Know Cancer

or
forgot password

A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.


Phase 2
25 Years
N/A
Open (Enrolling)
Both
Gastro-oesophageal Junction Cancer, Gastric Cancer

Thank you

Trial Information

A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.


A 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 study)


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 has baseline at least 10mm in
the longest diameter for non nodal lesions and is assessed by Computerised
Tomography (CT) or Magnetic Resonance Imaging (MRI)

- Provision of either an archival tumour sample or a fresh tumour sample for
confirmation of FGFR2 polysomy/gene amplification

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
cremophor EL (polyoxyethylated castor oil)

- Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant
therapy given > 6 months; 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 Echocardiogram (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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Investigate the efficacy of AZD4547 vs paclitaxel by assessment of Progression-Free Survival in: all randomised patients; patients with tumours that have FGFR2 amplification & patients with tumours have high FGFR2 amplification alone

Outcome Time Frame:

RECIST assessments will be performed at baseline and every 8 weeks until progression

Safety Issue:

No

Principal Investigator

Paul Stockman, MD PHD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D2610C00004

NCT ID:

NCT01457846

Start Date:

November 2011

Completion Date:

May 2016

Related Keywords:

  • Gastro-oesophageal Junction Cancer
  • Gastric Cancer
  • gastro-oesophageal junction cancer
  • gastric cancer
  • lower third oesophageal cancer
  • polysomy
  • amplification
  • FGFR
  • Adenocarcinoma
  • Esophageal Diseases
  • Stomach Neoplasms

Name

Location