Trial reportPloS one2010
A phase II trial of sorafenib in metastatic melanoma with tissue correlates.
Trial report in PloS one, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00119249 (A Phase II Study of BAY 43-9006), which is not on this map. Cited by 44 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and IV Melanoma (IND 69,869)
Who cites it
44 citing papers in PubMed, 5 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- Next-generation sequencing for guiding matched targeted therapies in people with relapsed or metastatic cancer.The Cochrane database of systematic reviews · 2025Pooled it
- Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review.PLoS biology · 2017Pooled it
- Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy.Cancer research · 2016Pooled it
- Incidence and risk of sorafenib-induced hypertension: a systematic review and meta-analysis.Journal of clinical hypertension (Greenwich, Conn.) · 2014Pooled it
- Risk of hypertension in cancer patients treated with sorafenib: an updated systematic review and meta-analysis.Journal of human hypertension · 2013Pooled it
- Correlation of somatic mutations and clinical outcome in melanoma patients treated with Carboplatin, Paclitaxel, and sorafenib.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014Trial
- A phase II study of gemcitabine and cisplatin plus sorafenib in patients with advanced biliary adenocarcinomas.British journal of cancer · 2013Trial
- Phase III trial of carboplatin and paclitaxel with or without sorafenib in metastatic melanoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013Trial
- Expression of drug targets in patients treated with sorafenib, carboplatin and paclitaxel.PloS one · 2013Trial
- Sorafenib in advanced melanoma: a critical role for pharmacokinetics?British journal of cancer · 2012Trial
- Melanoma: Pathogenesis and Targeted Therapy.MedComm · 2026Review
- A Review of FDA-Approved Multi-Target Angiogenesis Drugs for Brain Tumor Therapy.International journal of molecular sciences · 2025Review
- Optimal treatment strategy for metastatic melanoma patients harboringTherapeutic advances in medical oncology · 2020Review
- Developments in the Space of New MAPK Pathway Inhibitors for BRAF-Mutant Melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019Review
- Review
- Two synchronous malignancies: nodular melanoma and renal cell carcinoma in a patient with an underlying germlineBMJ case reports · 2019Article
- DNA methylation alterations as therapeutic prospects in thyroid cancer.Journal of endocrinological investigation · 2019Review
- Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAFInvestigational new drugs · 2018Article
- Bowel Perforation After Treatment with Sorafenib: A Case Report and Review of Literature.Journal of gastrointestinal cancer · 2016Article
- The cutting edge of metastatic melanoma therapy.Melanoma management · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundSorafenib monotherapy in patients with metastatic melanoma was explored in this multi-institutional phase II study. In correlative studies the impact of sorafenib on cyclin D1 and Ki67 was assessed. METHODOLOGY/PRINCIPAL
findingsThirty-six patients treatment-naïve advanced melanoma patients received sorafenib 400 mg p.o. twice daily continuously. Tumor BRAF(V600E) mutational status was determined by routine DNA sequencing and mutation-specific PCR (MSPCR). Immunohistochemistry (IHC) staining for cyclin D1 and Ki67 was performed on available pre- and post treatment tumor samples. The main toxicities included diarrhea, alopecia, rash, mucositis, nausea, hand-foot syndrome, and intestinal perforation. One patient had a RECIST partial response (PR) lasting 175 days. Three patients experienced stable disease (SD) with a mean duration of 37 weeks. Routine BRAF(V600E) sequencing yielded 27 wild-type (wt) and 6 mutant tumors, whereas MSPCR identified 12 wt and 18 mutant tumors. No correlation was seen between BRAF(V600E) mutational status and clinical activity. No significant changes in expression of cyclin D1 or Ki67 with sorafenib treatment were demonstrable in the 15 patients with pre-and post-treatment tumor samples. CONCLUSIONS/SIGNIFICANCE: Sorafenib monotherapy has limited activity in advanced melanoma patients. BRAF(V600E) mutational status of the tumor was not associated with clinical activity and no significant effect of sorafenib on cyclin D1 or Ki67 was seen, suggesting that sorafenib is not an effective BRAF inhibitor or that additional signaling pathways are equally important in the patients who benefit from sorafenib.
trial registrationClinical Trials.gov NCT00119249.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.