S10PANI01
Phase II Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cance
Sponsor study identifier
interventional
32
0 countries
N/A
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety profile of panitumumab in patients affected by Head and Neck cancer after at least one cisplatin or carboplatin-based chemotherapy. A translational research study is also planned to evaluate Estimated Glomerular Filtration Rate (EGFR) status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and Human Papilloma Virus (HPV) genotyping by reverse hybridization. Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive disease, unacceptable toxicity, pregnancy, or patient's refusal
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 2015
Actual (reported)December 2015
Actual (reported)December 8, 2015
Actual (reported)December 30, 2015
Actual (reported)Rate of tumor response in advanced platinum-resistant head and neck cancer
To evaluate rate of radiological tumor response in advanced platinum-resistant head and neck cancer
Radiological tumor evaluation every 8 weeks, minimum 12 weeks
Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) v.3
Collection of adverse event for at least the first 8 weeks
Analysis of tumor biomarkers
28 days (1 cycle)
6 mg/kg per administration
IV administration every 2 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Siano M, Molinari F, Martin V, Mach N, Fruh M, Freguia S, Corradino I, Ghielmini M, Frattini M, Espeli V. Multicenter Phase II Study of Panitumumab in Platinum Pretreated, Advanced Head and Neck Squamous Cell Cancer. Oncologist. 2017 Jul;22(7):782-e70. doi: 10.1634/theoncologist.2017-0069. Epub 2017 Jun 7.
Michele Ghielmini, Prof
Oncology Institute of Southern Switzerland
32 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2015
First Posted
December 30, 2015
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Study of Panitumumab-Capecitabine-Oxaliplatin In Wild-Type K-Ras Metastatic Colorectal Cancer Patients
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
October 27, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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