Study Completed

Melanoma

Bayer Identifier:

11538

ClinicalTrials.gov Identifier:

NCT00492297

EudraCT Number:

2004-000725-30

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years

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

Trial summary

Enrollment Goal

Trial Dates

April 2005 - July 2008

Phase

Phase 2

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Royal Marsden Hospital (London)	London, SW3 6JJ, United Kingdom
Completed	Royal Marsden NHS Trust (Surrey)	Sutton, SM2 5PT, United Kingdom
Completed	Royal Free Hospital	London, NW3 2QG, United Kingdom
Completed	Southampton General Hospital	Southampton, SO16 6YD, United Kingdom
Completed	St Thomas' Hospital	London, SE1 7EH, United Kingdom
Completed	Institut Gustave Roussy - Villejuif	VILLEJUIF, 94805, France
Completed	Institut Claudius Regaud - Toulouse	TOULOUSE, 31052, France
Completed	Addenbrookes Hospital	Cambridge, CB2 0QQ, United Kingdom
Completed	Mount Vernon Hospital	Northwood, HA6 2RN, United Kingdom
Completed	Christie Hospital	Manchester, M20 4BX, United Kingdom
Completed	Centre Léon Bérard	LYON CEDEX, 39373, France
Completed	Hôpital Saint André - Bordeaux	BORDEAUX, 33000, France

Primary Outcome

Overall Best Response
Time Frame:
during or within 30 days after active therapy
Safety Issue:
No

Secondary Outcome

Progression-free Survival
Time Frame:
from start of treatment until progression or death before progression (median 259 days)
Safety Issue:
No
Percentage of Subjects With Progression-free Survival at Specific Time-points
Time Frame:
from start of treatment until progression or death before progression after 3, 6 and 12 months
Safety Issue:
No
Overall Survival
Time Frame:
from start of treatment until death (median 259 days)
Safety Issue:
No
Duration of Response
Time Frame:
from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)
Safety Issue:
No
Duration of Complete Response
Time Frame:
from confirmed CR until PD (median 259 days)
Safety Issue:
No
Duration of Partial Response
Time Frame:
from confirmed PR until PD (median 259 days)
Safety Issue:
No
Disease Control (DC)
Time Frame:
after start of treatment, at 6 months and 12 months
Safety Issue:
No
Duration of Stable Disease
Time Frame:
from start of therapy to PD, only in non-responders (median 259 days)
Safety Issue:
No
Time to Response
Time Frame:
start of therapy to confirmed CR or PR (median 259 days)
Safety Issue:
No
Time to Progression
Time Frame:
From start of treatment until progression (median 259 days)
Safety Issue:
No

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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