Trial · NCT01574716
Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
NCT01574716, Phase 2, Completed, Morphotek; results first posted 2019-08-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation. Trials, record NCT01574716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01574716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
- NCT number
- NCT01574716
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 209 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Metastatic Soft Tissue Sarcoma
- Interventions
- MORAb-004, Gemcitabine, Docetaxel, Gemcitabine, Docetaxel, Placebo
- First posted
- 2012-04-10
- Last updated
- 2019-08-21
- Other registries' IDs
- eudract:2012-001399-12
- Results first posted
- 2019-08-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 2: Radiologic Progression-free Survival (PFS) | From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years) | PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause. |
| Secondary | Part 2: Symptomatic Progression-free Survival | From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years) | PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause. |
| Secondary | Part 2: Overall Survival (OS) | From date of first dose until date of death from any cause (up to approximately 3.5 years) | OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. |
| Secondary | Part 2: Overall Response Rate (ORR) | From date of first dose until disease progression (up to approximately 3.5 years) | ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Part 2: Radiologic Progression-free Survival Rate (PFR) | Weeks 12, 24, 48 and 52 | Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points. |
| Secondary | Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels | Up to approximately 3 years |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 2: Radiologic Progression-free Survival (PFS) | From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years) | The ITT population consisted of all randomized participants and were analyzed according to the treatment assigned by the IxRS. | weeks | MEDIAN |
| SECONDARY | Part 2: Symptomatic Progression-free Survival | From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years) | The ITT population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. | weeks | MEDIAN |
| SECONDARY | Part 2: Overall Survival (OS) | From date of first dose until date of death from any cause (up to approximately 3.5 years) | The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. | months | MEDIAN |
| SECONDARY | Part 2: Overall Response Rate (ORR) | From date of first dose until disease progression (up to approximately 3.5 years) | The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. | percentage of participants | NUMBER |
| SECONDARY | Part 2: Radiologic Progression-free Survival Rate (PFR) | Weeks 12, 24, 48 and 52 | The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. | percentage of participants | NUMBER |
| SECONDARY | Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels | Up to approximately 3 years | The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 2: Radiologic Progression-free Survival (PFS) | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 18.7 | 95% Confidence Interval 11.6 to 27.4 | weeks | |
| Part 2: Radiologic Progression-free Survival (PFS) | Part 2: Placebo + Gemcitabine/Docetaxel | 24.1 | 95% Confidence Interval 11.1 to 36.1 | weeks | |
| Part 2: Symptomatic Progression-free Survival | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 18.1 | 95% Confidence Interval 11.3 to 24.0 | weeks | |
| Part 2: Symptomatic Progression-free Survival | Part 2: Placebo + Gemcitabine/Docetaxel | 24.0 | 95% Confidence Interval 10.7 to 36.1 | weeks | |
| Part 2: Overall Survival (OS) | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 18.3 | 95% Confidence Interval 16.2 to 21.1 | months | |
| Part 2: Overall Survival (OS) | Part 2: Placebo + Gemcitabine/Docetaxel | 21.1 | 95% Confidence Interval 14.2 to NA | months | |
| Part 2: Overall Response Rate (ORR) | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 19.4 | percentage of participants | ||
| Part 2: Overall Response Rate (ORR) | Part 2: Placebo + Gemcitabine/Docetaxel | 20.0 | percentage of participants | ||
| Part 2: Radiologic Progression-free Survival Rate (PFR) | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 12 weeks | 57.6 | percentage of participants | |
| Part 2: Radiologic Progression-free Survival Rate (PFR) | Part 2: Placebo + Gemcitabine/Docetaxel | 12 weeks | 61.8 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | 3 | |
| Part 1 | STARTED | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | 4 | |
| Part 1 | STARTED | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 9 | |
| Part 1 | STARTED | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 0 | |
| Part 1 | STARTED | Part 2: Placebo + Gemcitabine/Docetaxel | 0 | |
| Part 1 | COMPLETED | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | 0 | |
| Part 1 | COMPLETED | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | 0 | |
| Part 1 | COMPLETED | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 0 | |
| Part 1 | COMPLETED | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 0 | |
| Part 1 | COMPLETED | Part 2: Placebo + Gemcitabine/Docetaxel | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events1,235
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 | Anaemia | Blood and lymphatic system disorders | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 8 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 85 | 140 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Placebo + Gemcitabine/Docetaxel | 37 | 67 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | 3 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | 0 | 4 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 8 | 9 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 56 | 140 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part 2: Placebo + Gemcitabine/Docetaxel | 28 | 67 |
1 to 10 of 1,235Source ClinicalTrials.gov
See all 1,235 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | 3 | 3 |
| Total, all-cause mortality | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | 1 | 4 |
| Total, all-cause mortality | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 8 | 9 |
| Total, all-cause mortality | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 76 | 140 |
| Total, all-cause mortality | Part 2: Placebo + Gemcitabine/Docetaxel | 35 | 67 |
| Total, other adverse events | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | 3 | 3 |
| Total, other adverse events | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | 4 | 4 |
| Total, other adverse events | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 9 | 9 |
| Total, other adverse events | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | 140 | 140 |
| Total, other adverse events | Part 2: Placebo + Gemcitabine/Docetaxel | 66 | 67 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31034598 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel vs Part 2: Placebo + Gemcitabine/Docetaxel: Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels |
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/NCT01574716
GET https://conductscience.org/api/trials/v1/NCT01574716/flow?page=2