Trial · NCT01652976
Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma
NCT01652976, Phase 2, Completed, University of Florida; results first posted 2019-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma. Trials, record NCT01652976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01652976
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma
- NCT number
- NCT01652976
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Pancreatic Cancer Metastatic
- Interventions
- Dasatinib, mFOLFOX6
- First posted
- 2012-07-30
- Last updated
- 2021-01-05
- Results first posted
- 2019-06-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 3 years | Determine activity of 5-Fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus dasatinib on progression free survival (PFS) in patients with metastatic pancreatic adenocarcinoma |
| Secondary | Response Rate | 3 years | To determine the response rate (RR) by RECIST 1.1 criteria. The response rate is the number of subjects who had either a complete or partial response by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). The imaging modality used for all RECIST assessments in this study was CT. |
| Secondary | Freedom From Metastasis | 3 years | To determine the rate of freedom from metastasis (FFM), which is defined as the percentage of subjects with documented progressive disease (by RECIST 1.1 criteria) who had no new lesions. RECIST 1.1 criteria defines progressive disease as the appearance of one or more new lesions and/or the increase of the sum of the largest diameter of the target lesions by at least 20% from the smallest sum collected (the sum must also have increased by at least 5 mm). |
| Secondary | Median Time To Progression | 3 years | To determine the median time to progression (TTP). TTP is defined as the time (in months) from when a subject achieves either a complete or partial response by RECIST 1.1 criteria until progressive disease (by RECIST 1.1 criteria) or death occurs. |
| Secondary | Median Overall Survival | 4 years | To determine median overall survival (OS) in months |
| Secondary | Clinical Benefit Rate | 3 years | To determine the clinical benefit rate (CBR). The CBR is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease. |
| Secondary | Site of Failure | 3 years | To determine the site of failure of this regimen in this population. The site of failure is the anatomical site(s) where disease progression by RECIST 1.1 criteria was noted on imaging. |
| Secondary | Safety and Tolerability | 3 years | To determine the safety profile and tolerability of this regimen in this population by evaluating acute treatment related toxicities using CTCAE v4.0 criteria. Using the CTCAE v4.0, the severity of each adverse event reported was graded on a scale of 1 (mild severity) to 5 (fatal). For this outcome measure the percentage of subjects experiencing any adverse event of each CTCAE grade was tabulated. |
| Secondary | Drug Compliance | 3 years | To determine patient compliance with oral therapy. For this outcome measure, compliance with oral therapy is defined as the percentage of subjects that took dasatinib for at least one cycle. Compliance with oral therapy was documented with a medication diary that subjects were asked to complete to document whether each dose of dasatinib was taken. |
| Secondary | Quality of Life, as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ), 2007 | 3 years | To determine the quality of life (QOL) of patients receiving this therapy using the CTSQ questionnaire. The CTSQ consists of 16 questions where subjects respond with a score on a scale of 0 (worst)-4 (best). The responses to the questions are used to calculate 3 subscores: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Each subscore is calculated by multiplying the mean response value for the questions used to calculate that subscore by 25. The maximum value is 100 and the minimum value is 0 for all 3 subscores. A higher subscore indicates better QOL in that area. The mean difference in each of the 3 subscores from baseline and 95% confidence interval for the entire study population is reported here. A negative mean difference indicates a decrease from baseline in QOL for that area. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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) | 3 years | months | MEDIAN | |
| SECONDARY | Response Rate | 3 years | percentage of subjects | NUMBER | |
| SECONDARY | Freedom From Metastasis | 3 years | The number of participants analyzed for this outcome measure only includes the 29 participants who had documented disease progression (by RECIST 1.1 criteria) during study participation. | percentage of subjects | NUMBER |
| SECONDARY | Median Time To Progression | 3 years | The number of participants analyzed for this outcome measure includes only the 11 participants who achieved either a complete or partial response by RECIST 1.1 criteria during study participation. | months | MEDIAN |
| SECONDARY | Median Overall Survival | 4 years | months | MEDIAN | |
| SECONDARY | Clinical Benefit Rate | 3 years | percentage of subjects | NUMBER | |
| SECONDARY | Site of Failure | 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability | 3 years | percentage of subjects | NUMBER | |
| SECONDARY | Drug Compliance | 3 years | percentage of subjects | NUMBER | |
| SECONDARY | Quality of Life, as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ), 2007 | 3 years | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults 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) | Dasatinib and mFOLFOX6 | 4 | 95% Confidence Interval 2.3 to 8.5 | months | |
| Response Rate | Dasatinib and mFOLFOX6 | 25 | 95% Confidence Interval 13.19 to 40.34 | percentage of subjects | |
| Freedom From Metastasis | Dasatinib and mFOLFOX6 | 65.5 | 95% Confidence Interval 45.7 to 82.1 | percentage of subjects | |
| Median Time To Progression | Dasatinib and mFOLFOX6 | 9.8 | 90% Confidence Interval 8.6 to 19.5 | months | |
| Median Overall Survival | Dasatinib and mFOLFOX6 | 10.6 | 95% Confidence Interval 6.9 to 12.7 | months | |
| Clinical Benefit Rate | Dasatinib and mFOLFOX6 | 56.82 | 95% Confidence Interval 41.03 to 71.65 | percentage of subjects | |
| Site of Failure | Dasatinib and mFOLFOX6 | Left pleural effusion | 1 | Participants | |
| Site of Failure | Dasatinib and mFOLFOX6 | Liver | 12 | Participants | |
| Site of Failure | Dasatinib and mFOLFOX6 | Lungs | 3 | Participants | |
| Site of Failure | Dasatinib and mFOLFOX6 | Pancreas/liver | 4 | 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 | Dasatinib and mFOLFOX6 | 44 | |
| Overall Study | COMPLETED | Dasatinib and mFOLFOX6 | 44 | |
| Overall Study | NOT COMPLETED | Dasatinib and mFOLFOX6 | 0 |
Source ClinicalTrials.gov
Adverse events86
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 | Vomiting | Gastrointestinal disorders | Treatment Arm | 26 | 44 | |
| other | Urinary frequency | Renal and urinary disorders | Treatment Arm | 4 | 44 | |
| other | Upper respiratory tract infection | Infections and infestations | Treatment Arm | 7 | 44 | |
| other | Sore throat | Respiratory, thoracic and mediastinal disorders | Treatment Arm | 3 | 44 | |
| other | Skin and subcutaneous disorders, other | Skin and subcutaneous tissue disorders | Treatment Arm | 5 | 44 | |
| other | Weight Loss | Investigations | Treatment Arm | 11 | 44 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Treatment Arm | 7 | 44 | |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Treatment Arm | 9 | 44 | |
| other | Platelet count decreased | Investigations | Treatment Arm | 8 | 44 | |
| other | Peripheral sensory Neuropathy | Nervous system disorders | Treatment Arm | 30 | 44 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm | 42 | 44 |
| Total, other adverse events | Treatment Arm | 44 | 44 |
| Total, serious adverse events | Treatment Arm | 24 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24457377 | DERIVED |
Source PubMed
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/NCT01652976
GET https://conductscience.org/api/trials/v1/NCT01652976/results?page=2