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

NCT ID: NCT00492297

Last Updated: 2014-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-07-31

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.

Detailed Description

Issues on "Safety" outcomes are addressed in the Adverse Event section.

Conditions

Melanoma

Study Design

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

Study Groups

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)

Group Type: EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable
• Age >= 18 years
• Subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan as per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler
• Subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria

• Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted)
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry
• (Active coronary artery disease or ischemia (myocardial infarction more than 6 months prior to study entry is allowed)
• Uncontrolled hypertension (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0)
• Active, clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
• Subjects with seizure disorder requiring medication are excluded
• History of or suspected Human Immunodeficiency Virus (HIV) infection, or chronic hepatitis B or C
• Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
• Pregnant or breast-feeding subjects

• 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

Bordeaux, , France

Lyon, , France

Toulouse, , France

Villejuif, , France

Cambridge, Cambridgeshire, United Kingdom

Southampton, Hampshire, United Kingdom

London, London, United Kingdom

London, London, United Kingdom

London, London, United Kingdom

Manchester, Manchester, United Kingdom

Northwood, Middlesex, United Kingdom

Sutton, Surrey, United Kingdom

Countries

France; United Kingdom

References

Eisen T, Marais R, Affolter A, Lorigan P, Robert C, Corrie P, Ottensmeier C, Chevreau C, Chao D, Nathan PD, Jouary T, Harries M, Negrier S, Montegriffo E, Ahmad T, Gibbens I, James MG, Strauss UP, Prendergast S, Gore ME. Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. Br J Cancer. 2011 Jul 26;105(3):353-9. doi: 10.1038/bjc.2011.257. Epub 2011 Jul 12.

Reference Type: RESULT

PMID: 21750549 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu

Click here and search for information of Bayer products for Europe

Other Identifiers

2004-000725-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11538

Identifier Type: -

Identifier Source: org_study_id