Trial · NCT01479465
Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
NCT01479465, Phase 2, Terminated, Gilead Sciences; results first posted 2019-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma. Trials, record NCT01479465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01479465
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
- NCT number
- NCT01479465
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 266 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Colorectal Cancer
- Interventions
- Simtuzumab, Placebo to match SIM, Leucovorin, Irinotecan, Fluorouracil
- First posted
- 2011-11-24
- Last updated
- 2019-04-17
- Other registries' IDs
- eudract:2011-003754-61
- Results first posted
- 2019-04-17
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) | Randomization up to 27 months | The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates. |
| Secondary | Overall Survival (OS) | Randomization up to 33 months | The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates. |
| Secondary | Objective Response Rate (ORR) | Randomization up to 27 months | Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR. |
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) | Randomization up to 27 months | Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization up to 33 months | Participants in the Full Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Randomization up to 27 months | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
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) | FOLFIRI + SIM 700 mg (Part A) | 5.7 | 95% Confidence Interval 1.8 to 10.0 | months | |
| Progression Free Survival (PFS) | FOLFIRI + Placebo (Part B) | 5.8 | 95% Confidence Interval 4.9 to 9.0 | months | |
| Progression Free Survival (PFS) | FOLFIRI + SIM 200 mg (Part B) | 5.4 | 95% Confidence Interval 3.4 to 5.6 | months | |
| Progression Free Survival (PFS) | FOLFIRI + SIM 700 mg (Part B) | 5.5 | 95% Confidence Interval 4.0 to 7.1 | months | |
| Overall Survival (OS) | FOLFIRI + SIM 700 mg (Part A) | 9.8 | 95% Confidence Interval 3.5 to 22.3 | months | |
| Overall Survival (OS) | FOLFIRI + Placebo (Part B) | 16.3 | 95% Confidence Interval 12.0 to 19.5 | months | |
| Overall Survival (OS) | FOLFIRI + SIM 200 mg (Part B) | 10.5 | 95% Confidence Interval 9.2 to 12.6 | months | |
| Overall Survival (OS) | FOLFIRI + SIM 700 mg (Part B) | 11.4 | 95% Confidence Interval 9.7 to 15.6 | months | |
| Objective Response Rate (ORR) | FOLFIRI + SIM 700 mg (Part A) | 9.1 | 95% Confidence Interval 0.2 to 41.3 | percentage of participants | |
| Objective Response Rate (ORR) | FOLFIRI + Placebo (Part B) | 10.0 | 95% Confidence Interval 4.4 to 18.8 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FOLFIRI + SIM 700 mg (Part A) | 11 | |
| Overall Study | STARTED | FOLFIRI + Placebo (Part B) | 84 | |
| Overall Study | STARTED | FOLFIRI + SIM 200 mg (Part B) | 86 | |
| Overall Study | STARTED | FOLFIRI + SIM 700 mg (Part B) | 85 | |
| Overall Study | COMPLETED | FOLFIRI + SIM 700 mg (Part A) | 0 | |
| Overall Study | COMPLETED | FOLFIRI + Placebo (Part B) | 0 | |
| Overall Study | COMPLETED | FOLFIRI + SIM 200 mg (Part B) | 0 | |
| Overall Study | COMPLETED | FOLFIRI + SIM 700 mg (Part B) | 0 | |
| Overall Study | NOT COMPLETED | FOLFIRI + SIM 700 mg (Part A) | 11 | |
| Overall Study | NOT COMPLETED | FOLFIRI + Placebo (Part B) | 84 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events740
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 | FOLFIRI + SIM 700 mg (Part A) | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | FOLFIRI + Placebo (Part B) | 19 | 80 | |
| other | Anaemia | Blood and lymphatic system disorders | FOLFIRI + SIM 200 mg (Part B) | 23 | 85 | |
| other | Anaemia | Blood and lymphatic system disorders | FOLFIRI + SIM 700 mg (Part B) | 18 | 84 | |
| other | Leukopenia | Blood and lymphatic system disorders | FOLFIRI + SIM 700 mg (Part A) | 1 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | FOLFIRI + Placebo (Part B) | 9 | 80 | |
| other | Leukopenia | Blood and lymphatic system disorders | FOLFIRI + SIM 200 mg (Part B) | 13 | 85 | |
| other | Leukopenia | Blood and lymphatic system disorders | FOLFIRI + SIM 700 mg (Part B) | 13 | 84 | |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFIRI + SIM 700 mg (Part A) | 6 | 11 | |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFIRI + Placebo (Part B) | 35 | 80 |
1 to 10 of 740Source ClinicalTrials.gov
See all 740 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FOLFIRI + SIM 700 mg (Part A) | ||
| Total, all-cause mortality | FOLFIRI + Placebo (Part B) | ||
| Total, all-cause mortality | FOLFIRI + SIM 200 mg (Part B) | ||
| Total, all-cause mortality | FOLFIRI + SIM 700 mg (Part B) | ||
| Total, other adverse events | FOLFIRI + SIM 700 mg (Part A) | 11 | 11 |
| Total, other adverse events | FOLFIRI + Placebo (Part B) | 76 | 80 |
| Total, other adverse events | FOLFIRI + SIM 200 mg (Part B) | 80 | 85 |
| Total, other adverse events | FOLFIRI + SIM 700 mg (Part B) | 79 | 84 |
| Total, serious adverse events | FOLFIRI + SIM 700 mg (Part A) | 4 | 11 |
| Total, serious adverse events | FOLFIRI + Placebo (Part B) | 27 | 80 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28246207 | 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/NCT01479465
GET https://conductscience.org/api/trials/v1/NCT01479465/events?page=2