Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Pfizer Discontinues Phase 3 Trial For Advanced Breast Cancer Med

By Pharmaceutical Processing | April 2, 2009

Pfizer Inc. today announced the discontinuation of one of its Phase 3 studies based on statistical assessment for futility: the SUN 1107 Phase 3 study of Sutent(R) (sunitinib malate) in advanced breast cancer. SUN 1107 evaluated single-agent sunitinib versus single-agent capecitabine for the treatment of a broad range of patients with advanced breast cancer after failure of standard treatment. An independent Data Monitoring Committee (DMC) found that even if the trial had been allowed to continue, treatment with single-agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to single-agent capecitabine in the study population. Data from this trial are currently being analyzed. “We are disappointed with these results given the previous findings that suggested sunitinib may provide benefit for patients with this difficult-to-treat cancer,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “In ongoing studies, we remain committed to evaluating sunitinib in advanced breast cancer and are continuing to study sunitinib in different populations and with different regimens.” Pfizer has notified clinical trial investigators involved in the study and regulatory agencies of these findings. The Company encourages investigators to determine the best course of action for their individual patients. The company is continuing to evaluate sunitinib as a single-agent and in combination with standard-of-care chemotherapy in specific patient populations with advanced breast cancer through three additional Phase 3 and two Phase 2 trials. Sunitinib is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced / metastatic renal cell carcinoma (RCC) based on efficacy and safety data from large, randomized Phase 3 clinical trials. Sunitinib has played an important role in reshaping the treatment landscape for these two difficult-to-treat cancers. To date, more than 58,000 patients globally have been treated with sunitinib in the clinical setting and in clinical trials.

Related Articles Read More >

Driving success in fast-paced high-tech pharma construction projects
This is a photo of the Fujifilm Diosynth Biotechnologies plant under construction in Holly Springs, North Carolina.
Fujifilm, Regeneron ink $3B U.S. manufacturing agreement
This is the logo of Johnson & Johnson.
J&J breaks ground on $2B manufacturing facility in North Carolina
sherwin-williams-pharma-facility (1)
Sherwin-Williams expands flooring solutions for pharma facilities
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE