Phase 3 N=270 Randomized Triple-blind Treatment

A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

Melanoma

Bottom Line

View on ClinicalTrials.gov: NCT00111007 ↗

Enrolled (actual)

270

Serious AEs

48.9%

Results posted

Feb 2011

Primary outcome: Primary: Progression Free Survival (PFS) — 122; 125 days — p=0.492

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sorafenib (Nexavar, BAY43-9006) (Drug); Carboplatin/Paclitaxel (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Sep 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival (PFS)	122; 125	0.492
SECONDARY Overall Survival (OS)	294; 294	0.979
SECONDARY Time to Progression (TTP)	126; 126	0.331
SECONDARY Duration of Response (DOR)	228; 166	0.146
SECONDARY Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted	10; 4; 9; 10; 70; 82	0.389

Summary

The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00111007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.