Clinical trial · Interventional
Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer
NCT01507545CI-TRIAL-00058307terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): By the sponsor at the end of Stage 1 due to futility.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive care | Other | — | UNRESOLVED |
| MORAb-004 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MORAb-004
- interventionNames
- Drug: MORAb-004
- Other: Best supportive care
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
- Other: Best supportive care
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females \>18 years old * Diagnosis of metastatic, colorectal cancer * Significant medical conditions must be well-controlled and stable for at least 30 days prior to the first treatment infusion * Be willing and able to provide written informed consent Exclusion Criteria: * No prior treatment for metastatic colorectal cancer * Other serious systemic diseases (bacterial or fungal) * Clinically significant heart disease or an arrhythmia on an ECG within the past 6 months * Known allergic reaction to monoclonal antibody therapy
References
Publications (0)
Data not yet available
No reference posted for this study.