Trial · NCT01457846
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
NCT01457846, Phase 2, Terminated, AstraZeneca; results first posted 2017-03-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer. Trials, record NCT01457846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01457846
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
- NCT number
- NCT01457846
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 960 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Gastro-oesophageal Junction Cancer, Gastric Cancer
- Interventions
- AZD4547, paclitaxel
- First posted
- 2011-10-24
- Last updated
- 2017-03-07
- Results first posted
- 2017-03-07
- Limitations and caveats
Prompted by slow recruitment, AZ and the SRC instigated unscheduled analysis of the efficacy and tolerability. It was concluded that the study was unlikely to meet its primary objective. Enrolment ceased and the study closed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression Free Survival | 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 | Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off) | Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week) | |
| Secondary | Objective Response Rate | 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. |
| Secondary | Percentage Change From Baseline at Week 8 in Target Lesion Size | 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. |
| Secondary | Percentage of Patients Without Progressive Disease at 8 Weeks | 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 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression Free Survival | Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week) | Full analysis set | months | NUMBER |
| SECONDARY | Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off) | Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week) | This secondary analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients). | Patients | NUMBER |
| SECONDARY | Objective Response Rate | Week 8 (±1 week) and then every 8 weeks (±1 week) | The analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients). | Patients (%) | NUMBER |
| SECONDARY | Percentage Change From Baseline at Week 8 in Target Lesion Size | Baseline, Week 8 (±1 week) | Full analysis set - all treated patients with at least one post baseline RECIST target lesion assessment scan | Percentage change | MEAN |
| SECONDARY | Percentage of Patients Without Progressive Disease at 8 Weeks | Week 8 (±1 week) | Full analysis set - all treated patients | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression Free Survival | AZD4547 | 1.8 | months | ||
| Median Progression Free Survival | Paclitaxel | 3.5 | months | ||
| Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off) | AZD4547 | 27 | Patients | ||
| Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off) | Paclitaxel | 18 | Patients | ||
| Objective Response Rate | AZD4547 | 2.6 | Patients (%) | ||
| Objective Response Rate | Paclitaxel | 23.3 | Patients (%) | ||
| Percentage Change From Baseline at Week 8 in Target Lesion Size | AZD4547 | 28.4 | Standard Deviation 44.4 | Percentage change | |
| Percentage Change From Baseline at Week 8 in Target Lesion Size | Paclitaxel | -1.1 | Standard Deviation 36.18 | Percentage change | |
| Percentage of Patients Without Progressive Disease at 8 Weeks | AZD4547 | 24.4 | Percentage of patients | ||
| Percentage of Patients Without Progressive Disease at 8 Weeks | Paclitaxel | 53.3 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD4547 | 41 | |
| Overall Study | STARTED | Paclitaxel | 30 | |
| Overall Study | Received Treatment | AZD4547 | 40 | |
| Overall Study | Received Treatment | Paclitaxel | 27 | |
| Overall Study | Did Not Receive Treatment | AZD4547 | 1 | |
| Overall Study | Did Not Receive Treatment | Paclitaxel | 3 | |
| Overall Study | Ongoing Treatment at Data Cut-off | AZD4547 | 1 | |
| Overall Study | Ongoing Treatment at Data Cut-off | Paclitaxel | 1 | |
| Overall Study | COMPLETED | AZD4547 | 0 | |
| Overall Study | COMPLETED | Paclitaxel | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events136
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | AZD4547 | 7 | 40 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Paclitaxel | 6 | 27 | 6 |
| other | Detatchment of retinal pigment epithelium | Eye disorders | AZD4547 | 6 | 40 | 6 |
| other | Detatchment of retinal pigment epithelium | Eye disorders | Paclitaxel | 0 | 27 | 0 |
| other | Nausea | Gastrointestinal disorders | AZD4547 | 10 | 40 | 10 |
| other | Nausea | Gastrointestinal disorders | Paclitaxel | 6 | 27 | 6 |
| other | Fatigue | General disorders | AZD4547 | 6 | 40 | 6 |
| other | Fatigue | General disorders | Paclitaxel | 8 | 27 | 8 |
| other | Diarrhoea | Hepatobiliary disorders | AZD4547 | 6 | 40 | 6 |
| other | Diarrhoea | Hepatobiliary disorders | Paclitaxel | 6 | 27 | 6 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD4547 | ||
| Total, all-cause mortality | Paclitaxel | ||
| Total, other adverse events | AZD4547 | 39 | 40 |
| Total, other adverse events | Paclitaxel | 26 | 27 |
| Total, serious adverse events | AZD4547 | 8 | 40 |
| Total, serious adverse events | Paclitaxel | 6 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AZD4547 vs Paclitaxel: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01457846
GET https://conductscience.org/api/trials/v1/NCT01457846/events?page=2