A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00492297
First received: June 26, 2007
Last updated: February 28, 2012
Last verified: February 2012
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Tracking Information | |||||
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First Received Date ICMJE | June 26, 2007 | ||||
Last Updated Date | February 28, 2012 | ||||
Start Date ICMJE | April 2005 | ||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Best Response [ Time Frame: during or within 30 days after active therapy ] [ Designated as safety issue: No ] Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions. |
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Original Primary Outcome Measures ICMJE |
Evaluate overall tumour response rate including CR and PR using RECIST criteria [ Time Frame: Treatment period ] | ||||
Change History | Complete list of historical versions of study NCT00492297 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Progression-free survival (PFS), overall survival, evaluate safety and toxicity profile of the combination, explore potential biomarkers linked to response [ Time Frame: Treatment period ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma | ||||
Official Title ICMJE | A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma. | ||||
Brief Summary | The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma. |
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Detailed Description | Issues on "Safety" outcomes are addressed in the Adverse Event section. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | ||||
Intervention ICMJE | Drug: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)
Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid) |
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Study Arm (s) | Experimental: Sorafenib + Dacarbazine
Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC) |
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Publications * | T Eisen et al: Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. British Journal of Cancer (2011) 105, 353 - 359, 2011 | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 83 | ||||
Completion Date | June 2008 | ||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | France, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00492297 | ||||
Other Study ID Numbers ICMJE | 11538, EudraCT: 2004-000725-30 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Therapeutic Area Head, Bayer HealthCare AG | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bayer | ||||
Verification Date | February 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |