Trial · NCT01404650
Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor
NCT01404650, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2016-10-04
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor. Trials, record NCT01404650. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01404650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor
- NCT number
- NCT01404650
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Gastrointestinal Stromal Tumor
- Interventions
- AUY922
- First posted
- 2011-07-28
- Last updated
- 2016-10-04
- Results first posted
- 2016-10-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | At 6 and 12 weeks then every 9 weeks thereafter until progression or intolerable toxicity, up to 4 years. | Measured from time of randomization until objective tumor progression or death; assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. |
| Secondary | Response Rate (RR) | At 6 and 12 weeks then every 9 weeks thereafter until progressive disease or intolerable toxicity, for up to 4 years. | Defined as the proportion of complete and partial responses, assessed per RECIST v1.1. Complete response (CR) defined as a disappearance of all lesions; partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment. |
| Secondary | Overall Survival (OS) | Every 3 months until patient death or lost to follow-up, for up to 4 years. | Evidence of survival was obtained by clinic visit or telephone contact from the time of first dose until death from any cause. |
| Secondary | Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Days 1, 8 and 15 of each 21-day cycle plus 30 days after treatment discontinuation. | Worst toxicity grades per patient were tabulated for select adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.0 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | At 6 and 12 weeks then every 9 weeks thereafter until progression or intolerable toxicity, up to 4 years. | months | MEDIAN | |
| SECONDARY | Response Rate (RR) | At 6 and 12 weeks then every 9 weeks thereafter until progressive disease or intolerable toxicity, for up to 4 years. | Of 25 patients enrolled, 4 patients were not evaluable for response due to treatment discontinuation prior to first disease evaluation. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Every 3 months until patient death or lost to follow-up, for up to 4 years. | All 25 patients who received treatment were included in the analysis of overall survival. | months | MEDIAN |
| SECONDARY | Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Days 1, 8 and 15 of each 21-day cycle plus 30 days after treatment discontinuation. | All participants who received at least one dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | AUY922 | 3.9 | 95% Confidence Interval 2.5 to 5.3 | months | |
| Response Rate (RR) | AUY922 | Stable Disease | 60 | percentage of participants | |
| Response Rate (RR) | AUY922 | Objective Response | 4 | percentage of participants | |
| Response Rate (RR) | AUY922 | Progressive Disease | 20 | percentage of participants | |
| Overall Survival (OS) | AUY922 | 8.5 | 95% Confidence Interval 5.2 to 16.7 | months | |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | AUY922 | Anemia | 10 | participants | |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | AUY922 | Leukopenia | 1 | participants | |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | AUY922 | Thrombocytopenia | 1 | participants | |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | AUY922 | Diarrhea | 16 | participants | |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | AUY922 | Fatigue | 13 | participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AUY922 | 25 | |
| Overall Study | COMPLETED | AUY922 | 25 | |
| Overall Study | NOT COMPLETED | AUY922 | 0 |
Source ClinicalTrials.gov
Adverse events33
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 | Abdominal pain | Gastrointestinal disorders | AUY922 | 3 | 25 | |
| other | Constipation | Gastrointestinal disorders | AUY922 | 3 | 25 | |
| other | Nausea | Gastrointestinal disorders | AUY922 | 11 | 25 | |
| other | Diarrhea | Gastrointestinal disorders | AUY922 | 16 | 25 | |
| other | Vomiting | Gastrointestinal disorders | AUY922 | 7 | 25 | |
| other | Fatigue | General disorders | AUY922 | 13 | 25 | |
| other | Alkaline phosphatase increased | Investigations | AUY922 | 2 | 25 | |
| other | Asthenia | Musculoskeletal and connective tissue disorders | AUY922 | 5 | 25 | |
| other | Blurred vision | Eye disorders | AUY922 | 9 | 25 | |
| other | Flashing lights | Eye disorders | AUY922 | 7 | 25 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AUY922 | ||
| Total, other adverse events | AUY922 | 25 | 25 |
| Total, serious adverse events | AUY922 | 8 | 25 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01404650
GET https://conductscience.org/api/trials/v1/NCT01404650/results?page=2