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.
This study has been terminated.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00678288
First received: May 14, 2008
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell |
Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Progression-Free Survival [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]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 Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]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 [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]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 [ Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 16 |
| Study Start Date: | April 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
|
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
|
|
Experimental: Sorafenib (Nexavar, BAY43-9006) + Interferon
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.
|
Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678288
Locations
| Austria | |
| Salzburg, Austria, 5020 | |
| Wien, Austria, 1090 | |
| France | |
| Avignon, France, 84000 | |
| Bayonne, France, 64100 | |
| Bordeaux, France, 33000 | |
| Marseille, France, 13015 | |
| Marseille, France, 13385 | |
| Nantes, France, 44020 | |
| Paris, France, 75014 | |
| Paris, France, 75651 | |
| Reims, France, 51100 | |
| Strasbourg, France, 67000 | |
| Toulouse, France, 31052 | |
| Vandoeuvre Les Nancy, France, 54000 | |
| Ireland | |
| Cork, Ireland | |
| Dublin, Ireland, 24 | |
| Italy | |
| Aviano, Pordenone, Italy, 33081 | |
| Legnago, Verona, Italy, 37045 | |
| Napoli, Italy, 80131 | |
| Pavia, Italy, 27100 | |
| Perugia, Italy, 06156 | |
| Reggio Emilia, Italy, 42100 | |
| Poland | |
| Gdansk, Poland, 80-219 | |
| Lublin, Poland, 20-090 | |
| Warszawa, Poland, 04-141 | |
| Wroclaw, Poland, 50 - 556 | |
| Spain | |
| Barcelona, Spain, 08035 | |
| Madrid, Spain, 28041 | |
| Madrid, Spain, 28046 | |
| Oviedo, Spain, 33006 | |
| Pamplona, Spain, 31008 | |
| Valencia, Spain, 46009 | |
| United Kingdom | |
| Northwood, Middlesex, United Kingdom, HA6 2RN | |
| Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE | |
| London, United Kingdom, SW3 6JJ | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00678288 History of Changes |
| Other Study ID Numbers: | 12782, 2007-005083-28, CONCERT |
| Study First Received: | May 14, 2008 |
| Results First Received: | September 10, 2010 |
| Last Updated: | December 10, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency Poland: Ministry of Health Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Austria: Federal Office for Safety in Health Care Greece: National Organization of Medicines Ireland: Irish Medicines Board |
Keywords provided by Bayer:
|
Renal Cell Cancer Interferon |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Sorafenib Sunitinib |
Interferons Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013