Trial · NCT00570713
An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
NCT00570713, Phase 2, Completed, Morphotek; results first posted 2012-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer. Trials, record NCT00570713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00570713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
- NCT number
- NCT00570713
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Pancreatic Cancer
- Interventions
- MORAb-009, Placebo, Gemcitabine
- First posted
- 2007-12-11
- Last updated
- 2015-09-09
- Results first posted
- 2012-03-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 1-21 Months | This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up. |
| Secondary | Progression-free Survival | 1-21 Months | Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. 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. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment. |
| Secondary | Best Overall Response Rate | Baseline to response up to 21 months | Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD. |
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 | Overall Survival (OS) | 1-21 Months | Months | MEDIAN | |
| SECONDARY | Progression-free Survival | 1-21 Months | Months | MEDIAN | |
| SECONDARY | Best Overall Response Rate | Baseline to response up to 21 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | MORAb-009 Plus Gemcitabine ('MORAb-009') | 6.5 | 95% Confidence Interval 4.5 to 8.10 | Months | |
| Overall Survival (OS) | Placebo Plus Gemcitabine ('Placebo') | 6.9 | 95% Confidence Interval 5.4 to 8.8 | Months | |
| Progression-free Survival | MORAb-009 Plus Gemcitabine ('MORAb-009') | 3.4 | 95% Confidence Interval 1.9 to 4.7 | Months | |
| Progression-free Survival | Placebo Plus Gemcitabine ('Placebo') | 3.5 | 95% Confidence Interval 2.8 to 4.9 | Months | |
| Best Overall Response Rate | MORAb-009 Plus Gemcitabine ('MORAb-009') | Complete or Partial Response | 6.4 | percentage of participants | |
| Best Overall Response Rate | Placebo Plus Gemcitabine ('Placebo') | Complete or Partial Response | 7.8 | percentage of participants | |
| Best Overall Response Rate | MORAb-009 Plus Gemcitabine ('MORAb-009') | Complete Response | 0 | percentage of participants | |
| Best Overall Response Rate | Placebo Plus Gemcitabine ('Placebo') | Complete Response | 0 | percentage of participants | |
| Best Overall Response Rate | MORAb-009 Plus Gemcitabine ('MORAb-009') | Partial Response | 6.4 | percentage of participants | |
| Best Overall Response Rate | Placebo Plus Gemcitabine ('Placebo') | Partial Response | 7.8 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MORAb-009 Plus Gemcitabine ('MORAb-009') | 78 | |
| Overall Study | STARTED | Placebo Plus Gemcitabine ('Placebo') | 77 | |
| Overall Study | COMPLETED | MORAb-009 Plus Gemcitabine ('MORAb-009') | 0 | |
| Overall Study | COMPLETED | Placebo Plus Gemcitabine ('Placebo') | 0 | |
| Overall Study | NOT COMPLETED | MORAb-009 Plus Gemcitabine ('MORAb-009') | 78 | |
| Overall Study | NOT COMPLETED | Placebo Plus Gemcitabine ('Placebo') | 77 |
Source ClinicalTrials.gov
Adverse events390
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 | Nausea | Gastrointestinal disorders | MORAb-009 Plus Gemcitabine ('MORAb-009') | 35 | 73 | |
| other | Nausea | Gastrointestinal disorders | Placebo Plus Gemcitabine ('Placebo') | 38 | 75 | |
| other | Constipation | Gastrointestinal disorders | MORAb-009 Plus Gemcitabine ('MORAb-009') | 34 | 73 | |
| other | Constipation | Gastrointestinal disorders | Placebo Plus Gemcitabine ('Placebo') | 27 | 75 | |
| other | Abdominal pain | Gastrointestinal disorders | MORAb-009 Plus Gemcitabine ('MORAb-009') | 27 | 73 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Plus Gemcitabine ('Placebo') | 20 | 75 | |
| other | Vomiting | Gastrointestinal disorders | MORAb-009 Plus Gemcitabine ('MORAb-009') | 23 | 73 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Plus Gemcitabine ('Placebo') | 24 | 75 | |
| other | Diarrhoea | Gastrointestinal disorders | MORAb-009 Plus Gemcitabine ('MORAb-009') | 22 | 73 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Plus Gemcitabine ('Placebo') | 23 | 75 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MORAb-009 Plus Gemcitabine ('MORAb-009') | ||
| Total, all-cause mortality | Placebo Plus Gemcitabine ('Placebo') | ||
| Total, other adverse events | MORAb-009 Plus Gemcitabine ('MORAb-009') | 73 | 73 |
| Total, other adverse events | Placebo Plus Gemcitabine ('Placebo') | 75 | 75 |
| Total, serious adverse events | MORAb-009 Plus Gemcitabine ('MORAb-009') | 49 | 73 |
| Total, serious adverse events | Placebo Plus Gemcitabine ('Placebo') | 54 | 75 |
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 |
|---|
| MORAb-009 Plus Gemcitabine ('MORAb-009') vs Placebo Plus Gemcitabine ('Placebo'): 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/NCT00570713
GET https://conductscience.org/api/trials/v1/NCT00570713/events?page=2