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

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506)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.

Regorafenib (Stivarga, BAY73-4506)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Helsinki, 00290, Finland

Location

Unknown Facility

Turku, FIN-20521, Finland

Location

Unknown Facility

Nantes, 44020, France

Location

Unknown Facility

Paris, 75014, France

Location

Unknown Facility

Frankfurt am Main, Hesse, 60596, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Berlin, 10967, Germany

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Unknown Facility

Bialystok, 15-027, Poland

Location

Unknown Facility

Lublin, 20-090, Poland

Location

Unknown Facility

Poznan, 60-569, Poland

Location

Unknown Facility

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Unknown Facility

Bristol, BS2 8ED, United Kingdom

Location

Unknown Facility

Cambridge, CB2 0QQ, United Kingdom

Location

Unknown Facility

London, SE1 9RT, United Kingdom

Location

Unknown Facility

Northwood, HA6 2RN, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22959186RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

regorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Therapeutic Area Head
Organization
BAYER
clinical-trials-contact@bayerhealthcare.com

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 22, 2008

Study Start

April 30, 2008

Primary Completion

May 31, 2009

Study Completion

April 2, 2019

Last Updated

January 29, 2021

Results First Posted

November 28, 2012

Record last verified: 2021-01

Locations

DE(4)GB(5)PL(3)US(2)FI(2)FR(2)