Clinical trial NCT00492297: 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: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Best Response
timeFrame: during or within 30 days after active therapy
Secondary outcomes:
measure: Progression-free Survival
timeFrame: from start of treatment until progression or death before progression (median 259 days)
measure: Percentage of Subjects With Progression-free Survival at Specific Time-points
timeFrame: from start of treatment until progression or death before progression after 3, 6 and 12 months
measure: Overall Survival
timeFrame: from start of treatment until death (median 259 days)
measure: Duration of Response
timeFrame: from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)
measure: Duration of Complete Response
timeFrame: from confirmed CR until PD (median 259 days)
measure: Duration of Partial Response
timeFrame: from confirmed PR until PD (median 259 days)
measure: Disease Control (DC)
timeFrame: after start of treatment, at 6 months and 12 months
measure: Duration of Stable Disease
timeFrame: from start of therapy to PD, only in non-responders (median 259 days)
measure: Time to Response
timeFrame: start of therapy to confirmed CR or PR (median 259 days)
measure: Time to Progression
timeFrame: From start of treatment until progression (median 259 days)
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Lyon Cedex
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Southampton
country: United Kingdom
state: Hampshire
city: Northwood
country: United Kingdom
state: Middlesex
city: Sutton
country: United Kingdom
state: Surrey
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.