NEWS HIGHLIGHTSMedia Articles Related to Vectibix (Panitumumab)
Amgen Announces Overall Survival Results For Vectibix(R) In First-Line Metastatic Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.06]
Amgen (Nasdaq: AMGN) announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival.
Poniard Pharmaceuticals Announces Updated Positive Clinical Data From Phase 2 Trial Of Picoplatin In Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.18]
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC).
'Cross-talk' Mechanism Contributes To Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.14]
Researchers at the University of Wisconsin-Madison School of Medicine and Public Health have identified a molecular mechanism that allows two powerful signaling pathways to interact and begin a process leading to colorectal tumors. "We are very excited about these findings," says Vladimir Spiegelman, an associate professor of dermatology. "Drugs could be developed to block this mechanism and prevent colorectal cancer, which affects millions of people worldwide.
African-Americans With Colorectal Cancer Have Poorer Outcomes, Lower Survival Rates
Source: Colorectal Cancer News From Medical News Today [2009.11.13]
New research published in the November issue of the Journal of the American College of Surgeons shows that African-American patients with colorectal cancer are more likely to be diagnosed with advanced disease and are less likely to undergo surgical procedures compared with Caucasians, suggesting that improvements in screening and rates of operation may reduce differences in colorectal cancer outcomes for African-Americans.
Gastrocor(R) Introduces New FISH Test For Colorectal Cancer Detection
Source: Colorectal Cancer News From Medical News Today [2009.11.02]
GastroFISH™ is the first tissue-based fluorescence in situ hybridization (FISH) test for the detection of chromosomal anomalies associated with colon cancer. "We are excited to be the first laboratory to offer GastroFISH for the colon. Using current histological techniques, identifying adenomas with a high risk for progression to cancer is not possible.
Published Studies Related to Vectibix (Panitumumab)
Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. [2009.04.01]
BACKGROUND: The authors explored the association of skin toxicity (ST) severity as measured by patient-reported ST and Common Terminology Criteria for Adverse Events (CTCAE) grading with efficacy of panitumumab, a fully human antiepidermal growth factor receptor antibody, from a phase 3 metastatic colorectal cancer (CRC) trial... CONCLUSIONS: More severe ST, by both clinical grading and PRO, is associated with better CRC symptoms and HRQOL and with longer OS and PFS among panitumumab-treated patients. The associations for PFS were more pronounced in patients with WT KRAS tumors. (c) 2009 American Cancer Society
FDA review of a panitumumab (Vectibix) clinical trial for first-line treatment of metastatic colorectal cancer. [2009.03]
On September 27, 2006, the U.S. Food and Drug Administration granted accelerated approval to panitumumab (Vectibix; Amgen, Inc., Thousand Oaks, CA) for the treatment of patients with epidermal growth factor receptor-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens...
A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. [2009.02.10]
PURPOSE: Panitumumab, a fully human antibody targeting the epidermal growth factor receptor, is active in patients with metastatic colorectal cancer (mCRC). This trial evaluated panitumumab added to bevacizumab and chemotherapy (oxaliplatin- and irinotecan-based) as first-line treatment for mCRC... CONCLUSION: The addition of panitumumab to bevacizumab and oxaliplatin- or irinotecan-based chemotherapy results in increased toxicity and decreased PFS. These combinations are not recommended for the treatment of mCRC in clinical practice.
Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. [2008.04.01]
PURPOSE: Panitumumab, a fully human antibody against the epidermal growth factor receptor (EGFR), has activity in a subset of patients with metastatic colorectal cancer (mCRC). Although activating mutations in KRAS, a small G-protein downstream of EGFR, correlate with poor response to anti-EGFR antibodies in mCRC, their role as a selection marker has not been established in randomized trials... CONCLUSION: Panitumumab monotherapy efficacy in mCRC is confined to patients with WT KRAS tumors. KRAS status should be considered in selecting patients with mCRC as candidates for panitumumab monotherapy.
U.s. Food and drug administration approval: panitumumab for epidermal growth factor receptor-expressing metastatic colorectal carcinoma with progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. [2008.03.01]
CONCLUSIONS: Panitumumab received accelerated approval based on improvement in PFS and an independently confirmed response rate of 8%, similar to that observed with other active agents at this advanced stage of disease. Confirmation of clinical benefit will be required for full approval.
Clinical Trials Related to Vectibix (Panitumumab)
Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRC [Recruiting]
This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2
part, phase 2 study designed to evaluate the safety and efficacy of AMG 102 or AMG 479 in
combination with panitumumab versus panitumumab alone in subjects with metastatic colorectal
cancer whose tumors are wild-type KRAS status.
Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer [Not yet recruiting]
In this Phase II trial, the investigators will evaluate the combination of gemcitabine,
carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative
breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be
examined for the presence of various markers, including K-ras and PI3K-activating mutations,
EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a
patient subset that is particularly responsive to treatment with a panitumumab-containing
combination.
Safety and Efficacy Study of FOLFOX4+Panitumumab vs.FOLFIRI+Panitumumab in Subjects WT KRAS Colorectal Cancer and Liver-only Metastases [Recruiting]
The purpose of the study is to evaluate the efficacy and safety of the combination of
Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects
with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.
Ph2 Biomarker (Mechanism of K-ras Dependency) in Wt KRAS Metastatic Colorectal Cancer Patients [Recruiting]
This is a global, multicenter, open-label phase 2 study designed to evaluate the
mechanism(s) of resistance to the anti-EGFR antibody panitumumab given in combination with
irinotecan in mCRC subjects with wild-type KRAS tumor status at the time of initial
diagnosis.
In Part 1, all subjects will undergo a baseline tumor biopsy and will receive panitumumab
with irinotecan. Subjects that respond (complete or partial response ± confirmation) or
have stable disease (based on modified RECIST criteria) will continue to receive treatment
until radiographically-confirmed disease progression. These subjects will then undergo a
second tumor biopsy and blood sampling and then proceed to Part 2 of the study.
Subjects that experience radiographically-confirmed disease progression at the time of first
tumor measurement will undergo blood sampling then proceed directly on to Part 2 of the
study; tumor biopsy will not be required in these subjects.
In Part 2, all subjects will receive panitumumab with AMG 479. In both parts of the study,
panitumumab and irinotecan (Part 1) and panitumumab and AMG 479 (Part 2) will be
administered Q2W until disease progression, intolerability, withdrawal of consent, death, or
unless otherwise indicated by the study team.
All subjects that permanently discontinue all investigational products will complete a
safety follow-up visit 30 days (+3 day window) after the last dose of investigational
product.
Subjects that end the treatment prior to radiographically-confirmed disease progression will
be followed for radiographically-confirmed disease progression at the 30 day safety
follow-up visit and then every 8 weeks (± 1 week window) until radiographically-confirmed
disease progression, start of new cancer treatment, death, withdrawal of consent or at the
end of the study, whichever is earlier.
Subjects who have discontinued study treatment for any reason but have not withdrawn full
consent to participate in the study, will be contacted by telephone or clinical visit every
3 months for overall survival and disease status assessments up to 2 years after the last
subject is enrolled in Part 1.
New Individualized Therapy Trial for Metastatic Colorectal Cancer [Recruiting]
The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in
combination with panitumumab for the treatment of stage IV colorectal cancer that has spread
to the liver. It will also assess the whether imatinib mesylate, either alone or in
combination with panitumumab, is effective in treating this type of cancer. In addition,
the study will evaluate the feasibility of a predefined lab score and whether it can predict
which patients will respond to treatment with imatinib mesylate.
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