Trial · NCT02352831
Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma
NCT02352831, Phase 1, Phase 2, Terminated, Washington University School of Medicine; results first posted 2018-12-17
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma. Trials, record NCT02352831. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02352831
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma
- NCT number
- NCT02352831
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Pancreatic Cancer, Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer
- Interventions
- Tosedostat, Capecitabine, Fresh tissue biopsy
- First posted
- 2015-02-02
- Last updated
- 2019-08-28
- Results first posted
- 2018-12-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I Only: Recommended Phase II Dose of Tosedostat | Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months) | The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. If 0 or 1 of 6 patients in Dose Level 1 experience DLT during the first cycle, Dose Level 1 will be presumed to be the RP2D. DLTs are followed through completion of the first cycle. |
| Primary | Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLTs) | Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months) | * Possibly/probably/definitely related to study treatment in 1st cycle (cyc) \*Grade (Gr) 4 neutropenia \>7 day, Febrile neutropenia of any duration with temperature ≥ 38.5 °C, Gr 4 anemia requires transfusion therapy on more than 2 occasions in 7 days, Gr 4 thrombocytopenia * Possibly/probably/definitely related gr. 3/4 non-hematologic toxicity that occurs 1st cyc with the following EXCEPTIONS: * Gr 3 nausea/vomiting/diarrhea/anorexia \<72 hours that returns to Gr 1 prior to the start of cyc 2, Gr 3 hand-foot syndrome will only be considered a DLT for patients who have received 1 week of supportive care treatment with no improvement, Gr 3 fatigue that returns to Gr 1 prior to the start of cyc 2, Gr 3 flu-like symptoms \<72 hours that returns to Gr 1 prior to start of cyc 2, Gr 3 arthralgia or myalgias \<72 hours that return to Gr 1 prior to the start of cyc 2, Gr 3 potassium/phosphorus/magnesium that is asymptomatic or of non-clinical significance \<72 hours, Gr 3 hypoalbuminemia |
| Primary | Progression-free Survival (PFS) Rate | 3 months | * PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD) * Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). * Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. |
| Secondary | Overall Response Rate (ORR) | Up to 18 months | * ORR = Complete response + partial response * Target lesions * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Non target lesions \*Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). |
| Secondary | Time-to-progression (TTP) | Up to 24 months | -Progressive disease (PD) * Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). * Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase |
| Secondary | Overall Survival Rate (OS) | Up to 1 year from completion of treatment (median treatment length 81.50 days (28.00-346.00) | |
| Secondary | Number of Participants With a CA19-9 Response | Completion of treatment (median treatment length 81.50 days (28.00-346.00) | * CA19-9 is a tumor marker that is used in the management of pancreatic cancer. Rising CA19-9 levels may mean the tumor is growing and decreasing CA19-9 levels may mean the tumor is shrinking or the amount of cancer in the body is decreasing * A CA19-9 response means that the tumor marker has decreased over baseline (before treatment started) levels |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I Only: Recommended Phase II Dose of Tosedostat | Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months) | This outcome measure is for Phase I participants only. | mg daily | NUMBER |
| PRIMARY | Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLTs) | Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months) | This outcome measure is for Phase I participants only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (PFS) Rate | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rate (ORR) | Up to 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time-to-progression (TTP) | Up to 24 months | days | MEDIAN | |
| SECONDARY | Overall Survival Rate (OS) | Up to 1 year from completion of treatment (median treatment length 81.50 days (28.00-346.00) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a CA19-9 Response | Completion of treatment (median treatment length 81.50 days (28.00-346.00) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I Only: Recommended Phase II Dose of Tosedostat | Phase I (Tosedostat + Capecitabine) | 120 | mg daily | ||
| Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLTs) | Phase I (Tosedostat + Capecitabine) | 1 | Participants | ||
| Progression-free Survival (PFS) Rate | Phase I (Tosedostat + Capecitabine) | 3 | Participants | ||
| Progression-free Survival (PFS) Rate | Phase II (Tosedostat + Capecitabine) | 8 | Participants | ||
| Progression-free Survival (PFS) Rate | Phase I and Phase II Combined | 11 | Participants | ||
| Overall Response Rate (ORR) | Phase I (Tosedostat + Capecitabine) | 0 | Participants | ||
| Overall Response Rate (ORR) | Phase II (Tosedostat + Capecitabine) | 0 | Participants | ||
| Time-to-progression (TTP) | Phase I (Tosedostat + Capecitabine) | 210.50 | Full Range 44.00 to 681.00 | days | |
| Time-to-progression (TTP) | Phase II (Tosedostat + Capecitabine) | 94.50 | Full Range 42.00 to 250.00 | days | |
| Overall Survival Rate (OS) | Phase I (Tosedostat + Capecitabine) | 3 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I (Tosedostat + Capecitabine) | 6 | |
| Overall Study | STARTED | Phase II (Tosedostat + Capecitabine) | 10 | |
| Overall Study | COMPLETED | Phase I (Tosedostat + Capecitabine) | 6 | |
| Overall Study | COMPLETED | Phase II (Tosedostat + Capecitabine) | 10 | |
| Overall Study | NOT COMPLETED | Phase I (Tosedostat + Capecitabine) | 0 | |
| Overall Study | NOT COMPLETED | Phase II (Tosedostat + Capecitabine) | 0 |
Source ClinicalTrials.gov
Adverse events130
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 | Anemia | Blood and lymphatic system disorders | Phase I (Tosedostat + Capecitabine) | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II (Tosedostat + Capecitabine) | 2 | 10 | |
| other | Blurred vision | Eye disorders | Phase I (Tosedostat + Capecitabine) | 0 | 6 | |
| other | Blurred vision | Eye disorders | Phase II (Tosedostat + Capecitabine) | 2 | 10 | |
| other | Dry eye | Eye disorders | Phase I (Tosedostat + Capecitabine) | 0 | 6 | |
| other | Dry eye | Eye disorders | Phase II (Tosedostat + Capecitabine) | 1 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase I (Tosedostat + Capecitabine) | 0 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase II (Tosedostat + Capecitabine) | 3 | 10 | |
| other | Constipation | Gastrointestinal disorders | Phase I (Tosedostat + Capecitabine) | 1 | 6 | |
| other | Constipation | Gastrointestinal disorders | Phase II (Tosedostat + Capecitabine) | 0 | 10 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I (Tosedostat + Capecitabine) | 1 | 6 |
| Total, all-cause mortality | Phase II (Tosedostat + Capecitabine) | 1 | 10 |
| Total, other adverse events | Phase I (Tosedostat + Capecitabine) | 6 | 6 |
| Total, other adverse events | Phase II (Tosedostat + Capecitabine) | 10 | 10 |
| Total, serious adverse events | Phase I (Tosedostat + Capecitabine) | 3 | 6 |
| Total, serious adverse events | Phase II (Tosedostat + Capecitabine) | 3 | 10 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase I (Tosedostat + Capecitabine) vs Phase II (Tosedostat + Capecitabine): Number of Participants With a CA19-9 Response | Trial comparisons |
| Phase I (Tosedostat + Capecitabine) vs Phase II (Tosedostat + Capecitabine): Overall Response Rate (ORR) | Trial comparisons |
| Phase I (Tosedostat + Capecitabine) vs Phase II (Tosedostat + Capecitabine): deaths from any cause | Trial comparisons |
| Phase I (Tosedostat + Capecitabine) vs Phase II (Tosedostat + Capecitabine): 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.
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/NCT02352831
GET https://conductscience.org/api/trials/v1/NCT02352831/events?page=2