Phase 2
N=101
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Cancer · Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00110994 ↗Enrolled (actual)
101
Serious AEs
35.6%
Results posted
Jun 2011
Primary outcome: Primary: Progression Free Survival (PFS) — 148; 82 days — p=0.068
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sorafenib (Nexavar, BAY43-9006) (Drug); Placebo (Drug); Dacarbazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
148; 82 | 0.068 |
| SECONDARY Overall Survival (OS) |
319; 359 | 0.973 |
| SECONDARY Number of Participants in Tumor Response Categories |
0; 0; 12; 6; 24; 22 | — |
| SECONDARY Time to Progression (TTP) |
148; 82 | 0.039 sig |
| SECONDARY Duration of Response (DOR) |
188; 161 | 0.194 |
| SECONDARY Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted |
1; 1; 1; 2; 34; 34 | — |
| SECONDARY Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted |
-0.004; -0.008 | 0.908 |
| SECONDARY Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment |
-0.015; -0.019 | 0.890 |
| SECONDARY Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted |
0.558; -4.425 | 0.201 |
| SECONDARY Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment |
-2.00; -8.146 | 0.168 |
Summary
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
Eligibility Criteria
Inclusion Criteria
- Patients who have a life expectancy of at least 12 weeks
- Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
- Patients 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 < 3 years prior to study entry
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
Data sourced from ClinicalTrials.gov (NCT00110994). 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.