AstraZeneca PLC AZ head and neck cancer trials resume enrolment (7947P)
November 22 2016 - 1:02AM
UK Regulatory
TIDMAZN
RNS Number : 7947P
AstraZeneca PLC
22 November 2016
22 November 2016, 07:00
ASTRAZENECA HEAD AND NECK CANCER TRIALS
RESUME NEW PATIENT ENROLMENT AS FDA LIFTS
PARTIAL CLINICAL HOLD
AstraZeneca today announced that the US FDA has lifted the
partial clinical hold on the enrolment of new patients with head
and neck squamous cell carcinoma (HNSCC) for clinical trials of
durvalumab as monotherapy and in combination with tremelimumab or
other potential medicines.
The Phase III KESTREL trial has already re-opened for new
patient enrolment at some clinical study sites and the EAGLE trial
is expected to resume recruitment shortly, without amendments to
either protocol. AstraZeneca will progressively resume enrolment
for all HNSCC trials across the participating sites in the US and
globally, subject to national health authority and ethics committee
approval where required. The status of active recruitment will be
reflected on clinicaltrials.gov in the coming days.
The partial clinical hold on new patient enrolment was
communicated on 27 October, after preliminary findings from ongoing
clinical trials related specifically to head and neck cancer. The
FDA lifted the partial clinical hold following a review of the
comprehensive analysis provided by AstraZeneca of bleeding events
that were observed as part of the routine safety monitoring of the
Phase III KESTREL and EAGLE trials.
Monitoring of safety signals is an integral part of the
development process for new medicines. Bleeding is a known
complication in treatments of head and neck cancers primarily due
to the nature of the underlying disease, the proximity of tumours
to major blood vessels and use of prior cancer therapies, which may
involve surgery and radiation.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca.com and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
This information is provided by RNS
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