Trial · NCT01227018
PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
NCT01227018, Phase 2, Terminated, Vanderbilt-Ingram Cancer Center; results first posted 2014-07-23
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer. Trials, record NCT01227018. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
- NCT number
- NCT01227018
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
- Interventions
- STA-9090, Radiologic imaging, blood draw
- First posted
- 2010-10-22
- Last updated
- 2014-07-23
- Results first posted
- 2014-07-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Rate | at 8 weeks from the start of therapy | Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy. |
| Secondary | Best Response | On-treatment date, to date of disease progression (assessed up to 1 year) | Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD. |
| Secondary | Overall Survival | study entry to date of death or last date known alive (assessed over 2.5 yrs) | Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details) |
| Secondary | Number of Patients With Each Worst Grade Toxicity | On study date to 30 days following final dose of study drug | Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death |
| Other | Biomarker Evaluation | Pre-treatment and 1 week post-treatment | Serum will be tested for biomarkers that may be predictive of response, optional per patient consent. |
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 | Disease Control Rate | at 8 weeks from the start of therapy | Patients who received treatment and who were available for determination of response. | percentage of participants | NUMBER |
| SECONDARY | Best Response | On-treatment date, to date of disease progression (assessed up to 1 year) | All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response. | participants | NUMBER |
| SECONDARY | Overall Survival | study entry to date of death or last date known alive (assessed over 2.5 yrs) | All patients are included in the analysis on intention-totreat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date. | days | MEDIAN |
| SECONDARY | Number of Patients With Each Worst Grade Toxicity | On study date to 30 days following final dose of study drug | Total number of patients reported with any toxicity related to study treatment. One patient withdrew before treatment. One patient did not have a toxicity related to study drug or therapy. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Biomarker Evaluation | Pre-treatment and 1 week post-treatment | The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed. |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Rate | STA-9090 | 21 | percentage of participants | ||
| Best Response | STA-9090 | Complete response | 0 | participants | |
| Best Response | STA-9090 | Partial response | 0 | participants | |
| Best Response | STA-9090 | Stable disease | 3 | participants | |
| Best Response | STA-9090 | Progressive disease | 8 | participants | |
| Best Response | STA-9090 | Not Assessed | 3 | participants | |
| Best Response | STA-9090 | Not Evaluable | 1 | participants | |
| Overall Survival | STA-9090 | 125 | 95% Confidence Interval 45 to 148 | days | |
| Number of Patients With Each Worst Grade Toxicity | STA-9090 | Patients with worst grade toxicity 1 | 0 | participants | |
| Number of Patients With Each Worst Grade Toxicity | STA-9090 | Patients with worst grade toxicity 2 | 5 | participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | STA-9090 | 15 | |
| Overall Study | COMPLETED | STA-9090 | 0 | |
| Overall Study | NOT COMPLETED | STA-9090 | 15 |
Source ClinicalTrials.gov
Adverse events97
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 | STA-9090 | 9 | 14 | 16 |
| other | diarrhea | Gastrointestinal disorders | STA-9090 | 8 | 14 | 25 |
| other | constipation | Gastrointestinal disorders | STA-9090 | 7 | 14 | 10 |
| other | nausea | Gastrointestinal disorders | STA-9090 | 6 | 14 | 16 |
| other | vomiting | Gastrointestinal disorders | STA-9090 | 3 | 14 | 10 |
| other | flatulence | Gastrointestinal disorders | STA-9090 | 2 | 14 | 2 |
| other | gastrointestinal disorders-other | Gastrointestinal disorders | STA-9090 | 2 | 14 | 2 |
| other | ascites | Gastrointestinal disorders | STA-9090 | 1 | 14 | 1 |
| other | bloating | Gastrointestinal disorders | STA-9090 | 1 | 14 | 1 |
| other | dyspepsia | Gastrointestinal disorders | STA-9090 | 1 | 14 | 2 |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | STA-9090 | ||
| Total, other adverse events | STA-9090 | 13 | 14 |
| Total, serious adverse events | STA-9090 | 9 | 14 |
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.
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/NCT01227018
GET https://conductscience.org/api/trials/v1/NCT01227018/events?page=2