Abstract | PURPOSE: EXPERIMENTAL DESIGN:
Brivanib was administered orally at a dose of 800 mg once daily. The primary objectives were tumor response rate, time to response, duration of response, progression-free survival, overall survival (OS), disease control rate, time to progression ( TTP), and safety and tolerability. RESULTS: Forty-six patients were treated. Best responses to treatment with brivanib (N = 46 patients) using modified World Health Organization criteria were partial responses for two patients (4.3%), stable disease for 19 patients (41.3%), and progressive disease for 19 patients (41.3%). The tumor response rate was 4.3%; the disease control rate was 45.7%. Median OS was 9.79 months. Median TTP as assessed by study investigators following second-line treatment with brivanib was 2.7 months. The most common adverse events were fatigue, decreased appetite, nausea, diarrhea, and hypertension. CONCLUSION:
Brivanib had a manageable safety profile and is one of the first agents to show promising antitumor activity in advanced HCC patients treated with prior sorafenib.
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Authors | Richard S Finn, Yoon-Koo Kang, Mary Mulcahy, Blase N Polite, Ho Yeong Lim, Ian Walters, Christine Baudelet, Demetrios Manekas, Joong-Won Park |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 18
Issue 7
Pg. 2090-8
(Apr 01 2012)
ISSN: 1557-3265 [Electronic] United States |
PMID | 22238246
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
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Copyright | ©2012 AACR. |
Chemical References |
- AFP protein, human
- Collagen Type IV
- Triazines
- alpha-Fetoproteins
- brivanib
- Alanine
|
Topics |
- Administration, Oral
- Adult
- Aged
- Aged, 80 and over
- Alanine
(adverse effects, analogs & derivatives, therapeutic use)
- Appetite
(drug effects)
- Carcinoma, Hepatocellular
(blood, drug therapy)
- Collagen Type IV
(blood)
- Disease-Free Survival
- Drug Administration Schedule
- Fatigue
(chemically induced)
- Female
- Humans
- Hypertension
(chemically induced)
- Liver Neoplasms
(blood, drug therapy)
- Male
- Middle Aged
- Nausea
(chemically induced)
- Treatment Outcome
- Triazines
(adverse effects, therapeutic use)
- Young Adult
- alpha-Fetoproteins
(analysis)
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