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Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.


Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.


Inclusion Criteria:



- Subjects who have a life expectancy of at least 12 weeks

- Subjects with histologically or cytologically confirmed unresectable (Stage III) or
metastatic (Stage IV) melanoma

- Subjects must have progressed after receiving at least one cycle of DTIC or TMZ
containing regimen

- Subjects who have an ECOG PS of 0 or 1

- Measurable disease defined as at least one lesion that can be accurately and serially
measured per the modified RECIST criteria

Exclusion Criteria:

- Primary ocular or mucosal melanoma

- 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 [Noninvasive papillary carcinoma], Tis
[Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective
tissue]) or any cancer curatively treated < 5 years prior to study entry

- History of cardiac disease

- Known history of human immunodeficiency virus (HIV) infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.

Outcome Time Frame:

Time from randomization to documented tumor progression or death (median time of 124 days)

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

11718

NCT ID:

NCT00111007

Start Date:

May 2005

Completion Date:

January 2009

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Hinsdale, Illinois  60521
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Louisville, Kentucky  40207
McLean, Virginia  22101
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Denver, Colorado