Trial · NCT05824559
ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
NCT05824559, Phase 1, Terminated, MEI Pharma, Inc.; results first posted 2024-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer. Trials, record NCT05824559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05824559
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
- NCT number
- NCT05824559
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- MEI Pharma, Inc.
- Conditions
- Colorectal Cancer
- Interventions
- ME-344, Bevacizumab
- First posted
- 2023-04-21
- Last updated
- 2024-11-21
- Results first posted
- 2024-11-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Rate at 16 Weeks | 16 weeks | Progression Free Survival is measured by using laboratory testing and scans. It is measured by the length of time from first dose of study drug until observation of disease progression. |
| Secondary | Overall Response Rate (ORR) | 6 months | Overall Response Rate (ORR) is defined/measured by the proportion of patients achieving complete response \[CR\] or partial response \[PR\] per RECIST v.1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Treatment Emergent Adverse Events for ME-344 Administered in Combination With Bevacizumab | from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months | This will be measured by the number of participants with at least one treatment emergent Adverse Events (abnormal physical examination findings, abnormal vital signs, abnormal ECG QT interval and abnormal clinical laboratory results) |
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 | Progression Free Survival (PFS) Rate at 16 Weeks | 16 weeks | All patients had relapsed metastatic colorectal cancer. | percentage | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment Emergent Adverse Events for ME-344 Administered in Combination With Bevacizumab | from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
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) Rate at 16 Weeks | ME-344 and Bevacizumab | 31.8 | percentage | ||
| Overall Response Rate (ORR) | ME-344 and Bevacizumab | Complete Response | 0 | Participants | |
| Overall Response Rate (ORR) | ME-344 and Bevacizumab | Partial Response | 0 | Participants | |
| Overall Response Rate (ORR) | ME-344 and Bevacizumab | Stable Disease | 9 | Participants | |
| Overall Response Rate (ORR) | ME-344 and Bevacizumab | Progressive Disease | 10 | Participants | |
| Overall Response Rate (ORR) | ME-344 and Bevacizumab | Not Available | 4 | Participants | |
| Treatment Emergent Adverse Events for ME-344 Administered in Combination With Bevacizumab | ME-344 and Bevacizumab | 22 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ME-344 and Bevacizumab | 23 | |
| Overall Study | COMPLETED | ME-344 and Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | ME-344 and Bevacizumab | 23 |
Source ClinicalTrials.gov
Adverse events104
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 | Leukocytosis | Blood and lymphatic system disorders | ME-344 and Bevacizumab | 3 | 23 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | ME-344 and Bevacizumab | 2 | 23 | 2 |
| other | Atrial fibrillation | Cardiac disorders | ME-344 and Bevacizumab | 1 | 23 | 1 |
| other | Sinus bradycardia | Cardiac disorders | ME-344 and Bevacizumab | 1 | 23 | 1 |
| other | Ear pain | Ear and labyrinth disorders | ME-344 and Bevacizumab | 1 | 23 | 1 |
| other | Hypothyroidism | Endocrine disorders | ME-344 and Bevacizumab | 1 | 23 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | ME-344 and Bevacizumab | 8 | 23 | 8 |
| other | Constipation | Gastrointestinal disorders | ME-344 and Bevacizumab | 7 | 23 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | ME-344 and Bevacizumab | 7 | 23 | 7 |
| other | Nausea | Gastrointestinal disorders | ME-344 and Bevacizumab | 5 | 23 | 5 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ME-344 and Bevacizumab | 1 | 23 |
| Total, other adverse events | ME-344 and Bevacizumab | 22 | 23 |
| Total, serious adverse events | ME-344 and Bevacizumab | 11 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39725778 | 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/NCT05824559
GET https://conductscience.org/api/trials/v1/NCT05824559/events?page=2