Trial · NCT01507545
Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
NCT01507545, Phase 2, Terminated, Morphotek; results first posted 2022-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO). Trials, record NCT01507545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01507545
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
- NCT number
- NCT01507545
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 154 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Metastatic Colorectal Cancer, Colorectal Cancer
- Interventions
- MORAb-004, Placebo, Best supportive care
- First posted
- 2012-01-11
- Last updated
- 2022-05-06
- Results first posted
- 2022-05-06
- Limitations and caveats
- The study was terminated by the sponsor at the end of Stage 1 due to futility, hence Stage 2 was not carried out.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months) | PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression (PD) or death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further antitumor treatment. PFS was summarized for each treatment group using Kaplan-Meier estimation curves. |
| Secondary | Overall Survival (OS) | From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months) | OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. OS was summarized for each treatment group using Kaplan-Meier estimation curves. In the absence of death confirmation or for participants alive at the time of analysis, the survival time was censored at the last date known to be alive. |
| Secondary | Overall Response Rate (ORR) | From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months) | ORR was defined as the percentage of subjects achieving either CR or PR using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Time to Tumor Response (TTR) | From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months) | Time to tumor response was defined for those participants with objective evidence of confirmed CR or PR as the time from randomization to first documentation of objective tumor response (CR or PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Response (DOR) | From the date of first objective response (CR or PR) to objective tumor progression or death regardless of cause (up to approximately 1 year 7 months) | The DOR was defined as the time from first documentation of objective response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Biomarkers Based PFS, Within Treatment Group | From the date of randomization up to approximately 1 year 7 months | The statistical evidence to support the use of the biomarker identified in Stage 1 interim analysis for Stage 2 selection of participants as designed was not adequate to clearly define a biomarker responsive population. The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for PFS was not carried out. |
| Secondary | Biomarkers Based OS, Within Treatment Group | From the date of randomization up to approximately 1 year 7 months | The statistical evidence to support the use of the biomarker identified in Stage 1 interim analysis for Stage 2 selection of participants as designed was not adequate to clearly define a biomarker responsive population. The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for OS was not carried out. |
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 | Progression-Free Survival (PFS) | From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months) | ITT population included all randomized participants, analyzed according to the treatment assigned by the IVRS/IWRS. | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months) | ITT population included all randomized participants, analyzed according to the treatment assigned by IVRS/IWRS. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months) | ITT population included all randomized participants, analyzed according to the treatment assigned by IVRS/IWRS. | percentage of participants | NUMBER |
| SECONDARY | Time to Tumor Response (TTR) | From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months) | ITT population included all randomized participants, analyzed according to the treatment assigned by the IVRS/IWRS.~Here overall number analyzed N are the participants who had achieved CR or PR. | weeks | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the date of first objective response (CR or PR) to objective tumor progression or death regardless of cause (up to approximately 1 year 7 months) | ITT population included all randomized participants, analyzed according to the treatment assigned by the IVRS/IWRS. Here overall number analyzed N are the participants who had achieved CR or PR. | weeks | MEDIAN |
| SECONDARY | Biomarkers Based PFS, Within Treatment Group | From the date of randomization up to approximately 1 year 7 months | The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for PFS was not carried out. | ||
| SECONDARY | Biomarkers Based OS, Within Treatment Group | From the date of randomization up to approximately 1 year 7 months | The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for OS was not carried out. |
Source ClinicalTrials.gov
Results by group8
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) | MORAb-004 8.0 mg/kg + BSC | 8.1 | 95% Confidence Interval 7.9 to 8.1 | weeks | |
| Progression-Free Survival (PFS) | Placebo + BSC | 8.1 | 95% Confidence Interval 8.0 to 8.3 | weeks | |
| Overall Survival (OS) | MORAb-004 8.0 mg/kg + BSC | 4.8 | 95% Confidence Interval 3.7 to 6.2 | months | |
| Overall Survival (OS) | Placebo + BSC | 6.2 | 95% Confidence Interval 4.7 to 9.7 | months | |
| Overall Response Rate (ORR) | MORAb-004 8.0 mg/kg + BSC | 0 | 95% Confidence Interval 0.000 to 4.296 | percentage of participants | |
| Overall Response Rate (ORR) | Placebo + BSC | 2.4 | 95% Confidence Interval 0.060 to 12.566 | percentage of participants | |
| Time to Tumor Response (TTR) | Placebo + BSC | NA | Full Range NA to NA | weeks | |
| Duration of Response (DOR) | Placebo + BSC | NA | Full Range NA to NA | weeks |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MORAb-004 8.0 mg/kg + BSC | 84 | |
| Overall Study | STARTED | Placebo + BSC | 42 | |
| Overall Study | Treated/Safety Set | MORAb-004 8.0 mg/kg + BSC | 82 | |
| Overall Study | Treated/Safety Set | Placebo + BSC | 40 | |
| Overall Study | COMPLETED | MORAb-004 8.0 mg/kg + BSC | 0 | |
| Overall Study | COMPLETED | Placebo + BSC | 0 | |
| Overall Study | NOT COMPLETED | MORAb-004 8.0 mg/kg + BSC | 84 | |
| Overall Study | NOT COMPLETED | Placebo + BSC | 42 |
Source ClinicalTrials.gov
Adverse events510
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 | MORAb-004 8.0 mg/kg + BSC | 10 | 82 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + BSC | 5 | 40 | |
| other | Lymphopenia | Blood and lymphatic system disorders | MORAb-004 8.0 mg/kg + BSC | 6 | 82 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + BSC | 0 | 40 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MORAb-004 8.0 mg/kg + BSC | 0 | 82 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + BSC | 1 | 40 | |
| other | Sinus Tachycardia | Cardiac disorders | MORAb-004 8.0 mg/kg + BSC | 4 | 82 | |
| other | Sinus Tachycardia | Cardiac disorders | Placebo + BSC | 0 | 40 | |
| other | Atrial Fibrillation | Cardiac disorders | MORAb-004 8.0 mg/kg + BSC | 1 | 82 | |
| other | Atrial Fibrillation | Cardiac disorders | Placebo + BSC | 0 | 40 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MORAb-004 8.0 mg/kg + BSC | 13 | 82 |
| Total, all-cause mortality | Placebo + BSC | 4 | 40 |
| Total, other adverse events | MORAb-004 8.0 mg/kg + BSC | 77 | 82 |
| Total, other adverse events | Placebo + BSC | 40 | 40 |
| Total, serious adverse events | MORAb-004 8.0 mg/kg + BSC | 31 | 82 |
| Total, serious adverse events | Placebo + BSC | 15 | 40 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MORAb-004 8.0 mg/kg + BSC vs Placebo + BSC: deaths from any cause | Trial comparisons |
| MORAb-004 8.0 mg/kg + BSC vs Placebo + BSC: 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.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01507545/events?page=2