Trial · NCT01647828
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
NCT01647828, Phase 1, Phase 2, Completed, OncoMed Pharmaceuticals, Inc.; results first posted 2023-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer. Trials, record NCT01647828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01647828
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
- NCT number
- NCT01647828
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 217 participants, actual
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Conditions
- Stage IV Pancreatic Cancer
- Interventions
- OMP-59R5, Gemcitabine, Placebo, Nab-Paclitaxel
- First posted
- 2012-07-24
- Last updated
- 2023-02-15
- Results first posted
- 2023-02-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | Up to 1 year in absence of unacceptable toxicity or disease progression. | Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD). |
| Primary | Phase 2: Overall Survival (ITT Population) | Up to 1 year in absence of unacceptable toxicity or disease progression. | To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer. |
| Primary | Phase 2: Median OS by Notch 3 Percentile (ITT Population) | Up to 1 year in absence of unacceptable toxicity or disease progression. | To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | Up to 1 year in absence of unacceptable toxicity or disease progression. | The DLT Evaluable Population comprised all participants who received at least 1 partial dose of tarextumab during the Phase 1b dose escalation portion of the study (enrolled before the MTD was determined) and who completed Day 15 of Cycle 1 tarextumab administration or discontinued due to drug-related toxicity. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Survival (ITT Population) | Up to 1 year in absence of unacceptable toxicity or disease progression. | participants | NUMBER | |
| PRIMARY | Phase 2: Median OS by Notch 3 Percentile (ITT Population) | Up to 1 year in absence of unacceptable toxicity or disease progression. | The Intent-to-Treat (ITT) Population comprised all participants who received at least 1 partial dose of tarextumab. Here, Overall Number of Participants Analyzed = number of participants with Notch 3 ≥ 25th percentile, and Number Analyzed = number of participants in each Notch 3 percentile subset. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | P1B: OMP-59R5 2.5 mg/kg + Gem | 0 | Participants | ||
| Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | P1B: OMP-59R5 5 mg/kg + Gem | 0 | Participants | ||
| Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | P1B: OMP-59R5 5 mg/kg + Nab-P + Gem | 0 | Participants | ||
| Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem | 0 | Participants | ||
| Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | P1B: OMP-59R5 10 mg/kg + Nab-P + Gem | 0 | Participants | ||
| Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem | 0 | Participants | ||
| Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT) | P1B: OMP-59R5 15 mg/kg + Nab-P + Gem | 1 | Participants | ||
| Phase 2: Overall Survival (ITT Population) | P2: Placebo + Nab-P + Gem | Number of subjects who died | 60 | participants | |
| Phase 2: Overall Survival (ITT Population) | P2: OMP-59R5 15 mg/kg + Nab-P + Gem | Number of subjects who died | 71 | participants | |
| Phase 2: Overall Survival (ITT Population) | P2: Placebo + Nab-P + Gem | Number of subjects who did not die | 28 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | P1B: OMP-59R5 2.5 mg/kg + Gem | 5 | |
| Overall Study | STARTED | P1B: OMP-59R5 5 mg/kg + Gem | 4 | |
| Overall Study | STARTED | P1B: OMP-59R5 5 mg/kg + Nab-P + Gem | 4 | |
| Overall Study | STARTED | P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem | 6 | |
| Overall Study | STARTED | P1B: OMP-59R5 10 mg/kg + Nab-P + Gem | 6 | |
| Overall Study | STARTED | P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem | 3 | |
| Overall Study | STARTED | P1B: OMP-59R5 15 mg/kg + Nab-P + Gem | 12 | |
| Overall Study | STARTED | P2: Placebo + Nab-P + Gem | 88 | |
| Overall Study | STARTED | P2: OMP-59R5 15 mg/kg + Nab-P + Gem | 89 | |
| Overall Study | COMPLETED | P1B: OMP-59R5 2.5 mg/kg + Gem | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events5,310
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 | Thrombocytopenia | Blood and lymphatic system disorders | P1B: OMP-59R5 2.5 mg/kg + Gem | 3 | 5 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P1B: OMP-59R5 5 mg/kg + Gem | 2 | 4 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P1B: OMP-59R5 5 mg/kg + Nab-P + Gem | 4 | 4 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem | 5 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P1B: OMP-59R5 10 mg/kg + Nab-P + Gem | 5 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem | 2 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P1B: OMP-59R5 15 mg/kg + Nab-P + Gem | 7 | 12 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P2: Placebo + Nab-P + Gem | 38 | 85 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | P2: OMP-59R5 15 mg/kg + Nab-P + Gem | 62 | 87 | |
| other | Anemia | Blood and lymphatic system disorders | P1B: OMP-59R5 2.5 mg/kg + Gem | 4 | 5 |
1 to 10 of 5,310Source ClinicalTrials.gov
See all 5,310 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | P1B: OMP-59R5 2.5 mg/kg + Gem | 3 | 5 |
| Total, all-cause mortality | P1B: OMP-59R5 5 mg/kg + Gem | 4 | 4 |
| Total, all-cause mortality | P1B: OMP-59R5 5 mg/kg + Nab-P + Gem | 4 | 4 |
| Total, all-cause mortality | P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem | 5 | 6 |
| Total, all-cause mortality | P1B: OMP-59R5 10 mg/kg + Nab-P + Gem | 6 | 6 |
| Total, all-cause mortality | P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem | 3 | 3 |
| Total, all-cause mortality | P1B: OMP-59R5 15 mg/kg + Nab-P + Gem | 10 | 12 |
| Total, all-cause mortality | P2: Placebo + Nab-P + Gem | 60 | 88 |
| Total, all-cause mortality | P2: OMP-59R5 15 mg/kg + Nab-P + Gem | 71 | 89 |
| Total, other adverse events | P1B: OMP-59R5 2.5 mg/kg + Gem | 5 | 5 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31347292 | 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/NCT01647828
GET https://conductscience.org/api/trials/v1/NCT01647828/flow?page=2