Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)

• Conditions: locally advanced or metastatic gastric adenocarcinoma that has FGFR2 polysomy or FGFR2 gene amplification who have relapsed or have not responded, following one prior chemotherapeutic regimen.; MedDRA version: 14.1Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023377-19-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Female or male aged 25 or over
Histological diagnosis of locally advanced or metastatic gastro
adenocarcinoma (including adenocarcinoma of the lower third of the
oesophagus or the gastro oesophageal junction )
Radiographically confirmed progression after 1 prior chemotherapy or
chemoradiotherapy for gastric cancer. Suitable for and expected to
benefit from paclitaxel monotherapy.
At least one lesion, not previously irradiated, that at baseline is equal to
or larger than 10mm in the longest diameter for non nodal lesions with
CT or MRI
Provision of either an archival tumour sample or a fresh tumour sample
for confirmation of FGFR2 polysomy/gene amplification by the sponsor
approved laboratory. Patients with FGFR2 polysomy or gene amplified
tumours will be eligible for the main study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Prior exposure to AZD4547 or history of hypersensitivity other drugs
similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or
formulated in Cremaphor EL (polyoxyethylated castor oil)
Major surgery, radiotherapy with wide field of radiation or any cancer
treatment within 4 weeks before the first dose of the study treatment
With the exception of alopecia, any unresolved toxicities from prior
therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at
the time of starting study treatment.
Blood and ECG readings that are deemed to be abnormal by falling
outside of the reference ranges in the protocol inclusion/exclusion
section.
Taking other regular medication that are predicted to interact with
AZD4547 due to their route of metabolism.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified