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A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

Primary Purpose

Carcinoma, Renal Cell

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) + Interferon
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Renal Cell Cancer, Interferon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
  • And/or patients who have discontinued sunitinib treatment at any point due to toxicity
  • Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
  • Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).

Exclusion Criteria:

  • Patient should be excluded if they have unresolved chronic toxicity grade
  • > 1 and related to prior therapy with sunitinib.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sorafenib (Nexavar, BAY43-9006)

Sorafenib (Nexavar, BAY43-9006) + Interferon

Arm Description

Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.

Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.

Outcomes

Primary Outcome Measures

Progression-Free Survival
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.

Secondary Outcome Measures

Response Rate
Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Time to Progression
Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Duration of Response
Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.
Overall Survival
Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

Full Information

First Posted
May 14, 2008
Last Updated
November 24, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00678288
Brief Title
A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.
Official Title
A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Renal Cell Cancer, Interferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib (Nexavar, BAY43-9006)
Arm Type
Experimental
Arm Description
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
Arm Title
Sorafenib (Nexavar, BAY43-9006) + Interferon
Arm Type
Experimental
Arm Description
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006) + Interferon
Intervention Description
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.
Time Frame
From start of treatment of the first subject until 14 months later, assessed every 8 weeks
Secondary Outcome Measure Information:
Title
Response Rate
Description
Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Time Frame
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Title
Time to Progression
Description
Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Time Frame
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Title
Duration of Response
Description
Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.
Time Frame
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Title
Overall Survival
Description
Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time Frame
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment) And/or patients who have discontinued sunitinib treatment at any point due to toxicity Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%). Exclusion Criteria: Patient should be excluded if they have unresolved chronic toxicity grade > 1 and related to prior therapy with sunitinib.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Avignon
ZIP/Postal Code
84000
Country
France
City
Bayonne
ZIP/Postal Code
64100
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Marseille
ZIP/Postal Code
13015
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Nantes
ZIP/Postal Code
44020
Country
France
City
Paris
ZIP/Postal Code
75014
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Reims
ZIP/Postal Code
51100
Country
France
City
Strasbourg
ZIP/Postal Code
67000
Country
France
City
Toulouse
ZIP/Postal Code
31052
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54000
Country
France
City
Cork
Country
Ireland
City
Dublin
ZIP/Postal Code
24
Country
Ireland
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
City
Legnago
State/Province
Verona
ZIP/Postal Code
37045
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Perugia
ZIP/Postal Code
06156
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
City
Wroclaw
ZIP/Postal Code
50 - 556
Country
Poland
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for EudraCT infomation of Bayer Product

Learn more about this trial

A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

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