Trial · NCT01173523
Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer
NCT01173523, Phase 2, Completed, David M. Jackman, MD; results first posted 2017-04-11
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer. Trials, record NCT01173523. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01173523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer
- NCT number
- NCT01173523
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- David M. Jackman, MD
- Conditions
- Small Cell Lung Cancer
- Interventions
- STA-9090
- First posted
- 2010-08-02
- Last updated
- 2019-04-16
- Results first posted
- 2017-04-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 8-Week Progression-Free Rate | Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment. | The 8-week progression free rate is defined as the percentage of participants achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
| Secondary | Overall Response Rate | Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort. | The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Progression-Free Survival | Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort. | Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) based on RECIST 1.1 criteria or death. Participants alive without evidence of PD were censored at the date of last adequate disease assessment. Per RECIST 1.1 for target lesions PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression is appearance of one or more new lesions and/or unequivocal progression on existing non-target lesions. |
| Secondary | Overall Survival | Long-term follow-up for survival occurred every 4 weeks. As of this analysis, follow-up among survivors was a median (range) of 11.5 months (0.9-47.9). | Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death due to any cause or date last known alive. |
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 | 8-Week Progression-Free Rate | Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment. | The analysis dataset is comprised of all treated patients. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate | Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort. | The analysis dataset is comprised of all treated patients. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival | Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort. | The analysis dataset is comprised of all treated patients. | months | MEDIAN |
| SECONDARY | Overall Survival | Long-term follow-up for survival occurred every 4 weeks. As of this analysis, follow-up among survivors was a median (range) of 11.5 months (0.9-47.9). | The analysis dataset is comprised of treated patients. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 8-Week Progression-Free Rate | Cohort A: STA-9090 | 0.0 | 95% Confidence Interval 0.0 to 24.7 | percentage of participants | |
| 8-Week Progression-Free Rate | Cohort B: STA-9090 | 8.3 | 95% Confidence Interval 0.2 to 38.5 | percentage of participants | |
| Overall Response Rate | Cohort A: STA-9090 | 0.0 | 95% Confidence Interval 0.0 to 24.7 | percentage of participants | |
| Overall Response Rate | Cohort B: STA-9090 | 0.0 | 95% Confidence Interval 0.0 to 26.5 | percentage of participants | |
| Progression-Free Survival | Cohort A: STA-9090 | 1.61 | 95% Confidence Interval 1.61 to NA | months | |
| Progression-Free Survival | Cohort B: STA-9090 | 1.81 | 95% Confidence Interval 1.15 to NA | months | |
| Overall Survival | Cohort A: STA-9090 | 4.96 | 95% Confidence Interval 3.45 to NA | months | |
| Overall Survival | Cohort B: STA-9090 | 6.70 | 95% Confidence Interval 2.27 to NA | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: STA-9090 | 13 | |
| Overall Study | STARTED | Cohort B: STA-9090 | 12 | |
| Overall Study | COMPLETED | Cohort A: STA-9090 | 0 | |
| Overall Study | COMPLETED | Cohort B: STA-9090 | 0 | |
| Overall Study | NOT COMPLETED | Cohort A: STA-9090 | 13 | |
| Overall Study | NOT COMPLETED | Cohort B: STA-9090 | 12 |
Source ClinicalTrials.gov
Adverse events152
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 distension | Gastrointestinal disorders | Cohort A: STA-9090 | 1 | 13 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort B: STA-9090 | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A: STA-9090 | 2 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B: STA-9090 | 0 | 12 | |
| other | Alanine aminotransferase increased | Investigations | Cohort A: STA-9090 | 3 | 13 | |
| other | Alanine aminotransferase increased | Investigations | Cohort B: STA-9090 | 0 | 12 | |
| other | Alkaline phosphatase increased | Investigations | Cohort A: STA-9090 | 1 | 13 | |
| other | Alkaline phosphatase increased | Investigations | Cohort B: STA-9090 | 1 | 12 | |
| other | Allergic reaction | Immune system disorders | Cohort A: STA-9090 | 1 | 13 | |
| other | Allergic reaction | Immune system disorders | Cohort B: STA-9090 | 1 | 12 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: STA-9090 | 0 | 13 |
| Total, all-cause mortality | Cohort B: STA-9090 | 0 | 12 |
| Total, other adverse events | Cohort A: STA-9090 | 7 | 13 |
| Total, other adverse events | Cohort B: STA-9090 | 8 | 12 |
| Total, serious adverse events | Cohort A: STA-9090 | 4 | 13 |
| Total, serious adverse events | Cohort B: STA-9090 | 3 | 12 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A: STA-9090 vs Cohort B: STA-9090: deaths from any cause | Trial comparisons |
| Cohort A: STA-9090 vs Cohort B: STA-9090: serious adverse events | 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/NCT01173523
GET https://conductscience.org/api/trials/v1/NCT01173523/events?page=2