Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer (SHINE)
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| ClinicalTrials.gov Identifier: NCT01457846 |
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Recruitment Status :
Terminated
First Posted : October 24, 2011
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastro-oesophageal Junction Cancer Gastric Cancer | Drug: AZD4547 Drug: paclitaxel | Phase 2 |
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). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 960 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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. |
| Study Start Date : | November 2011 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | February 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Paclitaxel
| Arm | Intervention/treatment |
|---|---|
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Experimental: AZD4547
AZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule
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Drug: AZD4547
Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule. |
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Active Comparator: Paclitaxel
Paclitaxel - 80mg/m² as a 1 hour infusion given weekly on days 1, 8 and 15 of a 28 day cycle (up to the maximum number of cycles per local practice)
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Drug: paclitaxel
Infusion administered once a week, 3 weeks on and 1 week off |
Primary Outcome Measures :
- Median Progression Free Survival [ Time Frame: Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week) ]PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).
Secondary Outcome Measures :
- Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off) [ Time Frame: Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week) ]
- Objective Response Rate [ Time Frame: Week 8 (±1 week) and then every 8 weeks (±1 week) ]ORR=Percentage of patients with at least one visit response of CR (complete response) or PR (partial response) that is confirmed at least 4 weeks later; CR:disappearance of target lesions and no new lesions; PR is at least 30% decrease in sum of diameters of lesions taking as a reference the smallest sum since treatment started.
- Percentage Change From Baseline at Week 8 in Target Lesion Size [ Time Frame: Baseline, Week 8 (±1 week) ]A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.
- Percentage of Patients Without Progressive Disease at 8 Weeks [ Time Frame: Week 8 (±1 week) ]PD = A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diamters
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| Ages Eligible for Study: | 25 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457846
Locations
Show 61 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Paul Stockman, MD PHD | AstraZeneca | |
| Principal Investigator: | Eric Van Cutsem, MD PHD | University Hospital, Gasthuisberg | |
| Principal Investigator: | Yung-Jue Bang, MD, PHD | Seoul National University Hospital |
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01457846 |
| Other Study ID Numbers: |
D2610C00004 |
| First Posted: | October 24, 2011 Key Record Dates |
| Results First Posted: | March 7, 2017 |
| Last Update Posted: | March 7, 2017 |
| Last Verified: | January 2017 |
Keywords provided by AstraZeneca:
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gastro-oesophageal junction cancer gastric cancer lower third oesophageal cancer |
polysomy amplification FGFR |
Additional relevant MeSH terms:
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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |