Trial · NCT00709826
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
NCT00709826, Phase 2, Completed, Tragara Pharmaceuticals, Inc.; results first posted 2012-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer. Trials, record NCT00709826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00709826
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
- NCT number
- NCT00709826
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Tragara Pharmaceuticals, Inc.
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Interventions
- gemcitabine, placebo, Erlotinib, apricoxib
- First posted
- 2008-07-03
- Last updated
- 2012-11-07
- Results first posted
- 2012-11-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Randomization then every other cycle | Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. |
| Secondary | Overall Survival | Randomization then every other cycle |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Survival | Randomization then every other cycle | Months | MEDIAN | |
| PRIMARY | Progression Free Survival | Randomization then every other cycle | A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Apricoxib/Gemcitabine/Erlotinib | 5.0 | 95% Confidence Interval 3.67 to 50.47 | Months | |
| Overall Survival | Placebo/Gemcitabine/Erlotinib | 4.8 | 95% Confidence Interval 4.07 to 5.70 | Months | |
| Progression Free Survival | Apricoxib/Gemcitabine/Erlotinib | 3.0 | 95% Confidence Interval 2.57 to 6.47 | Months | |
| Progression Free Survival | Placebo/Gemcitabine/Erlotinib | 2.8 | 95% Confidence Interval 2.63 to 4.60 | 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 | Apricoxib/Gemcitabine/Erlotinib | 70 | |
| Overall Study | STARTED | Placebo/Gemcitabine/Erlotinib | 39 | |
| Overall Study | COMPLETED | Apricoxib/Gemcitabine/Erlotinib | 68 | |
| Overall Study | COMPLETED | Placebo/Gemcitabine/Erlotinib | 38 | |
| Overall Study | NOT COMPLETED | Apricoxib/Gemcitabine/Erlotinib | 2 | |
| Overall Study | NOT COMPLETED | Placebo/Gemcitabine/Erlotinib | 1 |
Source ClinicalTrials.gov
Adverse events160
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 | Diarrhea | Gastrointestinal disorders | Apricoxib/Gemcitabine/Erlotinib | 41 | 70 | 41 |
| other | Diarrhea | Gastrointestinal disorders | Placebo/Gemcitabine/Erlotinib | 17 | 39 | 17 |
| other | Nausea | Gastrointestinal disorders | Apricoxib/Gemcitabine/Erlotinib | 41 | 70 | 41 |
| other | Nausea | Gastrointestinal disorders | Placebo/Gemcitabine/Erlotinib | 15 | 39 | 15 |
| other | Fatigue | General disorders | Apricoxib/Gemcitabine/Erlotinib | 40 | 70 | 40 |
| other | Fatigue | General disorders | Placebo/Gemcitabine/Erlotinib | 24 | 39 | 24 |
| other | Anemia | Blood and lymphatic system disorders | Apricoxib/Gemcitabine/Erlotinib | 37 | 70 | 37 |
| other | Anemia | Blood and lymphatic system disorders | Placebo/Gemcitabine/Erlotinib | 18 | 39 | 18 |
| other | Rash | Skin and subcutaneous tissue disorders | Apricoxib/Gemcitabine/Erlotinib | 32 | 70 | 32 |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo/Gemcitabine/Erlotinib | 20 | 39 | 20 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apricoxib/Gemcitabine/Erlotinib | ||
| Total, all-cause mortality | Placebo/Gemcitabine/Erlotinib | ||
| Total, other adverse events | Apricoxib/Gemcitabine/Erlotinib | 70 | 70 |
| Total, other adverse events | Placebo/Gemcitabine/Erlotinib | 39 | 39 |
| Total, serious adverse events | Apricoxib/Gemcitabine/Erlotinib | 16 | 70 |
| Total, serious adverse events | Placebo/Gemcitabine/Erlotinib | 5 | 39 |
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 |
|---|
| Apricoxib/Gemcitabine/Erlotinib vs Placebo/Gemcitabine/Erlotinib: 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/NCT00709826
GET https://conductscience.org/api/trials/v1/NCT00709826/events?page=2