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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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.


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Best Response

Outcome Description:

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.

Outcome Time Frame:

during or within 30 days after active therapy

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

11538

NCT ID:

NCT00492297

Start Date:

April 2005

Completion Date:

June 2008

Related Keywords:

  • Melanoma
  • Melanoma

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