This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Preliminary Phase 1 Data For Cabozantinib In Japanese Patients Presented At ESMO 2012

Exelixis, Inc. (NASDAQ:EXEL) today reported preliminary data from an ongoing phase 1 dose escalation study of cabozantinib in Japan. Hiroshi Nokihara, M.D., Ph.D., a physician at the National Cancer Center Hospital in Tokyo, Japan, and an investigator on the trial, presented the data today in a poster discussion session at the European Society for Medical Oncology 2012 Annual Meeting (Abstract #1708PD) in Vienna, Austria.

The primary objective of the phase 1, open label, multiple cohort dose escalation study is to determine the recommended phase 2 dose of cabozantinib administered once-daily over a 4-week cycle in Japanese patients with advanced or metastatic solid tumors. Doses evaluated were 40 mg, 60 mg, or 80 mg of cabozantinib in the capsule configuration. Secondary objectives are to assess the safety and tolerability of multiple doses of cabozantinib, plasma pharmacokinetics, and tumor response.

As of the June 30, 2012 cut-off, 14 patients with a variety of solid tumors had been enrolled in the study: non-small cell lung cancer (NSCLC) (5), gastrointestinal stromal tumor (4), colorectal cancer (2), medullary thyroid cancer (1), thymic cancer (1), and leiomyosarcoma (1). The median number of prior treatments was 3 (range: 2-6) for all 14 patients, and 4 (range: 2-6) for the NSCLC subgroup. Dose-limiting toxicity of Grade 3 hypertension was reported in 2 patients, and the recommended phase 2 dose is 60 mg daily. Pharmacokinetic analyses show that cabozantinib exhibited dose-linear increases in exposure over the range of doses evaluated, and a 5- to 6-fold accumulation was observed on Day 19 following repeated daily dosing. These analyses also show that cabozantinib exposure in Japanese patients is approximately 2-fold higher than that observed in non-Japanese patients.

Of the 14 patients, 4 had confirmed partial responses (cPR) as their best tumor response, 8 had stable disease of at least 12 weeks, and 2 had progressive disease. Eleven of the 14 patients had decreases in tumor size compared with baseline. The 4 cPRs were observed in the NSCLC subgroup of 5 patients. All 5 NSCLC patients had tumor regression ranging from 33% to 41%. All 4 patients with a cPR had mutations or translocations involving either EGFR, RET, or ALK, while the NSCLC patient with a best response of stable disease had no mutations in these genes or in KRAS. Treatment duration for the NSCLC subgroup ranged from 4 to 15+ months. Five patients remained on study as of the June 30, 2012 cut-off.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

DOW 17,683.78 -46.33 -0.26%
S&P 500 2,072.85 -3.93 -0.19%
NASDAQ 4,998.5170 -10.6970 -0.21%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs